Study Evaluating the Safety and Efficacy of JCARH125 in S... | NCT03430011 | Trialant
NCT03430011
Sponsor
Juno Therapeutics, a Subsidiary of Celgene
Status
Completed
Last Update Posted
May 24, 2024Actual
Enrollment
165Actual
Phase
Phase 1Phase 2
Conditions
Multiple Myeloma
Interventions
JCARH125
JCARH125 + anakinra
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03430011
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
H125001
Secondary IDs
Not provided
Brief Title
Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Official Title
Protocol H125001: An Open-Label Phase 1/2 Study of JCARH125, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory Multiple Myeloma
Acronym
EVOLVE
Organization
Juno Therapeutics, a Subsidiary of CelgeneINDUSTRY
Status Module
Record Verification Date
Apr 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 1, 2018Actual
Primary Completion Date
Mar 30, 2023Actual
Completion Date
Mar 30, 2023Actual
First Submitted Date
Feb 6, 2018
First Submission Date that Met QC Criteria
Feb 9, 2018
First Posted Date
Feb 12, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Mar 28, 2024
Results First Submitted that Met QC Criteria
Apr 29, 2024
Results First Posted Date
May 24, 2024Actual
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
Apr 29, 2024
Last Update Posted Date
May 24, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Juno Therapeutics, a Subsidiary of CelgeneINDUSTRY
Collaborators
Not provided
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose. The safety and tolerability of JCARH125 in subjects who receive prophylactic treatment with anakinra will be evaluated in a separate Phase 1 cohort. The antitumor activity of JCARH125 in subjects who have been previously treated with BCMA-directed therapy will be evaluated in separate Phase 2a cohorts.
Detailed Description
Not provided
Conditions Module
Conditions
Multiple Myeloma
Keywords
JCARH125
chimeric antigen receptor
multiple myeloma
CAR T cells
B-cell maturation antigen
BCMA
autologous T-cell therapy
immunotherapy
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
165Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
JCARH125
Experimental
Subjects will receive a course of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single dose of JCARH125
Biological: JCARH125
JCARH125 + anakinra
Experimental
Subjects will receive a course of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by prophylactic treatment with anakinra and a single dose of JCARH125
Biological: JCARH125 + anakinra
Interventions
Name
Type
Description
Arm Group Labels
Other Names
JCARH125
Biological
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCARH125. During JCARH125 production, participants may receive bridging chemotherapy for disease control. Following successful generation of JCARH125 product, participants will receive a course of lymphodepleting chemotherapy followed by one dose of JCARH125 administered intravenously (IV).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-Limiting Toxicity (DLT) in Phase 1
DLT is defined as adverse events (AEs) that occur within 21 days following JCARH125 infusion and meet any of the following criteria:
Treatment-emergent Grade ≥3 allergic reactions related to JCARH125;
Treatment-emergent Grade 3 seizures, regardless of attribution, that do not resolve to Grade ≤2 within 3 days in participants who have no evidence of central nervous system (CNS) involvement of Multiple Myeloma or other CNS pathology;
Treatment-emergent Grade 3 CRS that does not resolve to Grade ≤2 within 72 hours;
Any other treatment-emergent Grade 3 AE related to JCARH125 that does not resolve to Grade ≤2 within 7 days;
Any treatment-emergent Grade 4 AE related to JCARH125 that does not resolve to Grade ≤2 within 7 days;
Treatment-emergent Grade 4 Cytokine Release Syndrome of any duration;
Any treatment-emergent Grade 5 toxicity not due to the underlying malignancy
From day 1 to day 22 following JCARH125 infusion (Up to 21 days)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity in Phase 1 and Phase 1 Anakinra
TEAE is defined as an AE that starts any time from initiation of JCARH125 administration through and including 90 days following the JCARH125 infusion graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment will not be considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening; and Grade 5=death.
From the time of JCARH125 infusion to 90 days following the infusion (Up to 90 days)
Number of Participants With Clinically Significant Laboratory Abnormalities by Severity in Phase 1 and Phase 1 Anakinra
Clinically significant laboratory abnormalities are assessed by investigator and are reported as treatment-emergent adverse event (TEAE). TEAE is defined as an AE that starts any time from initiation of JCARH125 administration through and including 90 days following the JCARH125 infusion graded by Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment is not considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening.
Secondary Outcomes
Measure
Description
Time Frame
Maximum Observed Concentration (Cmax)
Cmax is the maximal concentration of JCARH125 CAR T cells in the blood after its infusion as determined by quantitative polymerase chain reaction (qPCR) to detect the JCARH125 transgene.
From JCARH125 infusion through the day 29 visit
Time to Maximum Observed Concentration (Tmax)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of multiple myeloma (MM) with relapsed and/or refractory (R/R) disease. Participants must have received at least 3 prior anti-myeloma treatment regimens. Participants must have previously received all of the following therapies and must be refractory to the last line of therapy prior to entering the study (not applicable to Phase 2a):
Autologous stem cell transplant
A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or in combination
Anti-CD38 (eg, daratumumab) as part of a combination regimen or as a monotherapy
Subjects who have received prior allogeneic stem cell transplant or donor lymphocyte infusion at least 100 days before enrollment with no signs of acute or chronic graft-versus-host disease (GVHD) will be considered eligible. Subjects who were not candidates to receive one or more of the above treatments (ie, contraindicated) are eligible.
Subjects must have measurable disease.
Subject must be willing to provide fresh bone marrow biopsy samples during Screening (and prior to study treatment, if required).
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate renal, bone marrow, hepatic, pulmonary, and cardiac function
Phase 2a cohorts only - Subjects with R/R MM who have been previously treated with prior BCMA-directed anti-myeloma therapy, achieved at least a partial response (PR) and progressed on the following treatment:
Subjects who have received prior BCMA-directed CAR T-cell therapy. The last CAR T-cell therapy must have been received at least 6 months prior to JCARH125 screening.
Subjects who have received prior BCMA-directed T-cell engager therapy.
Subjects who have received prior BCMA-directed antibody-drug conjugate therapy.
Exclusion Criteria:
Subjects with known active or history of CNS involvement by malignancy
Subjects with solitary plasmacytoma; active or history of plasma cell leukemia (PCL); Waldenstrom's macroglobulinemia; Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasmaproliferative disorder, Skin changes (POEMS) syndrome; or symptomatic amyloidosis
Subjects who are considered eligible to receive and have not refused an autologous stem cell transplant
History of another primary malignancy that has not been in remission for at least 3 years. The following are exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.
Require systemic immunosuppressive therapies (eg, calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-IL-6 or anti-IL-6 receptor [IL-6R])
Prior CAR T-cell or other genetically-modified T-cell therapy (not applicable for subjects enrolled in Phase 2a cohorts)
Prior treatment with a BCMA-targeted agent (not applicable for subjects enrolled in Phase 2a cohorts)
History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Untreated or active infection at time of initial screening, at the time of leukapheresis, within 72 hrs before lymphodepletion, or 5 days before JCARH125 infusion.
