Stopped: Terminated due to slow enrollment and end of funding
This phase I trial studies the side effects of huJCAR014 in treating patients with relapsed or refractory B-cell non-Hodgkin lymphoma or acute lymphoblastic leukemia. huJCAR014 CAR-T cells are made in the laboratory by genetically modifying a patient's T cells and may specifically kill cancer cells that have a molecule CD19 on their surfaces. In Stage 1, dose-finding studies will be conducted in 3 cohorts: 1. Aggressive B cell NHL 2. Low burden ALL 3. High burden ALL In Stage 2, studies may be conducted in one or more cohorts to collect further safety, PK, and efficacy information at the huJCAR014 dose level(s) selected in Stage 1 for the applicable cohort(s). There are two separate cohorts for stage 2: 1. Cohort 2A, CAR-naĂŻve (n=10): patients who have never received CD19 CAR-T cell therapy. 2. Cohort 2B, CAR-exposed (n=27): patients who have previously failed CD19 CAR-T cell therapy.
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Incidence of toxicity
Timeframe: Up to 30 days after the final dose of study therapy
Dose-limiting toxicity (DLT) rates
Timeframe: Up to 28 days
Maximum concentration (Cmax) of autologous human anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing CD4+/CD8+ T-lymphocytes (huJCAR014) cells in blood
Timeframe: Up to 28 days
Time to maximum concentration (Tmax), of huJCAR014 cells in blood
Timeframe: Up to 28 days
Area under the curve of huJCAR014 cells in blood
Timeframe: Up to 28 days
Presence of huJCAR014 cells in bone marrow
Timeframe: Up to 28 days