NCT05150522

B Cell Maturation Antigen Targeted CAR-T Cells in Treatment With Relapsed and Refractory Multiple Myeloma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shenzhen University General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

For the treatment of relapsed and refractory MM, the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma pointed out that relapsed MM is highly heterogeneous, and individualized evaluation of relapsed patients is required to determine the treatment time. Patients with biochemical recurrence with only elevated M protein do not need immediate treatment, only regular follow-up visits. For patients with CRAB manifestations or rapid biochemical relapse, treatment needs to be initiated immediately. Patients who relapse within 6 months can switch to a drug combination with other mechanisms of action; patients who relapse within 6 to 12 months should first switch to a drug combination with other mechanisms of action, or they can be retreated with the original drug; 12 months Patients with the above recurrence can use the original regimen to re-induction therapy, or switch to a drug regimen with other mechanisms of action. Bortezomib, lenalidomide, and thalidomide are currently the key drugs for the treatment of relapsed MM in China. Patients with suitable conditions should undergo autologous hematopoietic stem cell transplantation, while allogeneic hematopoietic stem cell transplantation is rarely used because of higher transplant-related mortality.

Detailed description

For the treatment of relapsed and refractory MM, the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma pointed out that relapsed MM is highly heterogeneous, and individualized evaluation of relapsed patients is required to determine the treatment time. Patients with biochemical recurrence with only elevated M protein do not need immediate treatment, only regular follow-up visits. For patients with CRAB manifestations or rapid biochemical relapse, treatment needs to be initiated immediately. Patients who relapse within 6 months can switch to a drug combination with other mechanisms of action; patients who relapse within 6 to 12 months should first switch to a drug combination with other mechanisms of action, or they can be retreated with the original drug; 12 months Patients with the above recurrence can use the original regimen to re-induction therapy, or switch to a drug regimen with other mechanisms of action. Bortezomib, lenalidomide, and thalidomide are currently the key drugs for the treatment of relapsed MM in China. Patients with suitable conditions should undergo autologous hematopoietic stem cell transplantation, while allogeneic hematopoietic stem cell transplantation is rarely used because of higher transplant-related mortality. BCMA (B cell maturation antigen), also called TNFRSF17 (TNF receptor superfamily member 17, TNF ligand superfamily member 17), is mainly expressed in plasma cells and mature B lymphocytes, is basically undetectable in other normal human cells . BCMA is the most selectively expressed receptor on the MM cell line, and its expression gradually increases with the differentiation of B cells, and it also gradually increases in the disease process of multiple myeloma. Experiments in mice found that overexpression of BCMA can induce protein kinase B, mitogen-activated protein kinase (MAPK) and nuclear factor kB (nuclear factors kB, NF-kB) signal cascade to enhance the growth and survival of MM cells, thereby Speed up the progress of MM; and down-regulation of BCMA expression can significantly reduce the formation of MM colonies and reduce the survival rate of MM cells. BCMA has become an ideal antigen target for MM because of its high selective expression in MM cell lines and its important role in normal and malignant late B cell proliferation, differentiation and antibody production.

Conditions

• Multiple Myeloma
• Relapse Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	BCMA CAR-T cells	BCMA CAR-T cells infusion

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2021-12-09
• Last updated: 2021-12-09

Locations

1 site across 1 country: China