Health Trials

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

ConditionsSolid Tumor, AdultColorectal CancerNSCLCNon Small Cell Lung CancerNSCLC, RecurrentNon-Small Cell Squamous Lung CancerPancreas CancerPancreatic NeoplasmColorectal AdenocarcinomaCRCColon CancerRectal CancerCancerOvarian CancerOvarian NeoplasmsMesotheliomaMesothelioma, MalignantOvary CancerLung CancerMESOM
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorA2 Biotherapeutics Inc.

About this trial

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

Eligibility criteria

Qualifiers

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

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.

Received previous required therapy for the appropriate solid tumor disease as described in the protocol

Has adequate organ function as described in the protocol

Disqualifiers

Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative

Prior allogeneic stem cell transplant

Prior solid organ transplant

MESO with pleural involvement extending into the peritoneum

Trial design

Treatments tested in this trial

  • A2B694
  • A2B543
  • xT CDx with HLA-LOH Assay

Treatment groups

474 Participants
are divided into 2 treatment groups

Locations

12
Arizona
Banner Health85234, Gilbert United States
California
UCSD Moores Cancer Center92093, La Jolla United States
UCLA Medical Center90404, Los Angeles United States
Stanford University94305, Stanford United States

Sponsors and collaborators

A2 Biotherapeutics Inc.

Lead sponsor

Tempus AI

Collaborator

Source ClinicalTrials.gov