Clinical Study on the Safety and Effectiveness of CLL1 CAR-T Cells in the Treatment of CLL1-positive Hematological Malignancies
Human C-type lectin-like molecule 1 (CLL1) is a type II transmembrane glycoprotein ,CLL1 expression is restricted to bone marrow cells and most AML blasts. In addition, CLL1 is expressed in leukemia stem cells (LSC) but not in hematopoietic stem cells (HSC), may provide a potential therapeutic target for the treatment of AML.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. The center intends to apply for a clinical trial of CLL1 CAR-T cells to treat CLL1-positive hematological malignancies on the basis of preliminary research.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Drug: CLL1 CAR T-cells Each subject receive CLL1 CAR T-cells by intravenous infusion Other Name: CLL1 CAR T-cells injection
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGThe First Hospital of Zhejiang Medical Colleage 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 CLL1 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 CLL1 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 CLL1 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 CLL1 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 CLL1 CAR-Tcells infusion
Overall survival, OS
The time from the cell reinfusion to death due to any cause
Time frame: From CLL1 CAR-T infusion to death,up to 2 years
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