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NCT04981119 · ClinicalTrials.gov registry record
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
A clinical trial of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by A2 Biotherapeutics.
- Recruiting
- Registry status
- 200
- Enrollment target
- 16
- Study locations
NCT04981119 is a study of Non-Small Cell Lung Cancer and Colorectal Cancer that is actively recruiting participants, run by A2 Biotherapeutics. The registered enrollment target is 200 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (70% lower). The trial reports 16 study locations across 11 states.
The verdict
NCT04981119, a study of Non-Small Cell Lung Cancer and Colorectal Cancer, is actively recruiting participants, sponsored by A2 Biotherapeutics.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 16
- Study locations
Study Summary
Objective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Design: This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.
Conditions Studied
Interventions
- OTHER Apheresis
- DIAGNOSTIC_TEST Next Generation Sequencing (NGS)
- DIAGNOSTIC_TEST Long Range NGS HLA typing
Study Locations (16)
California
- City of Hope - Duarte
- University of California San Diego - La Jolla
- Stanford University - Palo Alto
- UCLA Medical Center - Santa Monica
Arizona
- Banner Health - Gilbert
- Mayo Clinic Hospital - Phoenix
Florida
- Mayo Clinic Jacksonville - Jacksonville
- Moffitt Cancer Center - Tampa
Massachusetts
- Massachusetts General Hospital/Dana Farber Cancer Institute - Boston
Minnesota
- Mayo Clinic Rochester - Rochester
Missouri
- Washington University - St Louis
New York
- NYU Langone Medical Center - New York
Ohio
- The Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-10-29 |
| Est. Completion | 2029-04 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04981119
The ClinicalTrials.gov registry entry for NCT04981119 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (70% lower). The listed sponsor is A2 Biotherapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Apheresis is the first listed.
NCT04981119 reports 16 study locations spanning 11 distinct geographic areas - top geographies include California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT04981119 about?
NCT04981119 is a clinical study titled "Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing". Objective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Des...
What is the current status of trial NCT04981119?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2021-10-29. Estimated completion is 2029-04.
What conditions does trial NCT04981119 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Ovarian Cancer, Pancreatic Cancer, Solid Tumor, Adult.
What interventions are being tested in trial NCT04981119?
The interventions under investigation include: Apheresis (OTHER), Next Generation Sequencing (NGS) (DIAGNOSTIC_TEST), Long Range NGS HLA typing (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04981119?
This trial is sponsored by A2 Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04981119 being conducted?
This trial has 16 study locations across Arizona, California, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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