This is a single-center, single-arm, open-label, exploratory study to determine the safety, tolerability, feasibility, and preliminary anti-tumor activity of anti-CD19-CAR-T cells in subjects with relapsed/refractory (r/r) B-cell malignancies.
This study plans to enroll patients with relapsed/refractory CD19-positive B-cell malignancies, who will receive a single infusion of anti-CD19-CAR-T cells after screening, PBMC collection, and lymphodepleting chemotherapy.
Patient able to provide written informed consent; parent or guardian of minor patient able to provide written informed consent; ability and willingness to adhere to the study visit schedule and all protocol requirements.
14 - 70 years old.
Relapsed/refractory disease after standard treatment (including allogeneic/autologous hematopoietic stem cell transplantation) and not eligible for other treatment options such as a second hematopoietic stem cell transplant.
Primary refractory disease.
CNS-3, defined as detectable tumor cells in cerebrospinal fluid (CSF) with ≥ 5 white blood cells (WBCs) /mm3.
CNS-2, defined as detectable tumor cells in CSF with <5 WBCs /mm3. Note: Subjects with CNS-1 (no detectable tumor cells in CSF) or CNS-2 without evidence of clinically significant neurological changes are eligible for this study.
CNS lymphoma confirmed by MRI; active CNS DLBL unless CNS involvement has been effectively treated (i.e., asymptomatic) and a local treatment interval of > 4 weeks prior to enrollment.
Active CNS diseases such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disorders, or any autoimmune diseases involving the central nervous system.
Single group
Anti-CD19-CAR-T cells
GeneticEach subject will be infused with single dose of anti-CD19-CAR-T cells. A classic "3+3" dose escalation will be employed.
Fludarabine
DrugFludarabine will be given at a dose of 25 mg/m2/day intravenously (IV) for 3 days prior to anti-CD19-CAR-T cells infusion.
Cyclophosphamide
DrugCyclophosphamide will be given at a dose of 250 mg/m2/day intravenously (IV) for 3 days prior to anti-CD19-CAR-T cells infusion.
Safety and tolerance
Incidence of dose-limiting toxicity (DLT)
Manufacturing feasibility
Percentage of subjects for whom the required dose of anti-CD19-CAR-T cells can be successfully manufactured.
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Shanghai First Song Biotechnology Co., LTD
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborator
