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 Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: 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 Key Exclusion Criteria: 1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative 2. Prior allogeneic stem cell transplant 3. Prior solid organ transplant 4. Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion 5. Radiotherapy within 28 days of A2B395 infusion 6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months 7. 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 8. 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 9. Requires supplemental home oxygen 10. Females of childbearing potential who are pregnant or breastfeeding 11. 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
Study sites (10)
AZ
- Banner MD Anderson Cancer Center · Gilbert, AZ 85234Kylie Ketchum · Study contact · kylie.ketchum@bannerhealth.comMatthew Ulrickson, MD · Principal investigatorMore trials in Gilbert
CA
- UCSD Moores Cancer Center · La Jolla, CA 92093Jona Plevin · Study contact · jplevin@health.ucsd.eduRebecca Shatsky · Study contact · rshatshy@health.ucsd.eduRebecca Shatsky, MD · Principal investigatorMore trials in La Jolla
- UCLA Medical Center · Los Angeles, CA 90404Lisa Del Rio · Study contact · ldelrio@mednet.ucla.eduDeborah Wong, MD · Principal investigatorMore trials in Los Angeles
FL
- Mayo Clinic · Jacksonville, FL 32224Clinical Trials Referral Office · Study contact · 855-776-0015Yanyan Lou, MD · Principal investigatorMore trials in Jacksonville
- Moffitt Cancer Center · Tampa, FL 33606Gillian Zankel · Study contact · Gillian.Zankel@moffitt.orgKedar Kirtane, MD · Principal investigatorMore trials in Tampa
MN
- Mayo Clinic · Rochester, MN 55905Clinical Trials Referral Office · Study contact · 855-776-0015Harry E. Fuentes Bayne, MD · Principal investigatorMore trials in Rochester
MO
- Washington University · St Louis, MO 63110Amberly Scott · Study contact · amberly@wustl.eduPatrick Grierson, M.D., Ph.D. · Principal investigatorMore trials in St Louis
NY
- NYU Langone Health · New York, NY 10016# Phase1Screening · Study contact · #phase1screening@nyulangone.orgSalman Punekar, MD · Study contact · Salman.punekar@nyulangone.orgSalman Punekar, MD · Principal investigatorMore trials in New York
OH
- The Ohio State University · Columbus, OH 43210Cindi Jenkins · Study contact · Cynthia.Jenkins@osumc.eduKai He, MD, PhD · Principal investigatorMore trials in Columbus
WA
- Fred Hutch Cancer Center · Seattle, WA 98109Shelby Colden · Study contact · scolden2@fredhutch.orgJennifer Specht, MD · Principal investigatorMore trials in Seattle