NCT06006741

Universal CAR-T Cells Targeting Multiple Myeloma

Universal CAR-T Cells for the Treatment of Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shenzhen Geno-Immune Medical Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the feasibility, safety and efficacy of universal CAR T cells targeting multiple myeloma. Another goal of the study is to learn more about the persistence and function of the universal CAR T cells in the body.

Detailed description

Multiple myeloma (MM) is a malignancy of the plasma cells, which remains a clinical challenge despite advanced therapeutic interventions including novel molecular therapies and stem cell transplantation (SCT). CAR-T therapy has proven to be a revolutionary treatment for hematological malignancies, but its manufacture is still limited by the high cost, and a long preparation time that is not conducive to timely treatment of patients. In addition, many MM patients suffer from long-term bone marrow suppression caused by tumor growth or prolonged and intense chemotherapies, resulting in exhaustion, aging and functional defects of autologous T cells, which substantially affect the quality of CAR-T cells and the clinical efficacy. The universal CAR-T cells could overcome many of the above problems. By using universal type of CAR-T cells, the product can be supplied off-the-shelf without being customized from individual patients. In addition, the immediate availability means that patients under severe bone marrow suppression may get a chance to be treated with CAR-T cells to achieve disease remission. In addition, those patients who suffer from long-term immunosuppression due to tumor microenvironment or myelosuppressive chemotherapy would have the option of treatment with the universal CAR-T cells. The purpose of this study is to assess the feasibility, safety and efficacy of several 4SCAR designs including BCMA, CD138, CD38 and CD19-specific universal CAR-T products targeting MM. Another goal is to learn more about the function of these universal CAR T cells and their persistency in the patients.

Conditions

• Multiple Myeloma in Remission

Interventions

Type	Name	Description
BIOLOGICAL	MM-specific universal CAR T cells	Infusion of MM-specific universal CAR T cells

Timeline

• Start date: 2023-10-31
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2023-08-23
• Last updated: 2023-10-12

Locations

1 site across 1 country: China