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J. Randolph (Randy) Hecht, MD, discusses the observational BASECAMP-1 study and the investigation of HLA-A*02 as a target for the novel CAR T-cell therapy A2B530 in the phase 1/2 EVEREST-1 study, which will investigate A2B530 in patients with solid tumors.
J. Randolph (Randy) Hecht, MD, professor, clinical medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), director, UCLA Gastrointestinal Oncology Program, discusses the observational BASECAMP-1 study (NCT04981119) and the investigation of HLA-A*02 as a target for the novel CAR T-cell therapy A2B530 in the phase 1/2 EVEREST-1 study (NCT05736731), which will investigate A2B530 in patients with solid tumors.
The objective of the observational study is to proactively pinpoint patients at high risk of disease relapse who are eligible for CAR T-cell therapy and collect their blood cells for the potential future manufacture of CAR T-cell therapy upon disease relapse, Hecht begins. BASECAMP-1 isn't designed as a treatment-oriented trial, but rather, functions primarily as a screening and leukapheresis study, once patients have been identified, Hecht explains. In many clinical trial designs, patients enter and are assigned to a treatment arm based on tumor or patient characteristics, he notes. However, the BASECAMP-1 approach differs slightly, as patients are identified early in the process, with treatment occurring at a later stage, Hecht emphasizes.
BASECAMP-1 is adaptable, allowing for adjustments as needed, he expands. Its current configuration is tailored to patients with significant malignancies such as non–small cell lung cancer, colorectal cancer, and pancreatic cancer, Hecht explains. The term "good shape" assumes significance in identifying patients whose normal tissue carries the HLA-A*02 allele, which their tumors lack, he adds. Subsequently, leukapheresis is performed on their cells to collect and store them before extensive chemotherapy is administered, Hecht explains. Upon identification, patients can seamlessly proceed to receive CAR T-cell therapy while their cells remain in optimal condition, Hecht emphasizes.
In recent years, there has been a streamline of trials like BASECAMP-1, he continues. Previously, early trial participants were required to have exhausted all approved or guideline-recommended treatment options, Hecht notes. This often meant subjecting patients to minimally effective therapies that had accumulated over the years, Hecht explains. However, these regulations have evolved, making it more convenient for patients to participate in trials such as BASECAMP-1, he concludes.