rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients W... | NCT03687957 | Trialant
NCT03687957
Sponsor
Washington University School of Medicine
Status
Active, not recruiting
Last Update Posted
Nov 25, 2025Actual
Enrollment
42Actual
Phase
Phase 1Phase 2
Conditions
Glioma
Interventions
rhIL-7-hyFc
Placebo
Temozolomide
Radiation therapy
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03687957
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
201810185
Secondary IDs
Not provided
Brief Title
rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide
Official Title
Effect of rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide
Acronym
Not provided
Organization
Washington University School of MedicineOTHER
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 4, 2019Actual
Primary Completion Date
Feb 13, 2023Actual
Completion Date
Apr 13, 2028Estimated
First Submitted Date
Sep 25, 2018
First Submission Date that Met QC Criteria
Sep 25, 2018
First Posted Date
Sep 27, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 30, 2025
Results First Submitted that Met QC Criteria
Nov 13, 2025
Results First Posted Date
Nov 25, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 13, 2025
Last Update Posted Date
Nov 25, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Washington University School of MedicineOTHER
Collaborators
Name
Class
NeoImmuneTech
INDUSTRY
The Foundation for Barnes-Jewish Hospital
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The investigators have developed a phase I/II clinical trial to evaluate the effect of rhIL-7-hyFc on lymphocyte counts in patients with high grade glioma (HGG).
A phase I study will test whether rhIL-7-hyFc can be safely administered to patients with HGG. Six doses of rhIL-7-hyFc will be tested using a mix of Accelerated Phase and standard 3+3 dose-escalation design. The phase II portion to test effect of rhIL-7-hyFc on lymphocyte counts will use placebo-controlled randomization in HGG patients whose treatment include the standard radiation therapy (RT) and temozolomide (TMZ).
Detailed Description
Not provided
Conditions Module
Conditions
Glioma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
42Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)
Experimental
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
Drug: rhIL-7-hyFc
Drug: Temozolomide
Radiation: Radiation therapy
Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)
Experimental
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
Interventions
Name
Type
Description
Arm Group Labels
Other Names
rhIL-7-hyFc
Drug
-Given by intramuscular injection
Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase I Only: Safety and Tolerability of rhIL-7-hyFc as Measured by the Maximum Tolerated Dose (MTD) of rhIL-7-hyFc
-The maximum tolerated dose (MTD) is defined as the dose level immediately below the non-tolerated dose. A total of at least 6 patients must be treated at a dose level for it to be considered the MTD.
Within 30 days of treatment start
Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs)
-DLTs are defined in the protocol.
Within 30 days of treatment start
Randomized Phase II: Percent Change in Absolute Lymphocyte Count (ALC)
Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system.
Baseline to Prior to adjuvant TMZ (approximately week 4)
Phase II Expansion Arm: Progression-free Survival (PFS)
-Defined from date of surgery to date of progression or death due to disease or date of last clinical follow up.
Through completion of follow-up (estimated to be 5 years and 6 months)
Secondary Outcomes
Measure
Description
Time Frame
Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs)
The formation of anti-drug antibodies (ADA) to rhIL-7-hyFc will be evaluated: BioAgilytix will perform both Elisa Binding (non-neutralizing) and neutralizing antibody assays according to their Standard Operating Procedure. The data will be presented if anti-drug antibodies are detected or not detected in the samples.
Week 1 will be prior to injection of 1st dose of rhIL-7-hyFc, week 13 will be prior to the 2nd dose of rhIL-7-hyFc, and week 45 will be 8 weeks after the last dose of rhIL-7-hyFc.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
World Health Organization (WHO) grade III, grade IV, and high risk grade II gliomas that require RT and TMZ treatment.
Phase 2 Expansion Cohort ONLY: Must be IDH1 wildtype, as defined by negative immunohistochemistry using an R132H-specific antibody and MGMT promoter unmethylated glioblastoma multiforme (WHO grade IV).
Post-operative treatment must have included radiation and TMZ. Prior Gliadel Wafers are allowed. Glucocorticoid therapy is allowed. Tumor treating fields (TTF) device is allowed.
Adequate organ and marrow function defined as follows:
Absolute neutrophil count ≥ 1,000/mcL
Platelets ≥ 75,000/mcL
Hemoglobin ≥ 8 g/dL
Total bilirubin ≤ 3.0 x institutional upper limit of normal
AST (SGOT)/ALT (SGPT) ≤ 3.0 × institutional upper limit of normal
Absolute lymphocyte count (ALC) ≥ 600/mcL (required for phase I and randomized phase II only)
Karnofsky Performance Status (KPS) ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
Able to provide written informed consent (or consent from a legally authorized representative).
