This is a single-arm open-label phase I/II study to determine the relative superiority of αCD19-TCRζ-CD28 and αCD19-TCRζ-CD137 CAR-T Cells in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. In this trial, all subjects will be competitively infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells in equal number to test a hypothesis that CD137-costimulation can promote the persistence and engraftment of CAR-T cells and this superiority can lead to improved progression-free survival.
Primary objectives 1\. To determine the safety and feasibility of adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives 1. To measure the efficacy of anti-tumor responses after CD19CAR T cell infusion 2. To determine if CD19CAR T cells engineered with 4-1BB signaling domain is superior to that with CD28 signaling domain for their homing and persistence after CD19CAR T cell infusion
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Ex vivo-expanded autologous T cells modified to express CD19 CAR
Henan Province of TCM
Zhengzhou, Henan, China
RECRUITINGSafety (incidence of adverse events defined as dose-limited toxicity)
Time frame: 30 days
Overall complete remission rate
Time frame: 8 weeks
Survival of CAR T cells in circulation measured by flow cytometry and PCR
Time frame: 1 year
Duration of remission
Time frame: 1 year
Overall survival
Time frame: 1 year
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