The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.
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
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
30mg/m2/d
300mg/m2/d
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGSafety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
Time frame: 6 months
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Time frame: 8 weeks
Duration of CAR-positive T cells in circulation
Duration of CAR-positive T cells in circulation
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Immune inhibitors