NCT07477912

Anti BCMA CAR- T Cell Therapy for Adults With Relapsed or Refractory Multiple Myeloma

Phase I/II Open-label Study Evaluating The Safety And Efficacy of Anti BCMA CAR-T Cell Therapy in Adults With R/ R Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The mail purpose of this study is to estimate the safety and the efficacy of anti-BCMA CAR- T cell immunotherapy for adults with relapsed or refractory multiple myeloma

Detailed description

Locally manufactured second generation autologous humanized anti-BCMA cells are used for immunotherapy. Protocol treatment includes leukapheresis in order to harvest T cells, lymphodepleting conditioning (fludarabine 30 mg/m2+ cyclophosphamide 300 mg/2(days -5-3)) followed by one anti (day 0) BCMA CAR-T cell infusion. The Main research objectives of the Phase I: To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, p arkinsonism and cytopenias) and tolerability. The Secondary research objectives of the Phase I: To explore the pharmacokinetics of CAR-T cells. The Main research objectives of the Phase II: Overall response rate, including partial response (PR), very good partial response (VGPR), complete response (CR) and stringent complete response(sCR) rates. The Secondary research objectives of the Phase II: Duration of response (DOR). Progression-free survival rates. Overall survival rates.

Conditions

• Multiple Myeloma Refractory

Interventions

Type	Name	Description
BIOLOGICAL	anti BCMA CAR-T cells	Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 250 x 10⁶ anti BCMA CAR-T cells

Timeline

• Start date: 2025-02-01
• Primary completion: 2028-02-01
• Completion: 2030-02-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: Belarus