NCT03943472

BCMA Chimeric Antigen Receptor Expressing T Cells Therapy for Relapsed/Refractory Multiple Myeloma

A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With Relapsed/Refractory Multiple Myeloma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hrain Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.

Detailed description

Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/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
BIOLOGICAL	Anti-BCMA CAR-T cells	Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
DRUG	Fludarabine	30mg/m2/d
DRUG	Cyclophosphamide	300mg/m2/d
DRUG	Immune inhibitors	Immune inhibitors

Timeline

• Start date: 2019-07-08
• Primary completion: 2021-11-01
• Completion: 2022-05-01
• First posted: 2019-05-09
• Last updated: 2021-08-31

Locations

1 site across 1 country: China