The FDA has cleared an investigational treatment for multiple myeloma to be used in a clinical trial.
A release from the manufacturer said the FDA cleared the Investigational New Drug application for P-BCMA-ALL01, a fully allogeneic CAR-T treatment to be evaluated for relapsed/refractory multiple myeloma. The company is planning a phase 1 open-label dose-escalation trial to start later this year. The release noted that after a patient enrolls in the trial, they will be given a single dose of allogeneic CAR-T cells followed by a standard chemotherapy-based conditioning regimen. Patients enrolled will be evaluated for safety, tolerability, and response.
“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,” said Eric Ostertag, MD, PhD, Chief Executive Officer of Poseida Therapeutics, in the release. “P-BCMA-ALL01 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.”
Ostertag added in the release that the company believes more Tscm and an improved binder give the treatment the potential to be even more effective than other drugs currently being used.
The release noted that the study protocol allows researchers to explore more dosing regimens, including using new doses after the drug’s safety is established.
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