๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-09-03

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 (NCT06682793)

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmodโ„ข 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

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: A2 Biotherapeutics Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The goal of this study is to test A2B395, an allogeneic logic-gated Tmodโ„ข 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

Who can join: Review the eligibility criteria below.

Location: Banner MD Anderson Cancer Center โ€” Gilbert, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (10 Sites)

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

๐Ÿ“ž Contact the Study Coordinator

Phone: (310) 431-9180

Email: ClinicalTrials@a2bio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—