Clinical Study of CD38\CS1 Chimeric Antigen Receptor T Cells in the Treatment of Refractory/Recurrent Multiple Myeloma

NCT ID: NCT06574958

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-01-15

Brief Summary

The investigators developed a dual-target CAR-T targeting CD38 and CS1. Previous experimental results showed that the investigators double-target CAR-T not only had a good killing effect on CD38/CS1 double-positive tumor cells, but also had a high killing rate on CD38 or CS1 single-positive tumor cells. The investigators further study also found that the killing rate of the investigators dual-target CAR-T after mixing CD38 and CS1 monoyang tumor cells was over 80%. The advantage of the investigators dual-target CAR-T product is that the killing effect on single-yang, double-yang and single-yang mixed tumors is stable, and the killing rate is above 80% (see Figure 1). It has a wide killing range and can effectively reduce the phenomenon of tumor immune escape. Therefore, the investigators dual CAR products have good advantages and development potential.

Conditions

ORR,OS,PFS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

refractory or relapsed MM

Group Type: EXPERIMENTAL

CD38/CS1 injection

Intervention Type: BIOLOGICAL

Dosage form and specification: injection, 40mL/ dose, according to the number of positive cells 1×106/kg Properties: Colorless or slightly light white clear liquid Prescription composition: CD38/CS1 CAR T cells, 2.5% human blood albumin, 0.9% sodium chloride injection.

Administration mode: intravenous injection Storage condition: 2-8℃ for 8h Mechanism of action :38WP as a dual-target CAR T cell therapy, compared with single-target CAR T cell therapy, its advantage is that it can reduce antigen escape of tumor cells.

Interventions

CD38/CS1 injection

Dosage form and specification: injection, 40mL/ dose, according to the number of positive cells 1×106/kg Properties: Colorless or slightly light white clear liquid Prescription composition: CD38/CS1 CAR T cells, 2.5% human blood albumin, 0.9% sodium chloride injection.

Administration mode: intravenous injection Storage condition: 2-8℃ for 8h Mechanism of action :38WP as a dual-target CAR T cell therapy, compared with single-target CAR T cell therapy, its advantage is that it can reduce antigen escape of tumor cells.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Linlin Cui

professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Second Hospital of Shandong University

Shandong, Shandong, China

Countries

China

Other Identifiers

2024 CD38/CS1 T cell of MM

Identifier Type: -

Identifier Source: org_study_id