Women of childbearing potential must have a negative serum pregnancy test prior to study entry (within 14 days). Patients must be willing to be on adequate contraception during treatment.
18 years of age.
Exclusion Criteria:
Receiving any other investigational agents which may affect patient's lymphocyte counts.
Pregnant women are excluded from this study because rhIL-7-hyFc has not been evaluated regarding its potential for teratogenic or abortifacients effects. There is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug, breastfeeding should be discontinued if the mother is treated with rhIL-7-hyFc.
Has an active viral infection requiring systemic treatment at screening.
Has active autoimmune disease or syndrome (i.e. moderate or severe rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.,) that requires systemic treatment at the time of screening. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Subjects are permitted to enroll if they have vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
Campian JL, Ghosh S, Kapoor V, Yan R, Thotala S, Jash A, Hu T, Mahadevan A, Rifai K, Page L, Lee BH, Ferrando-Martinez S, Wolfarth AA, Yang SH, Hallahan D, Chheda MG, Thotala D. Long-Acting Recombinant Human Interleukin-7, NT-I7, Increases Cytotoxic CD8 T Cells and Enhances Survival in Mouse Glioma Models. Clin Cancer Res. 2022 Mar 15;28(6):1229-1239. doi: 10.1158/1078-0432.CCR-21-0947.
See Also Links
Label
URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
The Phase II Expansion Arm never opened to enrollment and no participants were enrolled in this portion of the trial.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
May 15, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
-Phase I enrollment will be a sequential enrollment (patients will be stratified by concomitant use of steroids (yes/no). Phase II randomized portion will open with 2 arms being enrolled to in parallel. Phase II expansion cohort will not be randomized.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Phase II only: This study is triple-blinded (participant, physician, and study coordinator are all blinded; pharmacist and study statistician are not blinded)
Who Masked
ParticipantCare ProviderInvestigator
Drug: rhIL-7-hyFc
Drug: Temozolomide
Radiation: Radiation therapy
Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)
Experimental
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
Drug: rhIL-7-hyFc
Drug: Temozolomide
Radiation: Radiation therapy
Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)
Experimental
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
Drug: rhIL-7-hyFc
Drug: Temozolomide
Radiation: Radiation therapy
Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)
Experimental
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
Drug: rhIL-7-hyFc
Drug: Temozolomide
Radiation: Radiation therapy
Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)
Experimental
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
Drug: rhIL-7-hyFc
Drug: Temozolomide
Radiation: Radiation therapy
Randomized Phase II: Placebo
Experimental
-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of placebo injections are planned.
Drug: Placebo
Drug: Temozolomide
Radiation: Radiation therapy
Randomized Phase II: rhIL-7-hyFc
Experimental
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
Drug: rhIL-7-hyFc
Drug: Temozolomide
Radiation: Radiation therapy
Phase II Expansion Arm: rhIL-7-hyFc
Experimental
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
Drug: rhIL-7-hyFc
Drug: Temozolomide
Radiation: Radiation therapy
Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)
Phase II Expansion Arm: rhIL-7-hyFc
Randomized Phase II: rhIL-7-hyFc
Placebo
Drug
-Given by intramuscular injection
Randomized Phase II: Placebo
Temozolomide
Drug
-Standard of care
Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)
Phase II Expansion Arm: rhIL-7-hyFc
Randomized Phase II: Placebo
Randomized Phase II: rhIL-7-hyFc
TMZ
Radiation therapy
Radiation
-Standard of care
Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)
Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)
Phase II Expansion Arm: rhIL-7-hyFc
Randomized Phase II: Placebo
Randomized Phase II: rhIL-7-hyFc
RT
Week 1, Week 13, Week 25, and Week 45
Phase I: Percent Change in Absolute Lymphocyte Count (ALC)
Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system.
Baseline to Prior to adjuvant TMZ (approximately week 4)
FG001
Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
FG002
Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
FG003
Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
FG004
Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
FG005
Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
FG006
Randomized Phase II: Placebo
-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of placebo injections are planned.
FG007
Randomized Phase II: rhIL-7-hyFc
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
FG008
Randomized Phase II: Not Randomized
Enrolled to Randomized Phase II trial portion but not randomized.
FG009
Phase II Expansion Arm: rhIL-7-hyFc
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0036 subjects
FG0046 subjects
FG0052 subjects
FG00611 subjects
FG00711 subjects
FG0081 subjects
FG0090 subjects
COMPLETED
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0064 subjects
FG0075 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0036 subjects
FG0044 subjects
FG0052 subjects
FG0067 subjects
FG0076 subjects
FG0081 subjects
FG0090 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0063 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
Disease progression
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
New malignancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Patient went on hospice
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
BG001
Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
BG002
Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
BG003
Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
BG004
Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
BG005
Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
BG006
Randomized Phase II: Placebo
-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of placebo injections are planned.
