A2 Biotherapeutics Inc. is recruiting patients for an observational prescreening study (BASECAMP-1) that collects tumor tissue and apheresis samples to support potential future CAR-T cell therapy for people with solid tumors.

The trial, designated NCT04981119, aims to enroll up to 200 participants at sites across the United States. This study does not administer CAR-T therapy. Cells collected here may be used to manufacture CAR-T products for follow-on interventional studies such as EVEREST-2 (NCT06051695).

About the Study

Objective:

To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant’s own T cells for future use to make CAR T-Cell therapy for their disease treatment.

Design:

This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant’s tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant’s cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.

Treatment Approach

BASECAMP-1 is a prescreening registry, not a treatment study. No CAR-T therapy is administered here. Eligible participants undergo biopsy analysis (HLA loss-of-heterozygosity testing by next-generation sequencing) and leukapheresis so cells can be stored for potential future CAR-T manufacturing if disease recurs. People who qualify may later enroll in A2 Biotherapeutics’ interventional CAR-T trials, including EVEREST-2 for mesothelin-expressing solid tumors.

Key trial details:

Phase: Observational (not applicable)
Sponsor: A2 Biotherapeutics Inc.
Enrollment target: 200
Status: Recruiting

Why This Trial Matters

CAR-T cell therapy has revolutionized treatment for blood cancers, and researchers are working to adapt this approach for solid tumors like mesothelioma.

Study Locations

The trial is recruiting at:

Banner Health, Arizona
Mayo Clinic Hospital, Arizona
City of Hope, California
University of California San Diego, California
Stanford University, California

How to Enroll

Patients interested in this trial should:

Discuss eligibility with their oncologist
Review the full eligibility criteria on ClinicalTrials.gov
Contact the study coordinator for screening