NCT02259556

CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).

Detailed description

When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days. Extra blood will be drawn to measure the persistence of CART30 in vivo.

Conditions

• Hodgkin's Lymphoma
• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CART30	Cells will be infused 1 day after the completion of conditioning regimen.

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-10-01
• Completion: 2029-10-01
• First posted: 2014-10-08
• Last updated: 2016-01-28

Locations

1 site across 1 country: China