Study on the Safety and Effectiveness of A2B530 CAR T-Cell Therapy for Solid Tumors with CEA Expression and HLA-A*02 Loss

Sponsor: A2 Biotherapeutics Inc.

Sponsor score: 0

ClinicalTrials ID:NCT05736731

Provider View

This clinical trial is testing a new CAR T-cell therapy called A2B530 in adults with certain solid tumors, like colorectal and pancreatic cancer, that express CEA and have lost HLA-A*02. The study aims to find the safest dose and see if the treatment can effectively target cancer cells while sparing healthy cells.

Patient Parameters

Program Overview

The purpose of this study is to evaluate a new CAR T-cell therapy, A2B530, in adults with solid tumors such as colorectal, pancreatic, and non-small cell lung cancer. These tumors must express a protein called CEA and have lost a specific genetic marker, HLA-A*02. The study is divided into two phases: Phase 1 will determine the safest dose of A2B530, and Phase 2 will assess if this dose can effectively kill cancer cells while protecting healthy cells. Participants will undergo various procedures, including T-cell collection and preconditioning treatment, before receiving the A2B530 therapy.

Description

This study involves testing a new treatment called A2B530 CAR T-cell therapy in adults with certain types of solid tumors that are difficult to treat with standard methods. These tumors must express a protein called CEA and have lost a genetic marker known as HLA-A*02. The study is conducted in two phases: Phase 1 focuses on finding the safest dose of A2B530, while Phase 2 evaluates how well this dose works in treating the cancer.

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 can join this study (EVEREST-1) to receive the A2B530 therapy. The treatment involves a preconditioning regimen to prepare the body, followed by the infusion of the modified T cells.

The study aims to provide a safer and more effective treatment option by targeting cancer cells while sparing healthy cells. This is achieved through a special safety mechanism in the A2B530 cells that prevents them from attacking normal tissues. Participants will be closely monitored for safety and effectiveness throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Must have participated in the BASECAMP-1 study and have stored T cells available for therapy.
  • Have a confirmed diagnosis of recurrent, advanced, or metastatic solid tumors like colorectal, lung, or pancreatic cancer that express CEA.
  • Have measurable disease with tumors larger than 1 cm on a CT scan.
  • Have received previous standard treatments for their cancer.
  • 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 long-term follow-up requirements.

Exclusion Criteria

  • Have cancer that can be treated with local or standard therapies that are not just for symptom relief.
  • Have had a previous stem cell or organ transplant.
  • Have received cancer therapy or radiation recently before the A2B530 infusion.
  • Have significant heart disease or recent heart issues.
  • Have had a recent blood clot in the lungs or deep veins unless treated and stable.
  • Require home oxygen.
  • Be pregnant or breastfeeding, or not willing to use birth control during and after the study.

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