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Clinical trialNCT06682793RecruitingPhase 1/PHASE2Interventional

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

SponsorA2 Biotherapeutics Inc.Enrollment240CRCCancerColon CancerColorectal AdenocarcinomaColorectal CancerHNSCC+11 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Banner Md Anderson Cancer Center

    Gilbert, Arizona, United States

    Matthew Ulrickson, MD
    Recruiting
  • Ucsd Moores Cancer Center

    La Jolla, California, United States

    Rebecca Shatsky, MD
    Recruiting
  • Ucla Medical Center

    Los Angeles, California, United States

    Deborah Wong, MD
    Recruiting
  • Mayo Clinic

    Jacksonville, Florida, United States

    Yanyan Lou, MD
    Recruiting
  • Moffitt Cancer Center

    Tampa, Florida, United States

    Kedar Kirtane, MD
    Recruiting
  • Mayo Clinic

    Rochester, Minnesota, United States

    Harry E. Fuentes Bayne, MD
    Recruiting
  • Washington University

    St Louis, Missouri, United States

    Patrick Grierson, M.D., Ph.D.
    Recruiting
  • Nyu Langone Health

    New York, New York, United States

    Salman Punekar, MD
    Recruiting
  • the Ohio State University

    Columbus, Ohio, United States

    Kai He, MD, PhD
    Recruiting
  • Fred Hutch Cancer Center

    Seattle, Washington, United States

    Jennifer Specht, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

A2B395
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
22 May 2025
Primary completion
31 Mar 2029
Completion
31 Mar 2030
Last update posted
9 Sept 2025
Registered enrollment
240
Registry id
NCT06682793

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.