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

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
• Non-Small Cell Squamous Lung Cancer
• Pancreas Cancer
• Pancreatic Neoplasm
• Colorectal Adenocarcinoma
• CRC
• Colon Cancer
• Rectal Cancer
• Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Mesothelioma
• Mesothelioma, Malignant
• Ovary Cancer
• Lung Cancer
• MESOM

Interventions

BIOLOGICAL

A2B694

Autologous logic-gated Tmod CAR T cells

BIOLOGICAL

A2B543

Autologous logic-gated Tmod CAR T cells

DIAGNOSTIC_TEST

xT CDx with HLA-LOH Assay

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

Sponsors & Collaborators

• Tempus AI

  collaborator INDUSTRY

• A2 Biotherapeutics Inc.

  lead INDUSTRY

Principal Investigators

• John Welch, MD, PhD · A2 Biotherapeutics

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-03

Primary Completion

2028-06-30

Completion

2029-06-30

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations