Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Clinical Study of CD19/CD22 Tan CAR 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:
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced
with the anti-CD19/CD22 vector (referred to as tanCART-19/22 cells).
II. Determine duration of in vivo survival of tanCART-19/22 cells. RT-PCR (reverse
transcription polymerase chain reaction) analysis of whole blood will be used to detect and
quantify survival of tanCART-19/22TCR (T-cell receptor) zeta:CD137 and TCR zeta cells over
time.
SECONDARY OBJECTIVES:
I. For patients with detectable disease, measure anti-tumor response due to tanCART-19/22
cell infusions.
II. CD137 transgene is measured by the relative engraftment levels of tanCART-19/22 CD137 and
TCR zeta cells over time.
III. Estimate relative trafficking of tanCART-19/22 cells to tumor in bone marrow and lymph
nodes.
IV. For patients with stored or accessible tumor cells (such as patients with active chronic
lymphocytic leukemia(CLL), acute lymphocytic leukemia (ALL), etc) determine tumor cell
killing by tanCART-19/22 cells in vitro.
V. Determine if cellular or humoral host immunity develops against the murine anti-CD19/22,
and assess correlation with loss of detectable tanCART-19/20 (loss of engraftment).
VI. Determine the relative subsets of tanCART-19/22 T cells (Tcm, Tem, and Treg).
OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive
anti-CD19/22-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced
autologous T cells on days 0,1, and 2 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 13 years.
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