Mayo Clinic
This phase I trial studies the effects of CD-19 directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with B cell malignancies that have come back (recurrent) or have not responded to treatment (refractory). CD-19 CAR-T cells use some of a patient's own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. Some T cells are removed from the blood, and then laboratory, researchers will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat cancer. The new modified T cells are called the IC19/1563 treatment. IC19/1563 may help treat patients with relapsed/refractory B cell malignancies.
PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose of in-house, point of care manufactured autologous anti-CD19 CAR-expressing T-lymphocytes IC19/1563 (IC19/1563) in patient with relapsed/refractory B cell malignancies. SECONDARY OBJECTIVES: I. Assess the feasibility of in-house, point of care manufactured IC19/1563 cells. II. Evaluate safety, including all grades of neurotoxicity (ICANS) and cytokine release syndrome as determined by the American Society for Transplantation and Cellular Therapy (ASTCT) criteria, by monitoring adverse events, laboratory abnormalities, vital sign…
Inclusion Criteria: * Age \>= 18 years * Relapsed or refractory CD19+ B cell malignancies of the one of the following histopathology: * Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease defined as: * Two or more prior lines of therapy, at least one anthracycline containing regimen, unless intolerable. Exception: Patients with Richter transformation of CLL are eligible if they had \>= one prior treatment, including prior BTK inhibition * Demonstration of progressive or stable disease by po…
Given IV
Given IV
Undergo collection of blood and tissue samples
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Undergo CT
Given IV
Given IV
Undergo MRI
Undergo CT/PET