BG007
Randomized Phase II: rhIL-7-hyFc
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
BG008
Randomized Phase II: Not Randomized
Enrolled to Randomized Phase II trial portion but not randomized.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0023
BG0036
BG0046
BG0052
BG00611
BG00711
BG0081
BG00942
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00057(57 to 57)
BG00132(32 to 32)
BG00246(45 to 66)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0001
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase I Only: Safety and Tolerability of rhIL-7-hyFc as Measured by the Maximum Tolerated Dose (MTD) of rhIL-7-hyFc
-The maximum tolerated dose (MTD) is defined as the dose level immediately below the non-tolerated dose. A total of at least 6 patients must be treated at a dose level for it to be considered the MTD.
All Phase I participants are evaluable for this outcome measure.
Posted
Number
mcg/kg
Within 30 days of treatment start
ID
Title
Description
OG000
Phase I: rhIL-7-hyFc All Dose Levels
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
Units
Counts
Participants
OG00019
Title
Denominators
Categories
Title
Measurements
OG000720
Primary
Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs)
-DLTs are defined in the protocol.
This outcome measure is for Phase I participants only.
Posted
Count of Participants
Participants
Within 30 days of treatment start
ID
Title
Description
OG000
Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG001
Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
Primary
Randomized Phase II: Percent Change in Absolute Lymphocyte Count (ALC)
Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system.
Only participants in the Randomized Phase II Placebo and Randomized Phase II rhIL-7-hyFc are evaluable for this outcome measure.
Posted
Median
Standard Deviation
percent change
Baseline to Prior to adjuvant TMZ (approximately week 4)
ID
Title
Description
OG000
Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG001
Primary
Phase II Expansion Arm: Progression-free Survival (PFS)
-Defined from date of surgery to date of progression or death due to disease or date of last clinical follow up.
The Phase II Expansion Arm of the trial never opened to enrollment and no participants were enrolled.
Posted
Through completion of follow-up (estimated to be 5 years and 6 months)
ID
Title
Description
OG000
Phase II Expansion Arm: rhIL-7-hyFc
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
Units
Counts
Participants
Secondary
Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs)
The formation of anti-drug antibodies (ADA) to rhIL-7-hyFc will be evaluated: BioAgilytix will perform both Elisa Binding (non-neutralizing) and neutralizing antibody assays according to their Standard Operating Procedure. The data will be presented if anti-drug antibodies are detected or not detected in the samples.
Week 1 will be prior to injection of 1st dose of rhIL-7-hyFc, week 13 will be prior to the 2nd dose of rhIL-7-hyFc, and week 45 will be 8 weeks after the last dose of rhIL-7-hyFc.
Samples were not collected at all time points if a participant was removed from treatment or removed from the study prior to that timepoint. Week 25 was removed with amendment #4 and only one participant had a sample collected at this time point.
Posted
Count of Participants
Participants
Week 1, Week 13, Week 25, and Week 45
ID
Title
Description
OG000
Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
Secondary
Phase I: Percent Change in Absolute Lymphocyte Count (ALC)
Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system.
Only Phase I participants are evaluable for this outcome measure.
Posted
Median
Standard Deviation
percent change
Baseline to Prior to adjuvant TMZ (approximately week 4)
ID
Title
Description
OG000
Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG001
Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)
Time Frame
Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
1
1
1
1
1
1
EG001
Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
1
1
1
1
1
1
EG002
Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
1
3
0
3
3
3
EG003
Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
5
6
2
6
5
6
EG004
Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
5
6
4
6
6
6
EG005
Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
2
2
1
2
2
2
EG006
Randomized Phase II: Placebo
-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of placebo injections are planned.
9
11
3
11
9
11
EG007
Randomized Phase II: rhIL-7-hyFc
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
10
11
4
11
11
11
EG008
Randomized Phase II: Not Randomized
Enrolled to Randomized Phase II trial portion but not randomized.