History of any of the following cardiovascular conditions within 6 months of screening: Class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac disease
Subjects with known hypersensitivity to E Coli-derived proteins (only applicable to subjects in Phase 1 Anakinra Cohort)
History of severe immediate hypersensitivity reaction to any of the protocol-mandated or recommended agents used in this study
JCARH125 IV at dose level 50 x 10^6 consisting of CD3+CAR+T cells
FG001
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10^6 consisting of CD3+CAR+T cells
Periods
Title
Milestones
Reasons Not Completed
Pre-Treatment
Type
Comment
Milestone Data
STARTED
Underwent Leukapheresis
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
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
Feb 10, 2020
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
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
JCARH125
JCARH125 + anakinra
Biological
Participants will undergo leukapheresis to isolate PBMCs for the production of JCARH125. During JCARH125 production, participants may receive bridging chemotherapy for disease control. Following successful generation of JCARH125 product, participants will receive a course of lymphodepleting chemotherapy followed by two doses of anakinra administered subcutaneously and one dose of JCARH125 administered IV. Subjects receive anakinra for 5 consecutive days following JCARH125 infusion.
JCARH125 + anakinra
From the time of JCARH125 infusion to 90 days following the infusion (Up to 90 days)
Number of Participants Receiving Prophylactic Anakinra With Grade ≥2 Cytokine Release Syndrome (CRS) in Phase 1 and Phase 1 Anakinra
Number of participants receiving prophylactic anakinra with grade ≥ 2 CRS relative to the number of participants treated at the recommended Phase 2 dose (RP2D) in the Phase 1 dose escalation portion of the trial with grade ≥ 2 CRS. CRS grade is defined by the most severe symptom (excluding fever). Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening
From first infusion to up to aproximately 61 months
Time to Onset of Grade ≥2 Cytokine Release Syndrome (CRS) in Phase 1 and Phase 1 Anakinra
Time to first onset of Grade ≥2 CRS in participants receiving prophylactic anakinra relative to onset of Grade ≥ 2 CRS in participants treated at the RP2D(s) in the Phase 1 dose escalation portion of the trial. Time to onset is calculated from the latest JCARH125 infusion prior to the first onset of Grade >= 2 CRS. CRS grade is defined by the most severe symptom (excluding fever). Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening
From JCARH125 infusion to the first onset of Grade ≥2 CRS (Up to approximately 61 months)
Number of Participants Receiving Prophylactic Anakinra With no Cytokine Release Syndrome (CRS) Occurring on Days 1-3 in Phase 1 Anakinra
The number of participants receiving prophylactic anakinra with no CRS occurring on study days 1, 2, or 3. CRS grade is defined by the most severe symptom (excluding fever). Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening
Day 1, 2, 3
Overall Response Rate (ORR) in Phase 2 and Phase 2a
ORR is defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), according to IMWG criteria. Participants without any reported disease response assessments will be considered non-responders.
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates. When the only method to measure disease is by serum FLC levels, CR can be defined as a normal FLC ratio of 0.26 to 1.65; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level plus urine M-protein level < 100 mg/24 h; PR=≥ 50% reduction of serum M protein plus reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg/24 h
From the time of the JCARH125 infusion until disease progression, end of study, or the start of another anticancer therapy or stem cell transplant (Up to aproximately 61 months)
Tmax is the first study day the maximum observed concetration (Cmax) of JCARH125 CAR T cells in the blood is reached as determined by quantitative polymerase chain reaction (qPCR) to detect the JCARH125 transgene.
From JCARH125 infusion through the day 29 visit
Area Under the Concertation-Time Curve (AUC) From Time Day 1 to Day 29 [AUC (0-28 Days)]
AUC (0-28) of JCARH125 CAR T cells in the blood as determined by quantitative polymerase chain reaction (qPCR) to detect the JCARH125 transgene.
From JCARH125 infusion through 28 days after the infusion
Number of Participants With Pharmacokinetics Persistence
Pharmacokinetics persistence of JCARH125 CAR T cells in the blood as determined by quantitative polymerase chain reaction (qPCR) over time to detect the JCARH125 transgene. Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD).
Day 29, 60, 90, 180, 270, 365, 545, 730
Overall Response Rate (ORR) in Phase 1 and Phase 1 Anakinra
ORR is defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), according to IMWG criteria. Participants without any reported disease response assessments will be considered non-responders.
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates. When the only method to measure disease is by serum FLC levels, CR can be defined as a normal FLC ratio of 0.26 to 1.65; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level plus urine M-protein level < 100 mg/24 h; PR=≥ 50% reduction of serum M protein plus reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg/24 h
From the time of the JCARH125 infusion until disease progression, end of study, or the start of another anticancer therapy or stem cell transplant (Up to 61 approximately months)
Complete Response Rate (CRR)
CRR is defined as stringent complete response (sCR) or complete response (CR), according to IMWG criteria. Participants without any reported disease response assessments will be considered non-responders.
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates
From the time of the JCARH125 infusion until disease progression, end of study, or the start of another anticancer therapy or stem cell transplant (Up to aproximately 61 months)
Duration of Response (DoR) in Phase 2 and 2a
DoR is defined as the time from first response (stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR)) to the earlier date of progressive disease or death due to any cause.
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level plus urine M-protein level < 100 mg/24 h; PR=≥ 50% reduction of serum M protein plus reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg/24 h.
Progressive disease is defined as (1) Increase of ≥25% from lowest confirmed response; (2) Appearance of a new lesion(s); (3) ≥50% increase in circulating plasma cells.
From first response to the date of progression or death due to any cause, whichever occurs first (Up to approixmately 61 months)
Duration of Complete Response (DoCR) in Phase 2 and 2a
DoCR is defined as the time from first response (stringent complete response (sCR), complete response (CR)) to the earlier date of progressive disease or death due to any cause.
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates.
Progressive disease is defined as (1) Increase of ≥25% from lowest confirmed response; (2) Appearance of a new lesion(s); (3) ≥50% increase in circulating plasma cells.
From first response to the date of progression or death due to any cause, whichever occurs first (Up to approixmately 61 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity in Phase 2 and Phase 2a
TEAE is defined as an AE that starts any time from initiation of JCARH125 administration through and including 90 days following the JCARH125 infusion graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment will not be considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening; and Grade 5=death.
From the time of JCARH125 infusion to 90 days following the infusion (Up to 90 days)
Number of Participants With Clinically Significant Laboratory Abnormalities by Severity in Phase 2 and Phase 2a
Clinically significant laboratory abnormalities are assessed by investigator and are reported as treatment-emergent adverse event (TEAE). TEAE is defined as an AE that starts any time from initiation of JCARH125 administration through and including 90 days following the JCARH125 infusion graded by Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment is not considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening.
