FDA clears IND application for BCMA-directed allogenic CAR-T to treat multiple myeloma
The FDA cleared an investigational new drug application for P-BCMA-ALLO1, a chimeric antigen receptor T-cell therapy designed to treat adults with relapsed or refractory multiple myeloma.
P-BCMA-ALLO1 (Poseida Therapeutics) is an allogeneic, gene-edited CAR T-cell therapy that targets the B-cell maturation antigen (BCMA) on the surface of cancer cells.
The therapy comprises a high percentage of healthy donor stem cell memory T cells that are genetically edited to reduce alloreactivity and graft-versus-host disease by knocking out the T-cell receptor and major histocompatibility complex-1.
The IND clearance will allow Poseida to start enrollment for a clinical trial that will evaluate P-BCMA-ALLO1 for patients with relapsed or refractory multiple myeloma.
Study participants will undergo a chemotherapy-based precondition treatment and then receive a single dose of P-BCMA-ALLO1. Patients may receive additional doses of the CAR-T once initial safety parameters have been established, according to study protocol.
The trial will start with a 3+3 dose-escalation portion to determine the maximum tolerated dose of the cell therapy and any dose-limiting toxicities. Secondary study outcomes include treatment-related toxicity and efficacy measurements.
The phase 1 multicenter trial should begin by the end of this year, according to a company-issued press release.
This is the first allogeneic cell therapy from Poseida to advance into clinical testing.
The FDA previously granted orphan drug designation to the company’s autologous CAR-T product, P-BCMA-101, which is being evaluated as part of a phase 2 clinical trial.
“We view a fully allogeneic CAR-T product candidate comprised of a high percentage of desirable stem cell memory T cells (Tscm) as the 'holy grail' of cell therapy in oncology," Eric Ostertag, MD, PhD, CEO of Poseida Therapeutics, said in the release. "P-BCMA-ALLO1 has a very high percentage of Tscm cells with the potential to demonstrate safety in line with our prior P-BCMA-101 autologous approach, allowing for fully-outpatient dosing.”
The company’s proprietary technology allows it to produce a large number of doses during a single manufacturing run, thereby “dramatically reducing cost and further increasing accessibility for patients who desperately need better and safer cell therapies,” Ostertag said.