Mantle Cell Lymphoma Clinical Trial
Official title:
Immunotherapy With Ex Vivo-Expanded Cord Blood-Derived CAR-NK Cells Combined With High-Dose Chemotherapy and Autologous Stem Cell Transplantation for B-Cell Lymphoma
This phase I/II trial studies the side effects and best dose of chimeric antigen receptor (CAR).CD19-CD28-zeta-2A-iCasp9-IL15-transduced cord blood NK cells when given together with high-dose chemotherapy and stem cell transplant and to see how well they work in treating participants with B-cell lymphoma. Cord blood-derived CAR-NK cells may react against the B-cell lymphoma cells in the body, which may help to control the disease. Giving chemotherapy before a stem cell transplant may help kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PRIMARY OBJECTIVES:
I. To establish the safety and relative efficacy of
CAR.CD19-CD28-zeta-2A-iCasp9-IL15-transduced cord blood natural killer (CB-NK) cells in
patients with B cell non-Hodgkin lymphoma (NHL) undergoing high dose chemotherapy and
autologous stem cell transplantation.
SECONDARY OBJECTIVES:
I. To estimate the relapse-free survival (RFS). II. To estimate the overall survival (OS).
III. To quantify the persistence of infused CAR.CD19-CD28-zeta-2A-iCasp9-IL15-transduced
CB-NK cells in the recipient.
OUTLINE: This is a phase I, dose-escalation study of
CAR.CD19-CD28-zeta-2A-iCasp9-IL15-transduced CB-NK cells followed by a phase II study.
Participants receive rituximab intravenously (IV) over 3 hours on days -14 and -8, carmustine
IV over 2 hours on day -13, etoposide IV over 3 hours twice daily (BID) on days -12 to -9,
cytarabine IV over 1 hour BID on days -12 to -9, melphalan IV over 30 minutes on day -8,
CAR.CD19-CD28-zeta-2A-iCasp9-IL15-transduced CB-NK cells IV over 1 hour on day -5.
Participants undergo autologous stem cell transplantation (ASCT) on day 0. Beginning day 0,
participants receive filgrastim subcutaneously (SC) once daily (QD) until evidence of an
absolute neutrophil count (ANC) of 0.5 x 10^9/L per 3 consecutive days.
After completion of study treatment, participants are followed for up to 15 years.
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