From the time of JCARH125 infusion to 90 days following the infusion (Up to 90 days)
Overall Survival (OS) in Phase 2 and Phase 2a
OS is defined as the time from the JCARH125 infusion until death due to any cause.
Form date of first infusion to the date of death due to any reason (Up to apprixamtely 61 months)
Progression Free Survival (PFS) in Phase 2 and Phase 2a
PFS is defined as the time from JCARH125 infusion until the earliest date of disease progression or death from any cause. Progressive disease (PD) is defined as (1) Increase of ≥25% from lowest confirmed response in one or more of the following: Serum M-protein absolute increase ≥0.5 g/dL; Serum M-protein increase ≥1 g/dL, if the lowest M component was ≥5 g/dL; Urine M protein absolute increase ≥200 mg/24 h; the difference between involved and uninvolved FLC levels absolute increase >10 mg/dL; Bone marrow plasma-cell percentage irrespective of baseline status absolute increase ≥10%. (2) Appearance of a new lesion(s), ≥50% increase from nadir in SPDd of >1 lesion, or ≥50% increase in the longest diameter of a previous lesion >1 cm in short axis. (3) ≥50% increase in circulating plasma cells (minimum of 200 cells μL) if this is the only measure of disease.
Form date of first infusion to the date of disease progression, or death, due to any reason (Up to approximately 61 months)
Time to Response (TTR) in Phase 2 and Phase 2a
TTR is defined from JCARH125 infusion to the first document of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level plus urine M-protein level < 100 mg/24 h; PR=≥ 50% reduction of serum M protein plus reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg/24 h.
Progressive disease is defined as (1) Increase of ≥25% from lowest confirmed response; (2) Appearance of a new lesion(s); (3) ≥50% increase in circulating plasma cells.
Form date of first infusion to the date of disease progression, or death, due to any reason (Up to approximately 61 months)
Time to Complete Response (TTCR) in Phase 2 and Phase 2a
TTCR is defined from JCARH125 infusion to the first document of stringent complete response (sCR) or complete response (CR).
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates.
Progressive disease is defined as (1) Increase of ≥25% from lowest confirmed response; (2) Appearance of a new lesion(s); (3) ≥50% increase in circulating plasma cells.
Form date of first infusion to the date of disease progression, or death, due to any reason (Up to approximately 61 months)
Change From Baseline in the Total Score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) in Phase 2
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures such as functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Subscale scores are transformed to 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. Baseline is defined as the last non-missing measurement prior to JCARH125 infusion.
Baseline and visit 24 month
Change From Baseline in the Total Score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (QLQ-MY20) in Phase 2
QLQ-MY20 includes 20 questions across four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.
Baseline and visit 24 month
Change From Baseline (EQ-5D-5L) Index Score in Phase 2
EQ-5D-5L is a standardized measure of health status that consists of descriptive system and Visual Analogue scale VAS). The descriptive system comprises dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the dimensions are combined in a 5-digit number corresponding to response categories for successive dimensions using a scoring algorithm. The VAS system has endpoints labeled "the best health you can imagine" and "the worst health you can imagine." The scale is numbered from 0 to 100 with 0 corresponding to the worst imaginable health state and 100 corresponding to the best imaginable health state. A high score represents a better level of quality of life
Baseline and visit 24 month
Duration of Hospitalization From JCARH125 Administration in Phase 2
Total length of all intensive care unit (ICU) and non-ICU stays from JCARH125 Administration. ICU inpatient and non-ICU inpatient are not exclusive. Total length includes participants who had multiple hospitalization stays.
From JCARH125 infusion to up to approximately 61 months
Reasons for Hospitalization From JCARH125 Administration in Phase 2
Number of participants with reasons for hospitalization from JCARH125 administration
From JCARH125 infusion to up to approximately 61 months
Duarte
California
91010
United States
Local Institution - 0059
Los Angeles
California
90095-1678
United States
Local Institution - 0010
San Francisco
California
94158
United States
Local Institution - 0060
Denver
Colorado
80218
United States
Local Institution - 0042
Atlanta
Georgia
30322
United States
Local Institution - 0016
New Lenox
Illinois
60451
United States
Local Institution - 0061
Indianapolis
Indiana
46202
United States
Local Institution - 0053
Westwood
Kansas
66205
United States
Local Institution - 0009
Baltimore
Maryland
21231
United States
Local Institution - 0005
Boston
Massachusetts
02114
United States
Local Institution - 0062
Detroit
Michigan
48201
United States
Local Institution - 0054
Rochester
Minnesota
55905
United States
Local Institution - 0038
Hackensack
New Jersey
07601
United States
Local Institution - 0013
Buffalo
New York
14263
United States
Local Institution - 0001
New York
New York
10065
United States
Local Institution - 0058
Portland
Oregon
97201-3098
United States
Local Institution - 0023
Seattle
Washington
98104
United States
Local Institution - 0018
Seattle
Washington
98109
United States
Local Institution - 0055
Milwaukee
Wisconsin
53226
United States
FG002
Phase 1 300 x 10^6 Cells
JCARH125 IV at dose level 300 x 10^6 consisting of CD3+CAR+T cells
FG003
Phase 1 450 x 10^6 Cells
JCARH125 IV at dose level 450 x 10^6 consisting of CD3+CAR+T cells
FG004
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
FG005
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
FG006
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
FG007
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
FG00015 subjects
FG00130 subjects
FG00227 subjects
FG00322 subjects
FG00422 subjects
FG00514 subjects
FG00625 subjects
FG00710 subjects
Received Lymphodepleting Chemotherapy (LDC)
FG00015 subjects
FG00130 subjects
FG00226 subjects
FG00321 subjects
FG00420 subjects
FG00514 subjects
FG00624 subjects
FG00710 subjects
COMPLETED
Received JCARH125
FG00014 subjects
FG00130 subjects
FG00226 subjects
FG00321 subjects
FG00420 subjects
FG00514 subjects
FG00624 subjects
FG00710 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0042 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Screen Fail
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
No JCARH125 - disease related complications
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Participant not eligible - other reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
JCARH125 Treatment
Type
Comment
Milestone Data
STARTED
Received JCARH125
FG00014 subjects
FG00130 subjects
FG00226 subjects
FG00321 subjects
FG00420 subjects
FG00514 subjects
FG00624 subjects
FG00710 subjects
COMPLETED
FG0008 subjects
FG0019 subjects
FG0027 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0006 subjects
FG00121 subjects
FG00219 subjects
FG00315 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0025 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1 50 x 10^6 Cells
JCARH125 IV at dose level 50 x 10^6 consisting of CD3+CAR+T cells
BG001
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10^6 consisting of CD3+CAR+T cells
BG002
Phase 1 300 x 10^6 Cells
JCARH125 IV at dose level 300 x 10^6 consisting of CD3+CAR+T cells
BG003
Phase 1 450 x 10^6 Cells
JCARH125 IV at dose level 450 x 10^6 consisting of CD3+CAR+T cells
BG004
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
BG005
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
BG006
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
BG007
