This is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory B cell malignancy by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with refractory acute lymphoblastic leukemia and Lymphomas.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
1 - 2×10\^6 Anti-CD19 CAR-T cells/kg body weigh
The First Affiliated Hospital of Nangchang University
Nanchang, Jiangxi, China
RECRUITINGOverall responce rate(ORR)
Assessment of ORR (ORR = CR+PR ) at 2 months of treatment
Time frame: 2 years
Overall survival (OS)
Assessment of OS(Overall survival) at 6 months of treatment
Time frame: 2 years
Progression-free survival (PFS)
Assessment of PFS(Progression-free survival ) at 6 months of treatment
Time frame: 2 years
minimal residual disease(MRD)
Assessment of MRD negative overall response rate at 3 months of treatment
Time frame: 2 years
Safety (incidence of adverse events defined as dose-limited toxicity)
Occurrence of study related adverse events defined as NCI CTCAE 4.0 \> grade 3 possibly, probably, or definitely related to study treatment.
Time frame: Study treatment until Week 24
Expression of CD19 CART cells
Expression of CD19 CART cells detected by flow cytometry in blood and bone marrow.
Time frame: 2 years
Detection of CD19 CART cells
Detection of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).
Time frame: 2 years
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