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
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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
Sponsor: A2 Biotherapeutics Inc.
You may qualify if…
- ✓ Key Inclusion Criteria:
- ✓ 1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\*02 by NGS (whenever possible from the primary site).
- ✓ 2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Measurable disease is required with lesions of ≥1.0 cm by CT.
- ✓ 3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol
- ✓ 4. Has adequate organ function as described in the protocol
- ✓ 5. ECOG performance status of 0 to 1
- ✓ 6. Life expectancy of ≥3 months
- ✓ 7. Willing to comply with study schedule of assessments including long-term safety follow-up
Where it's recruiting
Gilbert
La Jolla · Los Angeles
Jacksonville · Tampa
Rochester
St Louis
New York
Columbus
Seattle
Source: ClinicalTrials.gov · NCT06682793 · last updated 2025-09-09