This is an open, single-arm, prospective,clinical study to evaluate efficacy and safety of Auto CAR-T cell injection in the treatment of recurrent or refractory Hematopoietic and Lymphoid Tissue Tumors in Children
A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Biological: Auto CAR-T
Drug: Cyclophosphamide,Fludarabine
Leukapheresis
Pediatric hematology, Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 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 month post CAR-T cells infusion
Efficacy: Remission Rate
Remission Rate including complete remission(CR)、partial response(PR)、No remission(NR)、progressive disease(PD)
Time frame: 3 months post CAR-T cells infusion
Efficacy:duration of response (DOR)
duration of response (DOR)
Time frame: 24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)
progression-free survival (PFS) time
Time frame: 24 months post CAR-T cells infusion
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