NCT01886976

Treatment of Chemotherapy Refractory Multiple Myeloma by CART-138

Clinical Study of Chimeric CD(Cluster of Differentiation)138 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Multiple Myelomas

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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 to study genetically engineered lymphocyte therapy in treating patients with CD138 positive multiple myeloma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.

Detailed description

PRIMARY OBJECTIVES: I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD138 vector (referred to as CART-138 cells). II. Determine duration of in vivo survival of CART-138 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood and bone marrow will be used to detect and quantify survival of CART-138 TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over time. SECONDARY OBJECTIVES: I. For patients with detectable disease, measure anti-myeloma response due to CART-138 cell infusions. II. To determine if the CD137 transgene is superior to the TCR zeta only transgene as measured by the relative engraftment levels of CART-138 TCR zeta:CD137 and TCR zeta cells over time. III. Estimate relative trafficking of CART-138 cells in bone marrow. IV. For patients with stored or accessible myeloma cells, determine myeloma cell killing by CART-138 cells in vitro. V. Determine if cellular or humoral host immunity develops against the murine anti-CD138, and assess correlation with loss of detectable CART-138 (loss of engraftment). VI. Determine the relative subsets of CART-138 T cells (Tcm, Tem, and Treg). OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive anti-CD138-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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	CART-138 cells

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-06-26
• Last updated: 2016-01-28

Locations

1 site across 1 country: China