NCT04186052

Clinical Trial of BCMA CAR T Cell Infusion in Patients With BCMA-positive r/r Multiple Myeloma

Clinical Study Protocol for Targeting BCMA Autochimeric Antigen Receptor T Cell Infusion One-arm, Single-center, Open-label Clinical Trial of BCMA Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With BCMA-positive Relapsed/Refractory Multiple Myeloma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Multiple myeloma is a kind of hematological malignancy caused by the proliferation of malignant clonal plasma cells. In recent years, the emergence of new therapeutic drugs such as bortezomib and lenalidomide has significantly improved the therapeutic effect of mm. However, due to the presence of myeloma stem cells, most patients will inevitably relapse and die. With the development of biomedicine and immunology, immunotherapy with chimeric antigen receptor modified T cells has attracted great attention for its amazing efficacy. CAR-T cells carry receptors that can specifically recognize myeloma associated antigens, and their killing effect is not limited by MHC molecules. B-cell mature antigen is only expressed on the surface of B cells in germinal center, malignant and normal plasma cells, not on other normal human tissues and CD34 + hematopoietic stem cells. It is a relatively specific high expression on the surface of myeloma cells, which is an ideal target for MM immunotherapy. The aim of this study was to investigate the efficacy and safety of BCMA targeted T cell infusion in the treatment of BCMA positive multiple myeloma.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	BCMA-CART cells	Target BCMA chimeric antigen receptor T cell infusion

Timeline

• Start date: 2019-03-08
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2019-12-04
• Last updated: 2019-12-04

Locations

1 site across 1 country: China