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00015
BG00130
BG00227
BG00322
BG00422
BG00514
BG00625
BG00710
BG008165
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG00113
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Number of Participants With Dose-Limiting Toxicity (DLT) in Phase 1
DLT is defined as adverse events (AEs) that occur within 21 days following JCARH125 infusion and meet any of the following criteria:
Treatment-emergent Grade ≥3 allergic reactions related to JCARH125;
Treatment-emergent Grade 3 seizures, regardless of attribution, that do not resolve to Grade ≤2 within 3 days in participants who have no evidence of central nervous system (CNS) involvement of Multiple Myeloma or other CNS pathology;
Treatment-emergent Grade 3 CRS that does not resolve to Grade ≤2 within 72 hours;
Any other treatment-emergent Grade 3 AE related to JCARH125 that does not resolve to Grade ≤2 within 7 days;
Any treatment-emergent Grade 4 AE related to JCARH125 that does not resolve to Grade ≤2 within 7 days;
Treatment-emergent Grade 4 Cytokine Release Syndrome of any duration;
Any treatment-emergent Grade 5 toxicity not due to the underlying malignancy
All participants who have either experienced a DLT or were followed for the full DLT evaluation period in phase 1
Posted
Count of Participants
Participants
From day 1 to day 22 following JCARH125 infusion (Up to 21 days)
ID
Title
Description
OG000
Phase 1 50 x 10^6 Cells
JCARH125 IV at dose level 50 x 10^6 consisting of CD3+CAR+T cells
OG001
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10^6 consisting of CD3+CAR+T cells
OG002
Phase 1 300 x 10^6 Cells
JCARH125 IV at dose level 300 x 10^6 consisting of CD3+CAR+T cells
OG003
Phase 1 450 x 10^6 Cells
JCARH125 IV at dose level 450 x 10^6 consisting of CD3+CAR+T cells
OG004
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
Units
Counts
Participants
OG00015
OG00130
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0021
OG003
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity in Phase 1 and Phase 1 Anakinra
TEAE is defined as an AE that starts any time from initiation of JCARH125 administration through and including 90 days following the JCARH125 infusion graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment will not be considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening; and Grade 5=death.
All participants who received at least one infusion of JCARH125 (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) in phase 1 and in phase 1 Anakinra
Posted
Count of Participants
Participants
From the time of JCARH125 infusion to 90 days following the infusion (Up to 90 days)
ID
Title
Description
OG000
Phase 1 50 x 10^6 Cells
JCARH125 IV at dose level 50 x 10^6 consisting of CD3+CAR+T cells
OG001
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10^6 consisting of CD3+CAR+T cells
OG002
Phase 1 300 x 10^6 Cells
JCARH125 IV at dose level 300 x 10^6 consisting of CD3+CAR+T cells
Primary
Number of Participants With Clinically Significant Laboratory Abnormalities by Severity in Phase 1 and Phase 1 Anakinra
Clinically significant laboratory abnormalities are assessed by investigator and are reported as treatment-emergent adverse event (TEAE). TEAE is defined as an AE that starts any time from initiation of JCARH125 administration through and including 90 days following the JCARH125 infusion graded by Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment is not considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening.
All participants who received at least one infusion of JCARH125 (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) in phase 1 and in phase 1 Anakinra
Posted
Count of Participants
Participants
From the time of JCARH125 infusion to 90 days following the infusion (Up to 90 days)
ID
Title
Description
OG000
Phase 1 50 x 10^6 Cells
JCARH125 IV at dose level 50 x 10^6 consisting of CD3+CAR+T cells
OG001
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10^6 consisting of CD3+CAR+T cells
OG002
Phase 1 300 x 10^6 Cells
Primary
Number of Participants Receiving Prophylactic Anakinra With Grade ≥2 Cytokine Release Syndrome (CRS) in Phase 1 and Phase 1 Anakinra
Number of participants receiving prophylactic anakinra with grade ≥ 2 CRS relative to the number of participants treated at the recommended Phase 2 dose (RP2D) in the Phase 1 dose escalation portion of the trial with grade ≥ 2 CRS. CRS grade is defined by the most severe symptom (excluding fever). Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening
All participants who received at least one infusion of JCARH125 (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra), at dose level 600 x 10^6 in phase 1 and in phase 1 Anakinra
Posted
Count of Participants
Participants
From first infusion to up to aproximately 61 months
ID
Title
Description
OG000
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG001
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
Units
Counts
Primary
Time to Onset of Grade ≥2 Cytokine Release Syndrome (CRS) in Phase 1 and Phase 1 Anakinra
Time to first onset of Grade ≥2 CRS in participants receiving prophylactic anakinra relative to onset of Grade ≥ 2 CRS in participants treated at the RP2D(s) in the Phase 1 dose escalation portion of the trial. Time to onset is calculated from the latest JCARH125 infusion prior to the first onset of Grade >= 2 CRS. CRS grade is defined by the most severe symptom (excluding fever). Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening
All participants with grade ≥2 CRS who received at least one infusion of JCARH125 (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) at dose level 600 x 10^6 in phase 1 and in phase 1 Anakinra
Posted
Median
Full Range
Days
From JCARH125 infusion to the first onset of Grade ≥2 CRS (Up to approximately 61 months)
ID
Title
Description
OG000
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG001
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
Units
Primary
Number of Participants Receiving Prophylactic Anakinra With no Cytokine Release Syndrome (CRS) Occurring on Days 1-3 in Phase 1 Anakinra
The number of participants receiving prophylactic anakinra with no CRS occurring on study days 1, 2, or 3. CRS grade is defined by the most severe symptom (excluding fever). Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening
All participants who received at least one infusion of JCARH125 and at least one dose of anakinra as prophylactic intervention in phase 1 Anakinra
Posted
Count of Participants
Participants
Day 1, 2, 3
ID
Title
Description
OG000
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
Units
Counts
Participants
OG000
Primary
Overall Response Rate (ORR) in Phase 2 and Phase 2a
ORR is defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), according to IMWG criteria. Participants without any reported disease response assessments will be considered non-responders.
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates. When the only method to measure disease is by serum FLC levels, CR can be defined as a normal FLC ratio of 0.26 to 1.65; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level plus urine M-protein level < 100 mg/24 h; PR=≥ 50% reduction of serum M protein plus reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg/24 h
All participants who received conforming JCARH125 cell product at the recommended phase 2 dose and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 2 and in phase 2a
Posted
Number
95% Confidence Interval
Percent of participants
From the time of the JCARH125 infusion until disease progression, end of study, or the start of another anticancer therapy or stem cell transplant (Up to aproximately 61 months)
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG001
Secondary
Maximum Observed Concentration (Cmax)
Cmax is the maximal concentration of JCARH125 CAR T cells in the blood after its infusion as determined by quantitative polymerase chain reaction (qPCR) to detect the JCARH125 transgene.
