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.
Primary Objectives 1. To determine the feasibility ad safety of BCMA CAR-T cells in treating patients with multiple myeloma. 2. To determine in vivo dynamics and persistency of BCMA CAR-T cells. 3. To access the efficacy of BCMA CAR-T cells in patients with multiple myeloma. Secondary Objectives 1. To assess the bone marrow and tumor migration of BCMA CAR-T cells. 2. To investigate the tumor killing capability of BCMA CAR-T cells in vitro 3. To investigate the possibility of host immune response to the mouse derived BCMA scFv, and evaluate its correlation to CAR-T persistence. 4. To correlate the subsets and differentiation of BCMA CAR-T cells to observed anti-tumor efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
dose: 25mg/m2/d
Dose: 40mg/kg
Henan Province of TCM
Zhengzhou, Henan, China
RECRUITINGSafety 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 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
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Time frame: 6 months
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