The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.
Primary Objectives 1\. To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with BCMA-positive multiple myeloma. Secondary Objectives 1. To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma. 2. To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs
30mg/m2/d
300mg/m2/d
Department of Hematology ,Fudan University Zhongshan Hospital
Shanghai, China
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time frame: 6 months
Overall remission rate defined by the standard response criteria for myeloma for each arm
Overall remission rate defined by the standard response criteria for myeloma 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.