This is an open, two arms, mask phase I clinical study to evaluate efficacy and safety of two different chimeric antigen receptor T cell immunotherapies (Senl\_1904A and Senl\_1904B) targeting cluster of differentiation antigen 19 (CD19) in the treatment of Acute lymphocytic Leukemia. A total of 20 patients are planned to be enrolled following up half a year.
The CARs consist of an anti-CD19 single-chain variable fragment(scFv) that was derived from the FMC63 mouse hybridoma, a portion of the human CD137(4-1BB) molecule, and the intracellular component of the human CD3ζ molecule. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Compared to Senl\_1904A, Senl\_1904B has a higher and more stable transfection efficiency and secretes lower levels of cytokines in functional assays, thus having the potential to significantly reduce the incidence of serious adverse events while ensuring the same complete response rate. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for one month after infusion for adverse reactions and efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Autologous CD19-targeting CAR T cells
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, China
Tumor load
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Time frame: up to one month
CAR T cell expansion
The percentage of CAR-T cells (CAR+/CD3+ T cells) in the bone marrow samples, quantified by flow cytometry.
Time frame: up to one month
CAR T cell persistence
The method to detect CAR-T cell persistence is by determining the exact copies of CAR per ug DNA in BM through quantitative polymerase chain reaction(qPCR)
Time frame: up to one month
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