Eque-cel for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
brief summary
This study is a single-armed, open-label, multicenter Phase 1/2 study to evaluate the efficacy and safety of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) in subjects with relapsed and refractory Multiple Myeloma.
detailed description
This study is divided into two stages: Part 1 and Part 2. Part 1: For exploratory research purposes, no more than 3 subjects will be enrolled at an exploratory dose.
Part 2: The purpose of this phase is to explore the efficacy of Equecabtagene Autoleucel (Eque-cel) as a last-line treatment for RRMM and further confirm its safety.
In this Study，Leukapheresis procedure will be performed to manufacture Eque-cel modified T cells. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide is performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of Eque-cel at 1.0 x 10\^6 CAR+ T cells/Kg or 0.5 x 10\^6 CAR+ T cells/Kg（if all three subjects in Part 1 experience the Toxicity Requiring Dose Reduction）. Subjects will be followed in the study for a minimum of 2 years after Eque-cel infusion.
official title
A Phase I/II Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma