A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
A2 Biotherapeutics Inc.
Study ID
NCT06051695
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • A2B694 — BIOLOGICAL
    Autologous logic-gated Tmod CAR T cells
  • A2B543 — BIOLOGICAL
    Autologous 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 autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression. The main questions this study aims to answer are: Phase 1: What is the recommended dose that is safe for patients Phase 2: Does the recommended dose kill 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 and Apheresis in BASECAMP-1 (NCT04981119) Preconditioning Lymphodepletion (PCLD) Regimen Tmod CAR T cells at the assigned dose

Key Dates

Start date
Apr 3, 2024
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
474 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: A2B694
    Patients receive preconditioning lymphodepletion (PCLD) regimen followed by a single dose of A2B694 intravenously on day 0
  • Experimental: Arm 2: A2B543
    Patients receive preconditioning lymphodepletion (PCLD) regimen followed by a single dose of A2B543 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 infusion ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Banner HealthGilbertArizona85234
Matthew Ulrickson, MD (PRINCIPAL_INVESTIGATOR)
UCSD Moores Cancer CenterLa JollaCalifornia92093
Sandip Patel, MD (PRINCIPAL_INVESTIGATOR)
UCLA Medical CenterLos AngelesCalifornia90404
Nicole Williams
[email protected]
J. Randolph Hecht, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityStanfordCalifornia94305
Kayla McDaniel
[email protected]
Oliver Dorigo, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicJacksonvilleFlorida32224
Rhoda Romain
[email protected]
Yanyan Lou, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33606
Nathana Zelleke
[email protected]
Monica Avila, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905
Teri Heddlesten Rediske
[email protected]
Julian Molina, MD, PhD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63110
Amberly Scott
[email protected]
Jeffery Ward, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone Medical CenterNew YorkNew York10016
Peter Warren
[email protected]
Salman Punekar, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Dudbeth Brown
[email protected]
614-685-7034
Jinesh Gheeya, MD, PhD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)
[email protected]
1-800-811-8480
Cathy Eng, M.D., FACP, FASCO (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109
Shelby Colden
[email protected]
David Zhen, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Banner Health· Gilbert, AZUCSD Moores Cancer Center· La Jolla, CAUCLA Medical Center· Los Angeles, CAStanford University· Stanford, CAMayo Clinic· Jacksonville, FLMoffitt Cancer Center· Tampa, FL

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