Infusion of Allogeneic, 3rd Party CD19-specific T Cells
Blood And Marrow Transplantation, Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Blood And Marrow Transplantation focused on measuring Blood And Marrow Transplantation, Leukemia, Lymphoma, CD19-specific T cells, Acute lymphoblastic leukemia, ALL, Biphenotypic leukemia, Non-Hodgkin's Lymphoma, NHL, Diffuse large B-cell lymphoma, Small lymphocytic lymphoma, Follicular lymphoma, Mantle cell lymphoma, Chronic lymphocytic leukemia, CLL
Eligibility Criteria
Inclusion Criteria:
- Patients with a history of refractory B-cell lymphoid malignancies: 1) acute lymphoblastic leukemia (ALL), CD19+, 2) biphenotypic leukemia CD19+, 3) non-Hodgkin's Lymphoma (NHL), which includes diffuse large B-cell lymphoma, small lymphocytic lymphoma, follicular lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia (CLL).
- Age 18 to 70 years.
- Zubrod performance 0-2 or Karnofsky greater than or equal to 60%.
- Patient or patient's legal representative able to provide written informed consent.
- Patient or patient's legal representative able to provide written informed consent for the long-term follow-up gene therapy study.
- Patients must be a minimum of 3 months from last hematopoietic stem cell transplant (HSCT) and 3 weeks from last systemic chemotherapy.
Exclusion Criteria:
- Patients with known allergy to bovine or murine products.
- Clinically significant acute or chronic GVHD requiring systemic immunosuppression, including methylprednisolone >/= 1 mg/kg/day.
- Systemic corticosteroid use within 72 hours of treatment initiation.
- Antibody to HLA expressed on 3rd party T cells.
- Experiencing any new Grade >2 (CTC version 4) adverse neurologic, pulmonary, cardiac, gastrointestinal, renal or hepatic (excluding albumin) event within 24 hours prior to treatment initiation.
- Active infection defined as positive culture, if available, for bacteria, fungus, or virus within a 3-day period prior to treatment initiation and/or fever greater than 38ยฐC within 24 hours prior to treatment initiation.
- Positive beta HCG by qualitative pregnancy test in female of child-bearing potential defined as not post menopausal for 12 months or absence of previous surgical sterilization.
Sites / Locations
Arms of the Study
Arm 1
Experimental
T-Cell Administration
Cyclophosphamide 60 mg/kg by vein for 2 consecutive days, followed by Fludarabine at 25 mg/m2/day by vein for 5 consecutive days. Fludarabine dose calculated per adjusted ideal body weight. T-cell product divided into 2 portions. Up to 25% of the genetically modified cells given on first day, with plan to infuse up to 75% of the remaining T-cell dose no sooner than 24 hours after completion of first portion. Second portion should not be given later than 72 hours after first portion. First group of 3 participants receive lowest dose of T-cells. Each new group receive a higher dose of T-cells than the group before it, if no intolerable side effects were seen. Up to 6 dose levels of T-cells will be tested.