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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
A2 Biotherapeutics Inc.
Study ID
NCT06682793
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • A2B395 — BIOLOGICAL
    Allogeneic logic-gated Tmod CAR T cells
  • xT CDx with HLA-LOH assay — DIAGNOSTIC_TEST
    An investigational next generation sequencing (NGS) in vitro diagnostic (IVD) medical device

Study Details

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 Dates

Start date
May 22, 2025
Status verified
Sep 2025
Primary completion
Mar 31, 2029
Completion
Mar 31, 2030

Study Design

Enrollment
240 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: A2B395
    Participants receive preconditioning lymphodepletion (PCLD) regimen followed by a single dose of A2B395 intravenously on day 0

Primary Outcome Measure

Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose level [ Time Frame: From the time of Informed consent until 24 months (2 years) post A2B395 infusion ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234
Kylie Ketchum
[email protected]
Matthew Ulrickson, MD (PRINCIPAL_INVESTIGATOR)
UCSD Moores Cancer CenterLa JollaCalifornia92093
Rebecca Shatsky
[email protected]
Rebecca Shatsky, MD (PRINCIPAL_INVESTIGATOR)
UCLA Medical CenterLos AngelesCalifornia90404
Lisa Del Rio
[email protected]
Deborah Wong, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicJacksonvilleFlorida32224
Clinical Trials Referral Office
855-776-0015
Yanyan Lou, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33606
Gillian Zankel
[email protected]
Kedar Kirtane, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Clinical Trials Referral Office
855-776-0015
Harry E. Fuentes Bayne, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63110
Amberly Scott
[email protected]
Patrick Grierson, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
# Phase1Screening
#[email protected]
Salman Punekar, MD
[email protected]
Salman Punekar, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Cindi Jenkins
[email protected]
Kai He, MD, PhD (PRINCIPAL_INVESTIGATOR)
Fred Hutch Cancer CenterSeattleWashington98109
Shelby Colden
[email protected]
Jennifer Specht, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gilbert, AZ

By condition
Colorectal cancerHead and neck cancerKidney cancerLung cancerBreast cancer
By specialty
OncologyGI oncologyENTUrologyLung oncologyLung diseaseBreast oncologyWomen's health
By research site
Banner MD Anderson Cancer Center· Gilbert, AZUCSD Moores Cancer Center· La Jolla, CAUCLA Medical Center· Los Angeles, CAMayo Clinic· Jacksonville, FLMoffitt Cancer Center· Tampa, FLMayo Clinic· Rochester, MN

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