Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Clinical Study of CD19/CD20 tanCAR T Cells in Relapsed and/or Chemotherapy Refractory B-cell Leukemias and Lymphomas
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory
into patient autologous or donor-derived T cells may make the body build immune response to
kill cancer cells.
PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in
treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell
transplantation or intensive chemotherapy) or refractory to chemotherapy.
PRIMARY OBJECTIVES:
To assess the efficacy of TanCAR19/20 T cells in relapsed or refractory NHL, defined as
overall response rate (ORR).
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of TanCAR19/20 T cells. II. To evaluate time to
response (TTR), duration of overall response (DOR), progression free survival (PFS) and
overall survival (OS).
III. To determine in vivo expansion and persistence of TanCAR19/20 T cells.
OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive
anti-CD19/20-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced
autologous T cells on day1 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3
months for 2 years, and annually thereafter for 3 years.
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