All participants who have the necessary PK measurements to provide interpretable results for this specific parameter of interest
Posted
Geometric Mean
Geometric Coefficient of Variation
Copies/UG
From JCARH125 infusion through the day 29 visit
ID
Title
Description
OG000
Phase 1 50 x 10^6 Cells
JCARH125 IV at dose level 50 x 10^6 consisting of CD3+CAR+T cells
OG001
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10^6 consisting of CD3+CAR+T cells
OG002
Phase 1 300 x 10^6 Cells
JCARH125 IV at dose level 300 x 10^6 consisting of CD3+CAR+T cells
OG003
Phase 1 450 x 10^6 Cells
JCARH125 IV at dose level 450 x 10^6 consisting of CD3+CAR+T cells
Secondary
Time to Maximum Observed Concentration (Tmax)
Tmax is the first study day the maximum observed concetration (Cmax) of JCARH125 CAR T cells in the blood is reached as determined by quantitative polymerase chain reaction (qPCR) to detect the JCARH125 transgene.
All participants who have the necessary PK measurements to provide interpretable results for this specific parameter of interest
Posted
Median
Full Range
Day
From JCARH125 infusion through the day 29 visit
ID
Title
Description
OG000
Phase 1 50 x 10^6 Cells
JCARH125 IV at dose level 50 x 10^6 consisting of CD3+CAR+T cells
OG001
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10^6 consisting of CD3+CAR+T cells
OG002
Phase 1 300 x 10^6 Cells
JCARH125 IV at dose level 300 x 10^6 consisting of CD3+CAR+T cells
OG003
Phase 1 450 x 10^6 Cells
JCARH125 IV at dose level 450 x 10^6 consisting of CD3+CAR+T cells
Secondary
Area Under the Concertation-Time Curve (AUC) From Time Day 1 to Day 29 [AUC (0-28 Days)]
AUC (0-28) of JCARH125 CAR T cells in the blood as determined by quantitative polymerase chain reaction (qPCR) to detect the JCARH125 transgene.
All participants who have the necessary PK measurements to provide interpretable results for this specific parameter of interest
Posted
Geometric Mean
Geometric Coefficient of Variation
Day*copies/UG
From JCARH125 infusion through 28 days after the infusion
ID
Title
Description
OG000
Phase 1 50 x 10^6 Cells
JCARH125 IV at dose level 50 x 10^6 consisting of CD3+CAR+T cells
OG001
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10^6 consisting of CD3+CAR+T cells
OG002
Phase 1 300 x 10^6 Cells
JCARH125 IV at dose level 300 x 10^6 consisting of CD3+CAR+T cells
OG003
Phase 1 450 x 10^6 Cells
JCARH125 IV at dose level 450 x 10^6 consisting of CD3+CAR+T cells
Secondary
Number of Participants With Pharmacokinetics Persistence
Pharmacokinetics persistence of JCARH125 CAR T cells in the blood as determined by quantitative polymerase chain reaction (qPCR) over time to detect the JCARH125 transgene. Persistence is defined as a transgene count greater than or equal to the lower limit of detection (LLOD).
All participants who have the necessary PK measurements to provide interpretable results for the specific parameters of interest
Posted
Count of Participants
Participants
Day 29, 60, 90, 180, 270, 365, 545, 730
ID
Title
Description
OG000
Phase 1 50 x 10^6 Cells
JCARH125 IV at dose level 50 x 10^6 consisting of CD3+CAR+T cells
OG001
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10^6 consisting of CD3+CAR+T cells
OG002
Phase 1 300 x 10^6 Cells
JCARH125 IV at dose level 300 x 10^6 consisting of CD3+CAR+T cells
OG003
Phase 1 450 x 10^6 Cells
JCARH125 IV at dose level 450 x 10^6 consisting of CD3+CAR+T cells
Secondary
Overall Response Rate (ORR) in Phase 1 and Phase 1 Anakinra
ORR is defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), according to IMWG criteria. Participants without any reported disease response assessments will be considered non-responders.
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates. When the only method to measure disease is by serum FLC levels, CR can be defined as a normal FLC ratio of 0.26 to 1.65; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level plus urine M-protein level < 100 mg/24 h; PR=≥ 50% reduction of serum M protein plus reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg/24 h
All participants who received conforming JCARH125 cell product at the recommended phase 2 dose (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 1 and in phase 1 Anakinra
Posted
Number
95% Confidence Interval
Percent of participants
From the time of the JCARH125 infusion until disease progression, end of study, or the start of another anticancer therapy or stem cell transplant (Up to 61 approximately months)
ID
Title
Description
OG000
Phase 1 50 x 10^6 Cells
JCARH125 IV at dose level 50 x 10^6 consisting of CD3+CAR+T cells
Secondary
Complete Response Rate (CRR)
CRR is defined as stringent complete response (sCR) or complete response (CR), according to IMWG criteria. Participants without any reported disease response assessments will be considered non-responders.
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates
All participants who received conforming JCARH125 cell product at the recommended phase 2 dose (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion
Posted
Number
95% Confidence Interval
Percent of participants
From the time of the JCARH125 infusion until disease progression, end of study, or the start of another anticancer therapy or stem cell transplant (Up to aproximately 61 months)
ID
Title
Description
OG000
Phase 1 50 x 10^6 Cells
JCARH125 IV at dose level 50 x 10^6 consisting of CD3+CAR+T cells
OG001
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10^6 consisting of CD3+CAR+T cells
OG002
Phase 1 300 x 10^6 Cells
Secondary
Duration of Response (DoR) in Phase 2 and 2a
DoR is defined as the time from first response (stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR)) to the earlier date of progressive disease or death due to any cause.
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level plus urine M-protein level < 100 mg/24 h; PR=≥ 50% reduction of serum M protein plus reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg/24 h.
Progressive disease is defined as (1) Increase of ≥25% from lowest confirmed response; (2) Appearance of a new lesion(s); (3) ≥50% increase in circulating plasma cells.
All participants with sCR, CR, VGPR, or PR who received conforming JCARH125 cell product at the recommended phase 2 dose and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 2 and in phase 2a
Posted
Median
Full Range
Months
From first response to the date of progression or death due to any cause, whichever occurs first (Up to approixmately 61 months)
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG001
Secondary
Duration of Complete Response (DoCR) in Phase 2 and 2a
DoCR is defined as the time from first response (stringent complete response (sCR), complete response (CR)) to the earlier date of progressive disease or death due to any cause.
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates.
Progressive disease is defined as (1) Increase of ≥25% from lowest confirmed response; (2) Appearance of a new lesion(s); (3) ≥50% increase in circulating plasma cells.
All participants with sCR or CR who received conforming JCARH125 cell product at the recommended phase 2 dose and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 2 and in phase 2a
Posted
Median
Full Range
Months
From first response to the date of progression or death due to any cause, whichever occurs first (Up to approixmately 61 months)
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG001
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity in Phase 2 and Phase 2a
TEAE is defined as an AE that starts any time from initiation of JCARH125 administration through and including 90 days following the JCARH125 infusion graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment will not be considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening; and Grade 5=death.
