NCT03559764

Study of BCMA CAR-T in Multiple Myeloma

Clinical Study on the Safety and Efficacy of Anti-BCMA CAR T Cells With Relapsed and Refractory Multiple Myeloma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Allife Medical Science and Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single centre、single arm、open-label，to investigate the safety and efficacy of anti-BCMA CAR T cells in patients with Relapsed and Refractory multiple myeloma.

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.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. The study will follow a 3 + 3 design of dose-escalating cohorts. After a patient enrolls,leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce anti- BCMA CAR T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient. Treated patients will undergo serial measurements of safety, tolerability and response. 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 20 cases.

Conditions

• Relapsed and Refractory Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Anti-BCMA CAR T cells	Transparent colorless or slightly yellow liquid

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-02-01
• Completion: 2020-05-01
• First posted: 2018-06-18
• Last updated: 2018-06-18