Diane Simeone, MD, on Screening Patients for CAR-T Eligibility Before Solid Tumor Relapse

“I think we clinicians that take care of patients with solid tumors have been sitting on the sideline and seeing pretty significant efficacy of CAR-T-based therapies in hematologic malignancies. I think that in the next 5 to 10 years that there will be significant advances in the application of CAR-T-based therapies and other cell therapies for solid tumors.”

Patients with metastatic solid tumors often undergo surgical resection of their tumors. However, in many cases, the surgery is not curative, and the patient’s cancer eventually relapses.

A2 Biotherapeutics’ observational BASECAMP-1 clinical trial (NCT04981119) is evaluating patients who have been treated for solid tumors and are at a high risk of relapse. The study seeks to identify patients with somatic human leukocyte antigen loss of heterozygosity (HLA LOH), specifically those with LOH for HLA-A*02, who could potentially be treated with A2 Biotherapeutics’ investigational logic-gated Tmod chimeric antigen receptor T-cell (CAR-T) therapy if their cancer relapses. The Tmod CAR-T will be evaluated in the EVEREST clinical trial, which is expected to begin in the first half of 2023.

Diane Simeone, MD, Laura and Isaac Perlmutter professor of surgery, Department of Surgery, NYU Grossman School of Medicine, presented a poster on the design and rationale for BASECAMP-1 at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting, held November 8-12, 2022, in Boston, Massachusetts.

In an interview with CGTLive, Simeone discussed the progress that has occurred in the BASECAMP-01 and EVEREST studies so far, noting that BASECAMP-1 has activated several sites and begun screening and testing patients, with several patients having been identified as potential candidates for EVEREST. These patients are undergoing leukapheresis to store their cells for CAR-T manufacturing in the event of a relapse. Simeone mentioned that the study will eventually expand from its initial 3 indications of colorectal cancer, non-small cell lung cancer, and pancreatic cancer, to also include patients with gynecologic cancers, head and neck cancers, and potentially other cancer types. She also discussed some of the challenges encountered so far, specifically pointing out the difficulties in obtaining good biopsies for pancreatic tumors.

REFERENCE

Simeone DM, Morelli MP, Hecht JR, et al. BASECAMP-1: Leveraging HLA loss of heterozygosity in solid tumors by NGS to identify patients with relapsed solid tumors for future CEA and MSLN logic-gated Tmod CAR T-cell therapy. Presented at: SITC 37th Annual Meeting, November 8012, 2022, in Boston, Massachusetts. Poster #639