A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia

You may be eligible if

• Patients must be ≥12 months of age and \<27 years of age at the time of study enrollment.
• Must be ≥10kg
• Confirmed CD19+ leukemia recurrence defined as ≥0.01% disease in the marrow or isolated extramedullary disease following allogeneic HCT. \[N.B. Study closed to enrollment of leukemia subjects\]
• OR
• No prior history of allogeneic HCT (one of the following)
• 2nd or greater relapse, with or without extramedullary disease (isolated extramedullary disease is eligible)
• 1st marrow relapse at end of 1st month of re-induction with marrow having ≥0.01% blast disease, with or without extramedullary disease
• Primary Refractory as defined as having M2 or M3 marrow after induction
• Subject has indication for HCT but has been deemed ineligible
• OR
• CD19+ Non-Hodgkin Lymphoma (NHL) refractory or relapsed with no known curative therapies available \[N.B. Study remains open to enrollment of lymphoma subjects\]
• Patients with CNS involvement are eligible provided that they are asymptomatic and in the opinion of the study PI have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T cell infusion. Patients that have a significant neurologic deterioration will be not be eligible for T cell infusion until alternate therapies result in neurological stabilization.
• Patients must have a Lansky performance status score of ≥50 or a Karnofsky score of ≥ 50 for patients ≥16 years of age.
• Life Expectancy of \>8 weeks
• Patients must be free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment.
• Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
• It must be at least 7 days since last chemotherapy was administered (this does not include intrathecal chemotherapy or maintenance chemotherapy)
• No systemic corticosteroids (unless physiologic replacement dosing) within 7 days of enrollment.
• No prior genetically modified cell therapy that is still detectable or virotherapy allowed.
• Normal serum creatinine based on age/gender
• Total bilirubin \</3x ULN OR conjugated bilirubin \</2mg/dl
• ALT \</5X ULN
• SF of \>28% by ECHO or EF \>50% by MUGA
• ALC of \>/= 100 cells/ul
• Pulse ox \>/= 90% on room air
• Patient must have documented negative HIV antigen and antibody, Hepatitis B surface antigen, and Hepatitis C antibody within 3 months prior to enrollment. For patient with positive Hepatitis C Ab, negative PCR testing must be documented in order to be eligible.
• Patients must NOT have active clinically significant CNS dysfunction (including but not limited to such as uncontrolled seizure disorder, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
• Must agree to highly effective contraception during and for 12 months after T cell infusion.
• Patients must be able to tolerate apheresis procedure, including placement of temporary apheresis line if required.
• Patients must NOT have an active malignancy other than CD19+ leukemia.
• Patients must NOT have an active severe infection defined as:
• A positive blood culture within 48 hours of study enrollment
• A fever above 38.2 C AND clinical signs of infection within 48 hours of study enrollment
• Patients must NOT have any concurrent medical condition that, in the opinion of the PI or designee, would prevent the patient from undergoing protocol-based therapy. Patients with a primary immunodeficiency/ bone marrow failure syndrome are excluded from this trial.
• Research participant or parent/legal guardian must agree to participate in long-term follow-up for up to 15 years, if they are enrolled in the study and receive T-cell infusion.