NCT03706547

Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM

Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peng Liu · 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-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.

Detailed description

Primary Objectives 1\. To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with BCMA-positive multiple myeloma. Secondary Objectives 1. To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma. 2. To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.

Conditions

• Multiple Myeloma in Relapse
• Multiple Myeloma Progression

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19/BCMA CAR-T cells	Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs
DRUG	Fludarabine	30mg/m2/d
DRUG	Cyclophosphamide	300mg/m2/d

Timeline

• Start date: 2018-10-30
• Primary completion: 2020-07-01
• Completion: 2021-12-01
• First posted: 2018-10-16
• Last updated: 2018-10-16

Locations

1 site across 1 country: China