All participants who received at least one infusion of JCARH125 in phase 2 and in phase 2a
Posted
Count of Participants
Participants
From the time of JCARH125 infusion to 90 days following the infusion (Up to 90 days)
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG001
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Units
Counts
Participants
Secondary
Number of Participants With Clinically Significant Laboratory Abnormalities by Severity in Phase 2 and Phase 2a
Clinically significant laboratory abnormalities are assessed by investigator and are reported as treatment-emergent adverse event (TEAE). TEAE is defined as an AE that starts any time from initiation of JCARH125 administration through and including 90 days following the JCARH125 infusion graded by Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment is not considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening.
All participants who received at least one infusion of JCARH125 in phase 2 and in phase 2a
Posted
Count of Participants
Participants
From the time of JCARH125 infusion to 90 days following the infusion (Up to 90 days)
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG001
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Units
Counts
Secondary
Overall Survival (OS) in Phase 2 and Phase 2a
OS is defined as the time from the JCARH125 infusion until death due to any cause.
All participants who received conforming JCARH125 cell product at the recommended phase 2 dose and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 2 and in phase 2a
Posted
Median
95% Confidence Interval
Months
Form date of first infusion to the date of death due to any reason (Up to apprixamtely 61 months)
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG001
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Units
Counts
Participants
OG000
Secondary
Progression Free Survival (PFS) in Phase 2 and Phase 2a
PFS is defined as the time from JCARH125 infusion until the earliest date of disease progression or death from any cause. Progressive disease (PD) is defined as (1) Increase of ≥25% from lowest confirmed response in one or more of the following: Serum M-protein absolute increase ≥0.5 g/dL; Serum M-protein increase ≥1 g/dL, if the lowest M component was ≥5 g/dL; Urine M protein absolute increase ≥200 mg/24 h; the difference between involved and uninvolved FLC levels absolute increase >10 mg/dL; Bone marrow plasma-cell percentage irrespective of baseline status absolute increase ≥10%. (2) Appearance of a new lesion(s), ≥50% increase from nadir in SPDd of >1 lesion, or ≥50% increase in the longest diameter of a previous lesion >1 cm in short axis. (3) ≥50% increase in circulating plasma cells (minimum of 200 cells μL) if this is the only measure of disease.
All participants who received conforming JCARH125 cell product at the recommended phase 2 dose and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 2 and in phase 2a
Posted
Median
95% Confidence Interval
Months
Form date of first infusion to the date of disease progression, or death, due to any reason (Up to approximately 61 months)
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG001
Phase 2a 600 x 10^6 Cells Anti-BCMA
Secondary
Time to Response (TTR) in Phase 2 and Phase 2a
TTR is defined from JCARH125 infusion to the first document of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level plus urine M-protein level < 100 mg/24 h; PR=≥ 50% reduction of serum M protein plus reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg/24 h.
Progressive disease is defined as (1) Increase of ≥25% from lowest confirmed response; (2) Appearance of a new lesion(s); (3) ≥50% increase in circulating plasma cells.
All participants with sCR, CR, VGPR, or PR who received conforming JCARH125 cell product at the recommended phase 2 dose and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 2 and in phase 2a
Posted
Median
Full Range
Months
Form date of first infusion to the date of disease progression, or death, due to any reason (Up to approximately 61 months)
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG001
Phase 2a 600 x 10^6 Cells Anti-BCMA
Secondary
Time to Complete Response (TTCR) in Phase 2 and Phase 2a
TTCR is defined from JCARH125 infusion to the first document of stringent complete response (sCR) or complete response (CR).
sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates.
Progressive disease is defined as (1) Increase of ≥25% from lowest confirmed response; (2) Appearance of a new lesion(s); (3) ≥50% increase in circulating plasma cells.
All participants with sCR or CR who received conforming JCARH125 cell product at the recommended phase 2 dose and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 2 and in phase 2a
Posted
Median
Full Range
Months
Form date of first infusion to the date of disease progression, or death, due to any reason (Up to approximately 61 months)
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG001
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Secondary
Change From Baseline in the Total Score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) in Phase 2
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures such as functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Subscale scores are transformed to 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. Baseline is defined as the last non-missing measurement prior to JCARH125 infusion.
All participants who received at least one infusion of JCARH125 with baseline and post-baseline assessment at the respective visit in phase 2 only as prespecified in the protocol
Posted
Mean
Standard Deviation
Score on a Scale
Baseline and visit 24 month
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
Units
Counts
Participants
Secondary
Change From Baseline in the Total Score of European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (QLQ-MY20) in Phase 2
QLQ-MY20 includes 20 questions across four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.
All participants who received at least one infusion of JCARH125 with baseline and post-baseline assessment at the respective visit in phase 2 only as prespecified in the protocol
Posted
Mean
Standard Deviation
Score on a Scale
Baseline and visit 24 month
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
Units
Counts
Participants
OG000
Secondary
Change From Baseline (EQ-5D-5L) Index Score in Phase 2
EQ-5D-5L is a standardized measure of health status that consists of descriptive system and Visual Analogue scale VAS). The descriptive system comprises dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the dimensions are combined in a 5-digit number corresponding to response categories for successive dimensions using a scoring algorithm. The VAS system has endpoints labeled "the best health you can imagine" and "the worst health you can imagine." The scale is numbered from 0 to 100 with 0 corresponding to the worst imaginable health state and 100 corresponding to the best imaginable health state. A high score represents a better level of quality of life
All participants who received at least one infusion of JCARH125 with baseline and post-baseline assessment at the respective visit in phase 2 only as prespecified in the protocol
Posted
Mean
Standard Deviation
Score on a scale
Baseline and visit 24 month
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
Units
Counts
Secondary
Duration of Hospitalization From JCARH125 Administration in Phase 2
Total length of all intensive care unit (ICU) and non-ICU stays from JCARH125 Administration. ICU inpatient and non-ICU inpatient are not exclusive. Total length includes participants who had multiple hospitalization stays.
All participants who received at least one infusion of JCARH125 with baseline and post-baseline assessment at the respective visit in phase 2 only as prespecified in the protocol
Posted
Median
Full Range
Days
From JCARH125 infusion to up to approximately 61 months
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
Units
Counts
Participants
OG000
Secondary
Reasons for Hospitalization From JCARH125 Administration in Phase 2
Number of participants with reasons for hospitalization from JCARH125 administration
All participants who received at least one infusion of JCARH125 with baseline and post-baseline assessment at the respective visit in phase 2 only as prespecified in the protocol
Posted
Count of Participants
Participants
From JCARH125 infusion to up to approximately 61 months
ID
Title
Description
OG000
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
Units
Counts
Participants
OG000
Time Frame
Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until their study completion (up to approximately 61 months). SAEs and other AEs were assessed from first JCARH125 infusion until 90 days following the JCARH125 infusion (up to approximately 41 months).
