QUILT-1.004: A Single Center, Open-label, Pharmacokinetic... | NCT03381586

NCT03381586

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Group A	Experimental	1.0 mg/ml ALT-803	Drug: ALT-803
Group B	Experimental	2.0 mg/ml ALT-803	Drug: ALT-803

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALT-803	Drug	Subjects randomized to Group A will receive ALT-803 at a concentration of 1.0 mg/mL and subjects randomized to Group B will receive ALT-803 at a concentration of 2.0 mg/mL. Subjects will receive a single 10 µg/kg subQ dose of ALT-803 on Day 1 of study period 1. After a rest period, subjects will receive a single 20 µg/kg subQ dose of ALT-803 on Day 1 of study period 2.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PK Profile - Half-life (t½)	The period of time required for the concentration or amount of drug in the body to be reduced by one-half.	Up to 192 hours
PK Profile - Apparent (Extravascular) Volume of Distribution (Vz/F)	Apparent volume of distribution is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration.	Up to 192 hours
PK Profile - Apparent (Extravascular) Clearance (CL/F)	apparent (extravascular) clearance (CL/F)	Up to 192 hours
PK Profile - Maximum Observed Concentration (Cmax)	maximum observed concentration (Cmax)	Up to 192 hours
PK Profile - Time of the Observed Maximum Concentration (Tmax)	time of the observed maximum concentration (Tmax)	Up to 192 hours
PK Profile - Area Under the Plasma Concentration Curve From Time 0 Through the Last Measurable Concentration (AUC0-t)	area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t)	Up to 192 hours
PK Profile - Area Under the Plasma Concentration Curve From Time 0 Extrapolated to Infinite Time (AUC0-inf)	area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf)

Measure	Description	Time Frame
Number of Adverse Events	Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03	Up to 66 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed Written Informed Consent
1. Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of subject care.
2. Subjects must be willing and able to comply with the scheduled visits, study drug dosing schedule, procedures, laboratory tests, and other requirements of the study.
Study Population
1. Body mass index (BMI) must be within the range of 18 to 28 kg/m2. Subjects must weigh between 50 and 100 kg (inclusive).
2. Subjects must be in good health as determined by past medical history, complete physical examination, vital signs and laboratory tests at screening.
Age and Reproductive Status
1. Men and women, 18 - 65 years of age.
2. Female participants of childbearing potential must adhere to using a medically accepted method of birth control up to 28 days prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) WOCBP must agree to use effective contraception during the study and for at least 1 month following the last dose of the study drug.
3. WOCBP must have a negative serum pregnancy test < 14 days prior to first dose of the study drug. Non-childbearing is defined as greater than one year postmenopausal or surgically sterilized.
4. Male subjects must be willing to use barrier contraception (i.e. condoms and spermicide) from the day of dosing until at least 1 month following the last dose of study drug.

Exclusion Criteria:

Medical History and Concurrent Diseases
1. A past medical history of clinically significant 12 lead EKG abnormalities
2. Subjects with a history of interstitial lung disease and/or pneumonitis.
3. HIV-positive.
4. Significant illness within 2 weeks prior to dosing.
5. Positive hepatitis C serology or active hepatitis B infection.
6. Known autoimmune disease requiring active treatment. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks or 5 half-lives of registration are excluded.
7. Psychiatric illness/social situations that would limit compliance with study requirements.
8. Previous malignancies, unless basal or squamous cell carcinoma of the skin or cervical carcinoma in situ with a complete remission achieved at least 5 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
9. Loss of ≥ 475 mL blood volume or blood donation transfusion of any blood product within 3 months prior to screening.
10. Other illness or laboratory abnormality that in the opinion of the Investigator should exclude the subject from participating in this study.
Prohibited Treatments and/or Restricted Therapies
1. Use of any prescription drugs within 4 weeks (hormonal methods of contraception are allowed) or less than 5 half-lives prior to dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within 2 weeks or less than 5 half-lives prior to dosing.
2. Exposure to any investigational drug or placebo within 3 months of first dose of study drug.
3. Previous treatment or clinical trial participation with monoclonal antibody therapy.
4. History of drug or alcohol abuse within 12 months prior to dosing, or those who have a positive urine drug test or breath alcohol test at Screening or Baseline.
5. Transfusion of blood or any blood product within 3 months prior to screening.
6. History of using nicotine-containing products or smoking more than 5 cigarettes weekly for at least three months prior to the study through the final evaluation.
Allergies and Adverse Drug Reaction
1. History of severe hypersensitivity reactions to other monoclonal antibodies.
2. Known history of clinically significant drug allergy at Screening or Baseline
Sex and Reproductive Status a. Women who are pregnant or nursing.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Quotient Sciences		Miami	Florida	33126	United States

References Module

Label	URL
Related Info	View source

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Group A	1.0 mg/ml ALT-803 ALT-803: Subjects randomized to Group A will receive ALT-803 at a concentration of 1.0 mg/mL. Subjects will receive a single 10 µg/kg subQ dose of ALT-803 on Day 1 of study period 1. After a rest period, subjects will receive a single 20 µg/kg subQ dose of ALT-803 on Day 1 of study period 2.
FG001	Group B	2.0 mg/ml ALT-803 ALT-803: Subjects randomized to Group B will receive ALT-803 at a concentration of 2.0 mg/mL. Subjects will receive a single 10 µg/kg subQ dose of ALT-803 on Day 1 of study period 1. After a rest period, subjects will receive a single 20 µg/kg subQ dose of ALT-803 on Day 1 of study period 2.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00010 subjects FG00110 subjects
COMPLETED		FG0007 subjects FG0017 subjects
NOT COMPLETED		FG0003 subjects FG0013 subjects

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0011 subjects
Protocol Violation		FG0001 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Group A	1.0 mg/ml ALT-803 ALT-803: Subjects randomized to Group A will receive ALT-803 at a concentration of 1.0 mg/mL. Subjects will receive a single 10 µg/kg subQ dose of ALT-803 on Day 1 of study period 1. After a rest period, subjects will receive a single 20 µg/kg subQ dose of ALT-803 on Day 1 of study period 2.
BG001

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

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

PK Profile - Half-life (t½)

The period of time required for the concentration or amount of drug in the body to be reduced by one-half.

Posted

Mean

Standard Deviation

Days

Up to 192 hours

ID	Title	Description
OG000	Group A	1.0 mg/ml ALT-803 ALT-803: Subjects randomized to Group A will receive ALT-803 at a concentration of 1.0 mg/mL. Subjects will receive a single 10 µg/kg subQ dose of ALT-803 on Day 1 of study period 1. After a rest period, subjects will receive a single 20 µg/kg subQ dose of ALT-803 on Day 1 of study period 2.
OG001	Group B	2.0 mg/ml ALT-803 ALT-803: Subjects randomized to Group B will receive ALT-803 at a concentration of 2.0 mg/mL. Subjects will receive a single 10 µg/kg subQ dose of ALT-803 on Day 1 of study period 1. After a rest period, subjects will receive a single 20 µg/kg subQ dose of ALT-803 on Day 1 of study period 2.

Adverse Events Module

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	Group A	1.0 mg/ml ALT-803 ALT-803: Subjects randomized to Group A will receive ALT-803 at a concentration of 1.0 mg/mL. Subjects will receive a single 10 µg/kg subQ dose of ALT-803 on Day 1 of study period 1. After a rest period, subjects will receive a single 20 µg/kg subQ dose of ALT-803 on Day 1 of study period 2.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Sandeep Bobby Reddy, Chief Medical Officer	ImmunityBio	855-797-9277		Bobby.Reddy@Immunitybio.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 9, 2017	Feb 24, 2025	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Mar 12, 2019	Mar 19, 2025	SAP_001.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

ID	Term
C582303	ALT-803

Masking Info

EG0003 affected10 at risk

EG0013 affected10 at risk

OG0010.583(0.167 to 2.00)