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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: Recruiting study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by A2 Biotherapeutics.
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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (69% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants will be followed for their status of enrollment on an A2 Biotherapeutics, Inc. interventional study
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 |
What NCT04981119 shows while recruiting
NCT04981119 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (69% lower).
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 lists 16 locations in 11 states (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.
Learn More About Clinical Trials
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Where NCT04981119's enrollment target sits among peer trials
200 164th of 454 higher than 288 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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