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

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor, Adult, Colorectal Cancer, Non-Small Cell Lung, NSCLC (Non-small Cell Lung Cancer), Cancer, Colon Cancer, Rectal Cancer, Lung Cancer, CRC, Head and Neck Squamous Cell Cancer, HNSCC, Renal Cell Carcinoma, RCC, Kidney Cancer, Triple Negative Breast Cancer, TNBC, Colorectal Adenocarcinoma

In brief

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

Key facts

Study ID

NCT06682793

Run by

A2 Biotherapeutics Inc.

People needed

240

Starts

2025-05-22

Expected to finish

2030-03-31

Last updated by the study team

2025-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Key Inclusion Criteria:
• 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).
• 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.
• Received previous required therapy for the appropriate solid tumor disease as described in the protocol
• Has adequate organ function as described in the protocol
• ECOG performance status of 0 to 1
• Life expectancy of ≥3 months
• Willing to comply with study schedule of assessments including long-term safety follow-up
• Key Exclusion Criteria:
• Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative
• Prior allogeneic stem cell transplant
• Prior solid organ transplant
• Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion
• Radiotherapy within 28 days of A2B395 infusion
• Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months
• Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated
• History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year
• Requires supplemental home oxygen
• Females of childbearing potential who are pregnant or breastfeeding
• Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B395

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
• UCSD Moores Cancer Center — La Jolla, California, United States (enrolling)
• UCLA Medical Center — Los Angeles, California, United States (enrolling)
• Mayo Clinic — Jacksonville, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• Fred Hutch Cancer Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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