This pilot study examines the safety and efficacy of anti-CD19 CAR T cells manufactured on-site in children and young adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.
Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 CAR T cell infusion. The lymphodepleting chemotherapy is administered over four days IV to prepare the body for the CAR T cells. The anti-CD19 CAR-T cells are infused between 2-14 days after the last dose of chemotherapy. This study is designed for participants to begin lymphodepleting chemotherapy during the CAR T cell manufacture and receive a fresh cell infusion on the day that manufacturing is complete. Some patients may need more time in between the cell collection and the CAR T cell infusion, therefore, the cells may be manufactured and frozen prior to administration. Patients will be followed for a year after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.
Second or greater relapse OR
Any relapse after allogeneic SCT OR
Not achieving a CR after 2 cycles of standard chemotherapy regimen (including persistent MRD positive disease) OR
Not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia (including persistent MRD positive disease) OR
Acute/ongoing neurologic toxicity > Grade 1 with the exception of a history of controlled seizures or fixed neurologic deficits that have been stable/improving over the past 1 months.
Active untreated infection. Viremia by PCR analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic.
Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
Presence of Grade 2 to 4 acute or extensive chronic graft versus-host disease (GVHD) at the time of enrollment
Single group
CD19 specific Chimeric Antigen Receptor T Cell
Biological/VaccineInfusion of CD19 CAR-T Cells manufactured on-site using the CliniMACS Prodigy
Proportion of products successfully manufactured and infused with a goal of 0.3-1 x 10^6 per kilogram for patients <50 kg and a flat dose of 0.3-1 x 10^8 for patients ≥50 kg
Reported as the proportion of products successfully manufactured and infused
Incidence and severity of adverse events
Summarized with descriptive statistics
Overall response rate
Proportion of patients achieving a response at 1 month post infusion
Complete response rate for B cell Acute Lymphoblastic Leukemia
Complete response rate at 1 month post infusion
Best overall response for B cell Non-Hodgkin's Lymphoma
Best overall response (complete response, partial response, stable disease, progressive disease)
MRD negative response rates for Acute Lymphoblastic Leukemia
MRD status at 30 days post infusion will be presented with descriptive statistics. MRD will be performed utilizing both flow cytometry and NGS.
CD19 CAR T cell persistence
Measured by flow cytometry or PCR
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