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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: Recruiting Phase 1 study of Cancer and Lung Cancer, sponsored by A2 Biotherapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Adverse events and toxicity will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (or current version). Cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and graft versus host disease (GvHD) events will be graded according to the criteria described in the current protocol.
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 |
What NCT06682793 shows while recruiting
NCT06682793 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (93% lower).
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 lists 10 locations in 8 states (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.
Learn More About Clinical Trials
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Where NCT06682793's enrollment target sits among peer trials
240 211th of 615 higher than 400 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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