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

NCT06574958 | Active Not Recruiting Early Phase 1

• 1 other identifier: 2024 CD38/CS1 T cell of MM
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• ORR

  sCR、CR、VGPR、PR

  one year

Study Arms (1)

refractory or relapsed MM

EXPERIMENTAL

Biological: CD38/CS1 injection

Interventions

CD38/CS1 injection 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.

refractory or relapsed MM

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

Second Hospital of Shandong University

Shandong, Shandong, 250000, China

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medicine

Model Details: 10

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 28, 2024
• Study Start: April 30, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)