NCT05594797

Human BCMA Targeted T Cells Injection（BCMA CAR-T）for Subjects With R/R MM

A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection Therapy for Relapsed/Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hrain Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection（BCMA CAR-T） Therapy for R/R MM. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.

Detailed description

Participants with relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, Computedtomography （CT）/Magnetic Resonance Imaging(MRI)/Positron Emission Tomography（PET）, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Human BCMA Targeted T Cells Injection	A single dose of predetermined level CAR-positive T cells will be infused.

Timeline

• Start date: 2022-07-12
• Primary completion: 2025-07-31
• Completion: 2027-07-31
• First posted: 2022-10-26
• Last updated: 2022-12-09

Locations

2 sites across 1 country: China