0
1
0
1
0
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Heart failure
Cardiac disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG0030 affected6 at risk
EG0041 affected6 at risk
EG0050 affected2 at risk
EG0060 affected11 at risk
EG0070 affected11 at risk
EG0081 at risk
Abdominal pain
Gastrointestinal disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Fever
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Suspected neoplasm progression
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
COVID-19 infection
Infections and infestations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Lung infection
Infections and infestations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Car accident injuries
Injury, poisoning and procedural complications
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Muscle weakness lower limb
Musculoskeletal and connective tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Muscle weakness right-sided
Nervous system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Seizure
Nervous system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Stroke
Nervous system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Confusion
Psychiatric disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG0030 affected6 at risk
EG0041 affected6 at risk
EG0050 affected2 at risk
EG0060 affected11 at risk
EG0070 affected11 at risk
EG0081 at risk
Sinus tachycardia
Cardiac disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hearing impaired
Ear and labyrinth disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Blurred vision
Eye disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Diplopia
Eye disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Diarrhea
Gastrointestinal disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Fecal incontinence
Gastrointestinal disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Disease progression
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Fever
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Gait disturbance
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Injection site reaction
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Eye infection
Infections and infestations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Sinus infection
Infections and infestations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Tooth infection
Infections and infestations
CTCAE (Unspecified)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Bruising
Injury, poisoning and procedural complications
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
CD4 lymphocytes decreased
Investigations
CTCAE (Unspecified)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0023 affected3 at risk
EG003
Platelet count decreased
Investigations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
White blood cell decreased
Investigations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Anorexia
Metabolism and nutrition disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Generalized muscle weakness
Musculoskeletal and connective tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Muscle weakness upper limb
Musculoskeletal and connective tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dysarthria
Nervous system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Paresthesia
Nervous system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Tremors
Nervous system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Renal calculi
Renal and urinary disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Rash acneiform
Skin and subcutaneous tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Skin atrophy
Skin and subcutaneous tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Skin ulceration
Skin and subcutaneous tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Biopsy and Interstitial Laser Thermal Therapy
Surgical and medical procedures
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected3 at risk
EG003
Hypertension
Vascular disorders
CTCAE (Unspecified)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Thromboembolic event
Vascular disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pain - starts in right foot and migrates to head
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pain - right side
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Edema limbs
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Flu like symptoms
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Allergic reaction
Immune system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Neutrophil count decreased
Investigations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Weight gain
Investigations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Weight loss
Investigations
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Muscle weakness lower limb
Musculoskeletal and connective tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Muscle weakness - right-sided
Nervous system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Seizure
Nervous system disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Altered mental status
Psychiatric disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Confusion
Psychiatric disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Irritability
Psychiatric disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
CTCAE (Unspecified)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected3 at risk
EG003
After completion of enrollment to the Phase I and Phase II Randomized portions of the trial, funding was depleted. Despite numerous attempts to gain new funding, the Phase II Expansion portion of the trial was never opened to enrollment. The results are late due to this reason.
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG003
Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG004
Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG005
Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG006
Randomized Phase II: Placebo
-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of placebo injections are planned.
OG007
Randomized Phase II: rhIL-7-hyFc
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
OG008
Randomized Phase II: Not Randomized
Enrolled to Randomized Phase II trial portion but not randomized.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0036
OG0046
OG0052
OG0060
OG0070
OG0080
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG002
Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG003
Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG004
Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG005
Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG006
Randomized Phase II: Placebo
-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of placebo injections are planned.
OG007
Randomized Phase II: rhIL-7-hyFc
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
OG008
Randomized Phase II: Not Randomized
Enrolled to Randomized Phase II trial portion but not randomized.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG00611
OG00711
OG0080
Title
Denominators
Categories
Title
Measurements
OG00616.66667± 28.36597
OG007147.8261± 285.9597
OG000
0
OG001
Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG002
Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG003
Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG004
Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG005
Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG006
Randomized Phase II: Placebo
-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of placebo injections are planned.
OG007
Randomized Phase II: rhIL-7-hyFc
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
OG008
Randomized Phase II: Not Randomized
Enrolled to Randomized Phase II trial portion but not randomized.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0036
OG0046
OG0052
OG00611
OG00711
OG0080
Title
Denominators
Categories
Week 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0052
ParticipantsOG00611
ParticipantsOG00711
ParticipantsOG0080
Title
Measurements
Detected
OG0000
OG0010
OG0020
OG003
Week 13
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0032
Week 25
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 45
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG002
Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG003
Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG004
Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG005
Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned
The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels
OG006
Randomized Phase II: Placebo
-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of placebo injections are planned.
OG007
Randomized Phase II: rhIL-7-hyFc
Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.
OG008
Randomized Phase II: Not Randomized
Enrolled to Randomized Phase II trial portion but not randomized.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG0046
OG0052
OG0060
OG0070
OG0080
Title
Denominators
Categories
Title
Measurements
OG00037.5± NASD was not able to be calculated because data is for 1 participant
OG001-22.222± NASD was not able to be calculated because data is for 1 participant