This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Primary objective: To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia. Secondary objective: To Assess the patient's quality of life after receiving the treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
T cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, China
RECRUITINGObjective Response Rate, ORR
The percentage of participants who achieved complete remission (CR) over all participants (CRR). The percentage of participants who achieved partial remission (PR) over all participants (PRR).
Time frame: Up to Day90 after the CD19-CAR-T cell infusion
The amount of CAR-T cells remaining in vivo
Measure and analyze monthly
Time frame: 2 years after cell infusion.
The lifetime of CAR-T cells remaining in vivo
Measure and analyze monthly
Time frame: 2 years after cell infusion.
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