NCT03674463

LCAR-B4822M-02 Cells in Treating Relapsed/Refractory (R/R) Multiple Myeloma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 73 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label, phase 1 study, to determine the safety and efficacy of LCAR-B4822M CAR-T cells in treating patients diagnosed with refractory/relapsed multiple myeloma (r/r MM).

Detailed description

Multiple myeloma (MM) is a usually incurable malignancy of plasma cells. Current therapies for multiple myeloma often cause remissions, but nearly all patients eventually relapse, there is an unmet clinical needs for these patients. B-cell maturation antigen (BCMA) is a protein expressed by normal plasma cells and the malignant plasma cells of multiple myeloma, and it was supposed to be a promising target for r/r MM.

Conditions

• Refractory or Relapsed Multiple Myeloma

Interventions

Type	Name	Description
DRUG	LCAR-B4822M CAR-T Cell Immunotherapy	Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the LCAR-B4822M CAR-T Cell Immunotherapy by intravenous injection.

Timeline

• Start date: 2018-07-26
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-09-17
• Last updated: 2018-12-14

Locations

1 site across 1 country: China