PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14)
NCT ID: NCT04142359
Last Updated: 2024-12-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
1 participants
OBSERVATIONAL
2019-12-09
2020-04-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
QUILT-2.005 is a phase 2b, randomized, two-cohort, open-label, multicenter study of intravesical ALT-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC. Patients will be enrolled into one of two study cohorts and randomized into two arms to be treated with either ALT-803 plus BCG or BCG alone. Cohort A will initially enroll 366 patients who have histologically confirmed CIS (with or without Ta/T1 papillary disease). Cohort B will initially enroll 230 patients who have histologically confirmed high-grade papillary Ta/T1 disease only. Cohorts A and B are two independent study cohorts and will be evaluated separately for efficacy.
PK sub-study: Blood samples to determine serum levels of ALT-803 will be collected on study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6. Six subjects from either cohort A (either study) or cohort C (QUILT 3.032) and six subjects from cohort B (either study) will be sampled initially. Up to an additional 4 subjects for each cohort may also be sampled. Patients enrolled in QUILT 2.005 must have been randomized to receive ALT-803 plus BCG to be eligible for the PK sub-study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A: CIS (either study)
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
BCG in Combination with N-803
BCG in Combination with N-803
Cohort B: High-Grade Ta/T1 Papillary Disease (either study)
Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease
BCG in Combination with N-803
BCG in Combination with N-803
Cohort C: CIS (QUILT-3.032)
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
N-803 alone
N-803 alone
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BCG in Combination with N-803
BCG in Combination with N-803
N-803 alone
N-803 alone
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients enrolled in QUILT-2.005 must have been randomized to receive ALT-803 plus BCG to participate in this sub-study.
Exclusion Criteria
* Loss of ≥ 475 mL blood volume or blood transfusion of any blood product within 3 months prior to screening.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Altor BioScience
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chad Garner, PhD
Role: STUDY_DIRECTOR
ImmunityBio, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA Department of Urology
Los Angeles, California, United States
University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Adult & Pediatric Urology
Omaha, Nebraska, United States
NYU Winthrop University Hospital Department of Urology
Garden City, New York, United States
Manhattan Medical Research
New York, New York, United States
Virginia Urology
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QUILT-3.032-2.005-PK
Identifier Type: -
Identifier Source: org_study_id