Mantle Cell Lymphoma Clinical Trial
Official title:
Anti-CD19 Chimeric Antigen Receptor Modified T Cells Infusion in Mantle Cell Lymphoma
Patients receive anti-CD19-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells over a period of 4 or 5 consecutive days in an escalating dose. After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 10 years.
PRIMARY OBJECTIVES:
I. Determine the safety and efficacy of the chimeric antigen receptor T cells transduced
with the anti-CD19 (cluster of differentiation antigen 19 ) vector (referred to as CART-19
cells) in elderly patients with MCL.
II. Determine duration of in vivo survival of CART-19 cells. RT-PCR (reverse transcription
polymerase chain reaction) analysis of whole blood will be used to detect and quantify
survival of CART-19 TCR (T-cell receptor) zeta:CD137 and TCR zeta cells over time.
SECONDARY OBJECTIVES:
For patients with detectable disease, measure anti-tumor response due to CART-19 cell
infusions.
Estimate relative trafficking of CART-19 cells to tumor in bone marrow and lymph nodes.
Determine if cellular or humoral host immunity develops against the murine anti-CD19, and
assess correlation with loss of detectable CART-19 (loss of engraftment).
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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