* Brief Summary: Cluster of differentiation 19 (CD19) is expressed on B cells. CD19+ tumor cells in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia can be targeted using T cells expressing CD19-specific chimeric antigen receptor (CAR). * Objective: This study aims to evaluate the safety and efficacy of single-dose anti-CD19 CAR T-cell therapy in the treatment of relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia. * Eligibility: People aged 1 to 60 years with relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia. * Design: Phase 1 clinical trial, uncontrolled, single dose of CD19 CAR T-cells.
Objectives: * Evaluate the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy. * Evaluate the response rate after CD19 CAR T-cell infusion according to the following criteria: * Proportion of patients with complete response and partial response after CD19 CAR T-cell infusion * Progression-free survival (PFS) after infusion of CD19 CAR T-cells * Event-free survival (EFS) after infusion of CD19 CAR T-cells * Overall survival (OS) after infusion of CD19 CAR T-cells
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
For Biological: CD19 CAR T-cells * Dose: 1-2.10e6 cells/kg of weight * Route: intravenous infusion For Chemotherapy Drug: * Fludarabine (30 mg/m2/day) given intravenously (IV) on day -5 to -3. * Cyclophosphamide 500 mg/m2/day for NHL and 250 mg/m2/day for ALL given IV from day -5 to -3. * Mesna 500 mg/m2/day for NHL and 250 mg/m2/day for ALL, divided in three infusions: one day before the cyclophosphamide infusion, and 4 and 8 hours after.
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Hanoi, Vietnam
Assessment of the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy
The incidence of adverse events (AEs) and serious adverse events (SAEs) will be recorded and classified according to CTCAE v5 (grade 1-5). CRS and ICANs will be classified using the ASTCT criteria (grade 1-5). These parameters will be used to assess the safety of the therapy.
Time frame: 6 months
Proportion of patients with complete response and partial response after CD19 CAR T-cell infusion (%)
Patients with B-ALL will receive bone marrow biopsy assessed on day 30 and day 90 to check blast frequency and MRD. The response will be classified according to NCCN guidelines. Patients with NHL will be examined PET-CT or CT on day 90. The response will be classified according to Cheson guidelines.
Time frame: Day 30 and day 90 after CAR-T infusion for B-ALL; day 90 after CAR-T infusion for NHL
Progression-free survival (PFS) (months)
PFS is defined as the time from CAR T-cell infusion, until disease progression or death from any cause. Progression is defined as an increase of tumor load, the development of new lesions.
Time frame: 6 months
Event-free survival (EFS) (months)
EFS is defined as time to treatment failure (including complete remission with incomplete hematologic or platelet recovery), relapse from complete remission, or death from any cause.
Time frame: 6 months
Overall survival (OS) (months)
EFS is defined as time to death
Time frame: 6 months
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