An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
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
Trial Status: active
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
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
Additional locations may be listed on ClinicalTrials.gov for NCT06682793.
