To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.
Main research purposes: To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies. Secondary research purposes: Objective Evaluation of Cytodynamic Characteristics of CAR-T in Different Types of Hematological Malignancies
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Biological: CAR-T; Drug: Cyclophosphamide,Fludarabine;Procedure: Leukapheresis
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
RECRUITINGSafety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Time frame: First 1 month post CAR-T cells infusion
Efficacy: Remission Rate
Complete remission (CR) Complete remission with incomplete recovery of blood cells (CRI), positive minimal residual tumor (MRD+) or negative tumor (MRD -) CR/CRI, disease recurrence or progression (PD) were evaluated, and the overall remission rate was ORR=CR+CRI; For drenching Complete remission (CR), partial remission (PR), disease stability (SD) Disease recurrence or progression (PD) was evaluated, and the overall remission rate was ORR=CR+PR; For multiple myeloma Complete remission (CR), partial remission (VGPR, PR), disease stability (SD), disease recurrence or progression (PD) were adopted, Overall remission rate ORR=CR+VGPR+PR;
Time frame: 3 months post CAR-T cells infusion
progression-free survival (PFS)
progression-free survival (PFS) time
Time frame: 24 months post CAR-T cells infusion
CAR-T proliferation
the copy number of Senl CAR- T cells in the genomes of PBMC by qPCR method
Time frame: 3 months post CAR-T cells infusion
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
Time frame: 1 month post CAR-T cells infusion
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