Recruiting
Phase 1
Phase 2

A2B694

Sponsor:

A2 Biotherapeutics Inc.

Code:

NCT06051695

Conditions

Solid Tumor, Adult

Colorectal Cancer

NSCLC

Non Small Cell Lung Cancer

NSCLC, Recurrent

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

A2B694

A2B543

xT CDx with HLA-LOH Assay

Study Details

Brief summary:

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

Conditions

Solid Tumor, Adult

Colorectal Cancer

NSCLC

Non Small Cell Lung Cancer

NSCLC, Recurrent

Study ID

NCT06051695

Start date

Apr 3, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy
2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN 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. MESO with pleural involvement extending into the peritoneum
5. Cancer therapy within 3 weeks or 3 half lives of infusion
6. Radiotherapy within 28 days of infusion
7. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months
8. 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
9. 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
10. Requires supplemental home oxygen
11. Females of childbearing potential who are pregnant or breastfeeding
12. 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

Study Design

Enrollment

474 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

A2B694

Autologous logic-gated Tmod CAR T cells

A2B543

Autologous logic-gated Tmod CAR T cells

xT CDx with HLA-LOH Assay

An investigational next generation sequencing (NGS) in vitro diagnostic (IVD) medical device

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 ]
  • Phase 1: Recommended Phase 2 Dose (RP2D) [ Time Frame: 21 days post infusion ]
  • Phase 2: The Overall Response Rate (ORR) for patients [ Time Frame: 24 months post infusion ]

Central Contacts and Locations

Central contacts

Locations

Banner Health

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Principal Investigator:

Matthew Ulrickson, MD

UCSD Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

Sandip Patel, MD

UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90404

Contacts

Principal Investigator:

J. Randolph Hecht, MD

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Kayla McDaniel

mcda59@stanford.edu

Principal Investigator:

Oliver Dorigo, MD

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Principal Investigator:

Yanyan Lou, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33606

Contacts

Principal Investigator:

Monica Avila, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Teri Heddlesten Rediske

HeddlestenRediske.Teri@mayo.edu

Principal Investigator:

Julian Molina, MD, PhD

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Jeffery Ward, MD

NYU Langone Medical Center

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Salman Punekar, MD

The Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Jinesh Gheeya, MD, PhD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)

1-800-811-8480CTIP@VUMC.ORG

Principal Investigator:

Cathy Eng, M.D., FACP, FASCO

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Principal Investigator:

David Zhen, MD

More Information

Sponsor

A2 Biotherapeutics Inc.

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • CAR T Cell
  • Solid Tumors
  • Autologous
  • T Cell
  • Mesothelin
  • MSLN
  • HLA-A2
  • Solid Tumors expressing MSLN
  • Pancreatic
  • Cell Therapy
  • Gene Therapy
  • blocker
  • Cancer
  • PANC
  • CRC
  • Colorectal Cancer
  • Lung Cancer
  • NSCLC
  • OVCA
  • MESOM
  • Ovarian Cancer
  • Mesothelioma
  • Logic-gate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by A2 Biotherapeutics Inc. on 2026-06-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.