Actively Recruiting
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
Led by A2 Biotherapeutics Inc. · Updated on 2025-09-09
240
Participants Needed
10
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrollment in the BASECAMP-1 study with tissue showing loss of HLA-A*02 by next generation sequencing
- Histologically confirmed recurrent unresectable, locally advanced, or metastatic colorectal, non-small cell lung, head and neck squamous cell, triple-negative breast, renal cell carcinoma, or other solid tumors with EGFR expression
- Measurable disease with lesions 1.0 cm or larger by CT scan
- Received prior required therapy for the solid tumor as described in the protocol
- Adequate organ function per protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of 3 months or more
- Willingness to comply with study assessments and long-term safety follow-up
You will not qualify if you...
- Disease suitable for local therapy or receiving standard care therapy that is not palliative
- Prior allogeneic stem cell transplant
- Prior solid organ transplant
- Cancer therapy within 3 weeks or 3 half-lives before A2B395 infusion
- Radiotherapy within 28 days before A2B395 infusion
- Significant cardiac disease such as unstable angina, arrhythmia, or myocardial infarction within the last 6 months
- New symptomatic pulmonary embolism or deep vein thrombosis within 3 months of enrollment; therapeutic anticoagulation allowed if more than 3 months ago and adequately treated
- History of interstitial lung disease requiring prolonged steroids or immunosuppressants within 1 year
- Requirement for supplemental home oxygen
- Pregnant or breastfeeding females of childbearing potential
- Male and female subjects of childbearing potential unwilling to use birth control from consent through 6 months post-infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
UCLA Medical Center
Los Angeles, California, United States, 90404
Actively Recruiting
4
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Moffitt Cancer Center
Tampa, Florida, United States, 33606
Actively Recruiting
6
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
8
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
9
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
10
Fred Hutch Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
C
Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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