NCT03473496

CAR-T Cells Therapy in Relapsed/Refractory Multiple Myeloma

The Prospective, Multi-center And Single-arm Clinical Study of Chimeric Antigen Receptor T(CAR-T) Cells Therapy in Relapsed/Refractory Multiple Myeloma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy.The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized, and several clinical trials have been reported in the treatment of multiple myeloma with CAR-T cells.

Detailed description

Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways. In recent years, the understanding of pathogenic molecular mechanism in MM , many new types of drugs can be used in the treatment of this disease, one of the most widely used is proteasome inhibitors and immune regulator.Hematopoietic stem cell transplantation has also been shown to improve complete remission rates and prolong patient survival.Combined with the advantages of multiple therapies, chimeric antigen receptor T cells (CAR-T) have gradually become one of the strongest and most powerful weapons against multiple myeloma. CAR - T cells was taken in the form of genetic modification, and specific identified target antigen monoclonal antibody of single variable region (scFv) expression in T cell surface, and coupled with the activation of intracellular proliferation signal domain. When scFv recognizes antigens expressed in malignant cells, it stimulates the activation signal of downstream T cells and produces specific killing effects. CAR-T therapy is one of revolutionary targeted immunotherapy.The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized, and several clinical trials have been reported in the treatment of multiple myeloma with CAR-T cells.Throughout registration of clinical trials and published research results, B-cell maturation antigen (BCMA) as one of targets , its effect is more significant than other molecules.As with BCMA antigens, cluster of differentiation 138(CD138), cluster of differentiation 56 (CD56) or cluster of differentiation 38(CD38) antigens are also highly expressed in multiple myeloma cells.With CD138 as the target for the treatment of CAR-T cells, several clinical studies have been registered, and the results show that some of them are effective. In order to lay a foundation for the application of relapsed/refractory multiple myeloma patients with CAR-T therapy，objects are refractory/ relapsed patients with multiple myeloma,and plans to into the group of the number of cases in 50 cases.The main content is safety, efficacy and feasibility analysis of the CAR-T cells （single CAR-T or double CAR-T cells with BCMA、CD138、CD56 or CD38 ) in the treatment of refractory/relapsed multiple myeloma.

Conditions

• Relapsed/Refractory Multiple Myeloma(MM)

Interventions

Type	Name	Description
BIOLOGICAL	CART therapy in Relapsed/Refractory multiple myeloma	one kind of BCMA/CD138/CD38/CD56-CART therapy in Relapsed/Refractory multiple myeloma

Timeline

• Start date: 2018-03-01
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2018-03-22
• Last updated: 2024-03-15

Locations

1 site across 1 country: China