NCT02081937

CART-19 Immunotherapy in Mantle Cell Lymphoma

Anti-CD19 Chimeric Antigen Receptor Modified T Cells Infusion in Mantle Cell Lymphoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Hematopoietic/Lymphoid Cancer
• Non-hodgkin Lymphoma,B Cell
• Mantle Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19-CAR vector-transduced T cells

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2014-03-07
• Last updated: 2014-03-11

Locations

1 site across 1 country: China