Open-Label, Multicenter, Single Ascending Dose Study to Assess the Safety of P-BCMA-101 in Subjects with Relapsed / Refractory Multiple Myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety (PRIME)
Syed abbas Ali
Johns Hopkins Kimmel Cancer Center in Baltimore
The primary purpose of this study is to establish the safety and highest tolerated dose level of P-BCMA-101. These will be determined based on toxicities acquired from each dose level. This is a phase 1 study for adults who have relapsed and/or refractory Multiple Myeloma.
Age 18+. Must have confirmed, measurable diagnosis of active relapsed and/or refractory MM. Must have been out of autologous stem cell transplant for at least 90 days, and be in good physical condition with good organ function. Patients must not be pregnant, and must be willing to practice birth control.
After screening, patients must undergo leukapheresis, white blood cell extraction, to make the P-BCMA-101. Patients will return five days before P-BCMA-101 infusion for conditioning chemotherapy. After three days of chemotherapy and two rest days, patients are infused with P-BCMA-101. All patients are admitted to the hospital the night before administration and up to 10 days after. Patients return for regular follow up to monitor safety, tolerability, and anti-myeloma response of P-BCMA-101.
08/08/2020 05:02 AM