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NCT06682793 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression
A Phase 1 study of Cancer and Lung Cancer, sponsored by A2 Biotherapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 240
- Enrollment target
- 10
- Study locations
NCT06682793 is a Phase 1 study of Cancer and Lung Cancer that is actively recruiting participants, run by A2 Biotherapeutics. The registered enrollment target is 240 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (93% lower). The trial reports 10 study locations across 8 states.
The verdict
NCT06682793, a Phase 1 study of Cancer and Lung Cancer, is actively recruiting participants, sponsored by A2 Biotherapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 240 participants
- Enrollment target
- 10
- Study locations
Study Summary
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the recommended dose of A2B395 that is safe for patients * Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: * Enrollment in BASECAMP-1 (NCT04981119) * Preconditioning lymphodepletion (PCLD) regimen * A2B395 Tmod CAR T cells at the assigned dose
Conditions Studied
Interventions
- BIOLOGICAL A2B395
- DIAGNOSTIC_TEST xT CDx with HLA-LOH assay
Study Locations (10)
California
- UCSD Moores Cancer Center - La Jolla
- UCLA Medical Center - Los Angeles
Florida
- Mayo Clinic - Jacksonville
- Moffitt Cancer Center - Tampa
Arizona
- Banner MD Anderson Cancer Center - Gilbert
Minnesota
- Mayo Clinic - Rochester
Missouri
- Washington University - St Louis
New York
- NYU Langone Health - New York
Ohio
- The Ohio State University - Columbus
Washington
- Fred Hutch Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2025-05-22 |
| Est. Completion | 2030-03-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06682793
The ClinicalTrials.gov registry entry for NCT06682793 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (93% lower). The listed sponsor is A2 Biotherapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which A2B395 is the first listed.
NCT06682793 reports 10 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06682793 about?
NCT06682793 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression". The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma ...
What is the current status of trial NCT06682793?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 240 participants. The study started on 2025-05-22. Estimated completion is 2030-03-31.
What conditions does trial NCT06682793 study?
This clinical trial studies the following conditions: Cancer, Lung Cancer, Colorectal Cancer, Colon Cancer, Solid Tumor, Adult.
What interventions are being tested in trial NCT06682793?
The interventions under investigation include: A2B395 (BIOLOGICAL), xT CDx with HLA-LOH assay (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06682793?
This trial is sponsored by A2 Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06682793 being conducted?
This trial has 10 study locations across Arizona, California, Florida, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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