A Study of Metabolically Armed BCMA CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Plasma Cell Neoplasms.
Age 19 to 75 years old, male or female. The subject or his/her guardian voluntarily signed the informed consent;
Subjects with relapsed or refractory Plasma Cell Neoplasms（including Multiple Myeloma, Plasma Cell Leukemia, AL Amyloidosis）according to IMWG criteria and have had at least 3 prior lines of therapy (including chemotherapy based on proteasome inhibitors and immunomodulatory agents). Disease progression must be documented during or within 12 months following the most recent anti-myeloma treatment (for subject whose last-line treatment was CAR-T, disease progression was not limited to occurring within 12 months after treatment).
Evidence of cell membrane BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue.
The subjects were unable to receive autologous hematopoietic stem cell transplantation treatment, or relapsed after autologous hematopoietic stem cell transplantation, and the researchers determined that treatment was needed.
Any hematopoietic stem cell transplant(HSCT) within 2 months prior to the start of infusion of Meta10-BCMA, or any immunosuppressive therapy due to graft-versus-host disease after HSCT within the screening period;
Any major surgery within 4 weeks prior to screening;
Any radiotherapy 2 weeks prior to screening;
Any intrathecal treatment within 1 week prior to the start of infusion of Meta10-BCMA;
Sequential
Metabolically Armed BCMA CAR-T cells.
DrugEach subject receive metabolically armed BCMA CAR- T cells by intravenous infusion.
MTD
Determine the Maximal Tolerable Dose(MTD)
Adverse events (AEs)
Adverse events will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Cmax
The maximum concentration (Cmax) of CAR-T cell expansion in peripheral blood
Pharmacodynamics
Concentration levels of CAR-T related serum cytokines such as CRP, IL-6, INF-γ at each time point.
Objective response rate (ORR)
According to the IMWG 2016 version, evaluate the overall tumor response rate (including sCR, CR, VGPR, PR) and the number of subjects in each dose group and all subjects at 1 month, 3 months, 6 months, 9 months and 12 months after CAR-T treatment.
Overall survival (OS)
OS is measured from the date of the infusion of Meta10-BCMA to the date of the subjects' death.
Click on the lead sponsor to view all of their trials.
Anhui Provincial Hospital
Lead sponsor
Leman Biotech Co., Ltd.
Collaborator
