This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.
Primary objectives 1. To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives 2. To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Ex vivo-expanded autologous T cells modified to express CD19 CAR
Patients were given cyclophosphamide 500mg/m2/day on day -4 and fludarabine at 25 mg/m2/day on day -4, day -3, and day -2.
Patients were given cyclophosphamide 500mg/m2/day on day -4.
The First Affilicated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGSafety - incidence of adverse events defined as dose-limited toxicity
incidence of adverse events defined as dose-limited toxicity
Time frame: 180 days
Overall complete remission rate
Overall complete remission rate
Time frame: 1 year
Duration of remission
Duration of remission
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.