NCT03093168

BCMA Chimeric Antigen Receptor Expressing T Cells in Multiple Myeloma

A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With BCMA-positive Multiple Myeloma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 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

Primary Objectives 1. To determine the feasibility ad safety of BCMA CAR-T cells in treating patients with multiple myeloma. 2. To determine in vivo dynamics and persistency of BCMA CAR-T cells. 3. To access the efficacy of BCMA CAR-T cells in patients with multiple myeloma. Secondary Objectives 1. To assess the bone marrow and tumor migration of BCMA CAR-T cells. 2. To investigate the tumor killing capability of BCMA CAR-T cells in vitro 3. To investigate the possibility of host immune response to the mouse derived BCMA scFv, and evaluate its correlation to CAR-T persistence. 4. To correlate the subsets and differentiation of BCMA CAR-T cells to observed anti-tumor efficacy.

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	dose: 25mg/m2/d
DRUG	Cyclophosphamide	Dose: 40mg/kg

Timeline

• Start date: 2017-02-15
• Primary completion: 2019-09-01
• Completion: 2020-02-01
• First posted: 2017-03-28
• Last updated: 2019-02-27

Locations

1 site across 1 country: China