To evaluate the safety and efficacy of Human BCMA Targeted T Cells Injection for the treatment of BCMA-positive relapsed/refractory multiple myeloma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.
Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/PET, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Autologous genetically modified anti-BCMA CAR transduced T cells
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China
RECRUITINGShanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGNumber of participants with treatment-related adverse events as assessed by NCI-CTCAE 5.0
Time frame: 28 days post infusion
Concentration of Anti-BCMA CAR T Cells in blood
Time frame: 2 years post infusion
Concentration of Anti-BCMA CAR T Cells in bone marrow
Time frame: 2 years post infusion
Pharmacodynamics (Levels of Cytokines in Serum)
Time frame: 2 years post infusion
Pharmacodynamics (Content of clonal plasma cells in bone marrow)
Time frame: 2 years post infusion
Overall response rate (ORR) after administration
Time frame: 3 months post infusion
Negative proportion of minimal residual disease (MRD)
Time frame: 28 days post infusion
Duration of remission (DOR) after administration
Time frame: 2 years post infusion
Progress Free Survival (PFS) after administration
Time frame: 2 years post infusion
Overall Survival (OS)after administration
Time frame: 2 years post infusion
Positive incidence of anti-drug antibody
Time frame: 2 years post infusion
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