Study on the Safety and Effectiveness of A2B694 CAR T-Cell Therapy for Solid Tumors with MSLN Expression and HLA-A*02 Loss

Sponsor: A2 Biotherapeutics Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06051695

Provider View

This clinical trial is testing a new CAR T-cell therapy called A2B694 to see if it is safe and effective in treating solid tumors like colorectal, pancreatic, lung, ovarian cancers, and others that have specific characteristics. The study aims to find the best dose and determine if the treatment can target cancer cells while protecting healthy cells.

Patient Parameters

Program Overview

The study is investigating a new treatment called A2B694, a type of CAR T-cell therapy, for patients with certain solid tumors, including colorectal, pancreatic, lung, ovarian cancers, and others. These tumors must express a protein called MSLN and have lost a specific genetic marker, HLA-A*02. The study has two phases: Phase 1 will determine the safest dose of A2B694, and Phase 2 will evaluate if this dose effectively kills cancer cells while sparing healthy cells. Participants will undergo various procedures, including a pre-screening study to collect and store their T cells, which will later be modified and infused back into their bodies as part of the treatment.

Description

This study is designed to test a new CAR T-cell therapy, A2B694, in adults with certain types of solid tumors that are difficult to treat with standard therapies. The study is open to patients with cancers like colorectal, pancreatic, lung, ovarian, and mesothelioma, among others, that have specific characteristics. The treatment involves collecting a patient's T cells, modifying them in the lab to target cancer cells, and then infusing them back into the patient. The study aims to find the safest and most effective dose of A2B694.

Participants must first enroll in a pre-screening study called BASECAMP-1, where their T cells are collected and stored. If their cancer progresses, they may join this study, EVEREST-2, where their stored T cells are modified and infused back into them after a preconditioning treatment. The study will explore whether A2B694 can effectively target and kill cancer cells while protecting healthy cells, offering a potential new treatment option for patients with these challenging cancers.

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in the BASECAMP-1 study and have T cells collected and stored.
  • Have a confirmed diagnosis of certain solid tumors like colorectal, lung, pancreatic, ovarian cancers, or mesothelioma, with specific characteristics.
  • Have received previous treatments for their cancer as required by the study.
  • Have good organ function and a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a life expectancy of at least 3 months.
  • Be willing to follow the study schedule and attend follow-up appointments.

Exclusion Criteria

  • Have cancer that can be treated with local therapy or standard treatments that are not just for symptom relief.
  • Have had a previous stem cell or organ transplant.
  • Have mesothelioma with specific spread to the abdomen.
  • Have received cancer therapy or radiation recently before the study treatment.
  • Have significant heart disease or recent heart problems.
  • Have had a recent blood clot in the lungs or deep veins.
  • Have a history of lung disease requiring long-term treatment.
  • Require home oxygen.
  • Be pregnant or breastfeeding, or not willing to use birth control during and after the study.

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