Description
The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 infusion of study medication (JCARH125).
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 1 50 x 10^6 Cells
JCARH125 IV at dose level 50 x 10^6 consisting of CD3+CAR+T cells
5
15
1
14
14
14
EG001
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10^6 consisting of CD3+CAR+T cells
22
30
14
30
30
30
EG002
Phase 1 300 x 10^6 Cells
JCARH125 IV at dose level 300 x 10^6 consisting of CD3+CAR+T cells
14
27
7
26
26
26
EG003
Phase 1 450 x 10^6 Cells
JCARH125 IV at dose level 450 x 10^6 consisting of CD3+CAR+T cells
9
22
7
21
21
21
EG004
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
7
22
7
20
20
20
EG005
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
4
14
5
14
14
14
EG006
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
6
25
11
24
24
24
EG007
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
2
10
1
10
10
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG0030 affected21 at risk
EG0041 affected20 at risk
EG0050 affected14 at risk
EG0060 affected24 at risk
EG0070 affected10 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0012 affected30 at risk
EG0021 affected26 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0021 affected26 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0012 affected30 at risk
EG0021 affected26 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0013 affected30 at risk
EG0021 affected26 at risk
EG003
Atrial fibrillation
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Pericardial effusion
Cardiac disorders
26.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Pericarditis
Cardiac disorders
26.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
General physical health deterioration
General disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Pyrexia
General disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Cholecystitis
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Cytokine release syndrome
Immune system disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0023 affected26 at risk
EG003
Haemophagocytic lymphohistiocytosis
Immune system disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0021 affected26 at risk
EG003
Appendicitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Bronchitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
COVID-19
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Campylobacter infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Cellulitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Cystitis viral
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0021 affected26 at risk
EG003
Cytomegalovirus chorioretinitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Cytomegalovirus infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0021 affected26 at risk
EG003
Escherichia bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0021 affected26 at risk
EG003
Gastroenteritis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0021 affected26 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Mastoiditis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Metapneumovirus infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Osteomyelitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Otitis externa
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Pneumonia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0013 affected30 at risk
EG0020 affected26 at risk
EG003
Pneumonia aspiration
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Rhinovirus infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Sepsis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Septic shock
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Skin infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Aspartate aminotransferase increased
Investigations
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0021 affected26 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0022 affected26 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected30 at risk
EG0020 affected26 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected30 at risk
EG0020 affected26 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
JCARH125 IV at dose level 450 x 10^6 consisting of CD3+CAR+T cells
OG004
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG005
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
Units
Counts
Participants
OG00014
OG00130
OG00226
OG00321
OG00420
OG00514
Title
Denominators
Categories
TEAE
Title
Measurements
OG00014
OG00130
OG00226
OG00321
OG00420
OG00514
Grade 3-5 TEAE
Title
Measurements
OG00014
OG00130
OG00225
OG003
Grade 5 TEAE
Title
Measurements
OG0000
OG0011
OG0021
OG003
JCARH125-Related TEAE
Title
Measurements
OG00012
OG00126
OG00225
OG003
JCARH125-Related Grade 3-5 TEAE
Title
Measurements
OG0005
OG00110
OG00215
OG003
JCARH125-Related Grade 5 TEAE
Title
Measurements
OG0000
OG0010
OG0020
OG003
JCARH125 IV at dose level 300 x 10^6 consisting of CD3+CAR+T cells
OG003
Phase 1 450 x 10^6 Cells
JCARH125 IV at dose level 450 x 10^6 consisting of CD3+CAR+T cells
OG004
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG005
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
Units
Counts
Participants
OG00014
OG00130
OG00226
OG00321
OG00420
OG00514
Title
Denominators
Categories
Neutropenia grade 3
Title
Measurements
OG0004
OG0011
OG0022
OG0031
OG0043
OG0051
Neutropenia grade 4
Title
Measurements
OG00010
OG00128
OG00222
OG003
Anemia grade 3
Title
Measurements
OG0009
OG00119
OG00216
OG003
Thrombocytopenia grade 3
Title
Measurements
OG0000
OG0014
OG0023
OG003
Thrombocytopenia grade 4
Title
Measurements
OG0004
OG00115
OG00211
OG003
Leukopenia grade 3
Title
Measurements
OG0000
OG0010
OG0022
OG003
Leukopenia grade 4
Title
Measurements
OG0004
OG0018
OG00212
OG003
Lymphopenia grade 3
Title
Measurements
OG0001
OG0012
OG0024
OG003
Lymphopenia grade 4
Title
Measurements
OG0000
OG0011
OG0022
OG003
Febrile neutropenia grade 3
Title
Measurements
OG0001
OG0017
OG0022
OG003
Febrile neutropenia grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haemolysis grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypofibrinogenaemia grade 3
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hypophosphataemia grade 3
Title
Measurements
OG0001
OG0015
OG0022
OG003
Hypophosphataemia grade 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypocalcaemia grade 3
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hypocalcaemia grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypokalaemia grade 3
Title
Measurements
OG0000
OG0013
OG0020
OG003
Hyponatraemia grade 3
Title
Measurements
OG0001
OG0011
OG0022
OG003
Hypomagnesaemia grade 3
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hyperglycaemia grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyperglycaemia grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypoalbuminaemia grade 3
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypertriglyceridaemia grade 3
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypertriglyceridaemia grade 4
Title
Measurements
OG0000
OG0011
OG0020
OG003
Alanine aminotransferase increased grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
Aspartate aminotransferase increased grade 3
Title
Measurements
OG0000
OG0012
OG0020
OG003
Aspartate aminotransferase increased grade 4
Title
Measurements
OG0001
OG0011
OG0020
OG003
Blood alkaline phosphatase increased grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood bilirubin increased grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Serum ferritin increased grade 3
Title
Measurements
OG0000
OG0011
OG0021
OG003
Participants
OG00020
OG00114
Title
Denominators
Categories
Title
Measurements
OG00011
OG0014
Counts
Participants
OG00011
OG0014
Title
Denominators
Categories
Title
Measurements
OG0002.0(1 to 3)
OG0012.0(2 to 3)
14
Title
Denominators
Categories
Title
Measurements
OG0002
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Units
Counts
Participants
OG00024
OG00110
Title
Denominators
Categories
Title
Measurements
OG00091.7(73.0 to 99.0)
OG001100.0(69.2 to 100.0)
OG004
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG005
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG006
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG007
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Units
Counts
Participants
OG00014
OG00130
OG00226
OG00321
OG00420
OG00514
OG00624
OG00710
Title
Denominators
Categories
Title
Measurements
OG00061037.57± 365.26
OG00164705.82± 305.31
OG002123460.33± 156.23
OG003122228.99± 174.22
OG004162706.00± 83.19
OG005176233.64± 99.44
OG006140331.08± 234.07
OG007103009.98± 128.25
OG004
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG005
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG006
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG007
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Units
Counts
Participants
OG00014
OG00130
OG00226
OG00321
OG00420
OG00514
OG00624
OG00710
Title
Denominators
Categories
Title
Measurements
OG00013.50(7.0 to 28.0)
OG00111.00(4.0 to 22.0)
OG00210.00(3.0 to 21.0)
OG00310.00(7.0 to 25.0)
OG00410.00(3.0 to 23.0)
OG00513.50(7.0 to 28.0)
OG0069.50(4.0 to 22.0)
OG00714.50(7.0 to 21.0)
OG004
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG005
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG006
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG007
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Units
Counts
Participants
OG00013
OG00130
OG00226
OG00320
OG00420
OG00513
OG00623
OG00710
Title
Denominators
Categories
Title
Measurements
OG000556080.86± 288.83
OG001610142.64± 276.50
OG0021307054.13± 159.86
OG0031390556.32± 188.93
OG0041956613.78± 80.39
OG0052052280.38± 104.12
OG0061427277.29± 226.53
OG0071287032.03± 145.22
OG004
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG005
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG006
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG007
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Units
Counts
Participants
OG00014
OG00130
OG00226
OG00320
OG00417
OG00514
OG00623
OG00710
Title
Denominators
Categories
Day 29
ParticipantsOG00014
ParticipantsOG00130
ParticipantsOG00226
ParticipantsOG00320
ParticipantsOG00417
ParticipantsOG00514
ParticipantsOG00623
ParticipantsOG00710
Title
Measurements
OG00014
OG00129
OG00226
OG003
Day 60
ParticipantsOG00012
ParticipantsOG00130
ParticipantsOG00225
ParticipantsOG00317
Day 90
ParticipantsOG00013
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00319
Day 180
ParticipantsOG0009
ParticipantsOG00118
ParticipantsOG00221
ParticipantsOG00316
Day 270
ParticipantsOG0007
ParticipantsOG0019
ParticipantsOG00214
ParticipantsOG0038
Day 365
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG00310
Day 545
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Day 730
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0033
OG001
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10^6 consisting of CD3+CAR+T cells
OG002
Phase 1 300 x 10^6 Cells
JCARH125 IV at dose level 300 x 10^6 consisting of CD3+CAR+T cells
OG003
Phase 1 450 x 10^6 Cells
JCARH125 IV at dose level 450 x 10^6 consisting of CD3+CAR+T cells
OG004
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG005
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
Units
Counts
Participants
OG00014
OG00130
OG00226
OG00320
OG00420
OG00514
Title
Denominators
Categories
Title
Measurements
OG00078.6(49.2 to 95.3)
OG00186.7(69.3 to 96.2)
OG00296.2(80.4 to 99.9)
OG00390.0(68.3 to 98.8)
OG004100.0(83.2 to 100.0)
OG005100.0(76.8 to 100.0)
JCARH125 IV at dose level 300 x 10^6 consisting of CD3+CAR+T cells
OG003
Phase 1 450 x 10^6 Cells
JCARH125 IV at dose level 450 x 10^6 consisting of CD3+CAR+T cells
OG004
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG005
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells
OG006
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells expansion
OG007
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Units
Counts
Participants
OG00014
OG00130
OG00226
OG00320
OG00420
OG00514
OG00624
OG00710
Title
Denominators
Categories
Title
Measurements
OG00042.9(17.7 to 71.1)
OG00133.3(17.3 to 52.8)
OG00246.2(26.6 to 66.6)
OG00345.0(23.1 to 68.5)
OG00465.0(40.8 to 84.6)
OG00535.7(12.8 to 64.9)
OG00654.2(32.8 to 74.4)
OG00740.0(12.2 to 73.8)
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Units
Counts
Participants
OG00022
OG00110
Title
Denominators
Categories
Title
Measurements
OG00018.2(2 to 23)
OG00110.1(1 to 23)
Units
Counts
Participants
OG00013
OG0014
Title
Denominators
Categories
Title
Measurements
OG00018.2(0 to 23)
OG00110.8(3 to 23)
OG00024
OG00110
Title
Denominators
Categories
TEAE
Title
Measurements
OG00024
OG00110
Grade 3-5 TEAE
Title
Measurements
OG00023
OG0019
Grade 5 TEAE
Title
Measurements
OG0002
OG0010
JCARH125-Related TEAE
Title
Measurements
OG00023
OG0018
JCARH125-Related Grade 3-5 TEAE
Title
Measurements
OG00016
OG0017
JCARH125-Related Grade 5 TEAE
Title
Measurements
OG0001
OG0010
Participants
OG00024
OG00110
Title
Denominators
Categories
Neutropenia grade 3
Title
Measurements
OG0003
OG0011
Neutropenia grade 4
Title
Measurements
OG00018
OG0016
Anemia grade 3
Title
Measurements
OG00011
OG0013
Thrombocytopenia grade 3
Title
Measurements
OG0003
OG0010
Thrombocytopenia grade 4
Title
Measurements
OG00010
OG0013
Leukopenia grade 3
Title
Measurements
OG0001
OG0010
Leukopenia grade 4
Title
Measurements
OG0008
OG0011
Lymphopenia grade 3
Title
Measurements
OG0001
OG0010
Lymphopenia grade 4
Title
Measurements
OG0003
OG0010
Febrile neutropenia grade 3
Title
Measurements
OG0001
OG0010
Hypophosphataemia grade 3
Title
Measurements
OG0006
OG0011
Hypocalcaemia grade 3
Title
Measurements
OG0003
OG0010
Hypocalcaemia grade 4
Title
Measurements
OG0001
OG0010
Hypokalaemia grade 3
Title
Measurements
OG0002
OG0010
Hyponatraemia grade 3
Title
Measurements
OG0002
OG0010
Hyperglycaemia grade 3
Title
Measurements
OG0002
OG0010
Hypertriglyceridaemia grade 3
Title
Measurements
OG0003
OG0010
Lactic acidosis grade 3
Title
Measurements
OG0001
OG0010
Alanine aminotransferase increased grade 4
Title
Measurements
OG0001
OG0010
Aspartate aminotransferase increased grade 3
Title
Measurements
OG0001
OG0010
Aspartate aminotransferase increased grade 4
Title
Measurements
OG0001
OG0010
Blood fibrinogen decreased grade 3
Title
Measurements
OG0001
OG0010
Blood fibrinogen decreased grade 4
Title
Measurements
OG0001
OG0010
CD4 lymphocytes decreased grade 3
Title
Measurements
OG0001
OG0010
24
OG00110
Title
Denominators
Categories
Title
Measurements
OG000NA(8.71 to NA)insufficient number of participants with events
OG001NA(7.62 to NA)insufficient number of participants with events
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
Units
Counts
Participants
OG00024
OG00110
Title
Denominators
Categories
Title
Measurements
OG00014.75(5.85 to 23.82)
OG00112.25(3.25 to 17.94)
JCARH125 IV at dose level 600 x 10^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy