A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis
POEMS syndrome, amyloidosis, autoimmune hemolytic anemia, vasculitis and other diseases may only show local pathological damage or systemic lesions. If they are not diagnosed and treated in time or poorly controlled, they will progress as the course of the disease progresses. Risk of disability or even death.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Each subject receive CD19/BCMA CAR T-cells by intravenous infusion
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGDose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Baseline up to 28 days after CD19/BCMA targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame: Up to 2 years after CD19/BCMA targeted CAR T-cells infusion
Titer of auto-antibody Titer of auto-antibody titer of auto-antibody
In peripheral blood and bone marrow
Time frame: Up to 2 years after CD19/BCMA targeted CAR T-cells infusion
Overall response rate (ORR)
Proportion of subjects with complete or partial remission
Time frame: Up to 2 years after CD19/BCMA targeted CAR T-cells infusion
Best overall response, BOR
Assessment of ORR at ≤3 month
Time frame: At ≤3 month
Overall survival (OS)
The time from the cell reinfusion to death due to any cause
Time frame: From CD19/BCMA CAR-T infusion to death,up to 2 years
Duration of remission, DOR
The time from the first assessment of remission or partial remission of the disease to the first assessment of disease progression or death from any cause
Time frame: 2 years post CD19/BCMA CAR-T cells infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.