Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies
The CAR-T cell injection uses immune cells from healthy donors, and is the final product obtained after CAR genetic modification, cell expansion, culture, screening, preparation, sub-packaging, and release inspection. CD38 is highly expressed in myeloid leukemia, and it has been confirmed that the treatment of targeting CD38 has great potential in the treatment of CD38-positive hematological malignancies. The center intends to apply for a clinical trial of CD38 CAR-T cells to treat CD38-positive hematological malignancies on the basis of preliminary research.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Drug: CD38 CAR T-cells Each subject receive CD38 CAR T-cells by intravenous infusion Other Name: CD38 CAR T-cells injection
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 CD38 CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame: Up to 90 days after CD38 CAR T-cells infusion
Concentration of CAR-T cells
In peripheral blood and bone marrow
Time frame: From admission to the end of the follow-up, up to 2 years
Disease control rate, DCR
The percentage of patients with remission and stable disease after treatment in the total evaluable cases.
Time frame: From Day 28 CD38 CAR-T infusion 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: 24 months post CD38 CAR-T cells infusion
Progression-free survival, PFS
The time from cell reinfusion to the first assessment of disease progression or death from any cause
Time frame: 24 months post CD38 CAR-Tcells infusion
Overall survival, OS
The time from the cell reinfusion to death due to any cause
Time frame: From CD38 CAR-T infusion to death,up to 2 years
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