NCT03879382

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

A Phase I Clinical Trial of Human CD19/BCMA Bispecific CAR-T Cell Therapy for Subjects With Relapsed and Refractory POMES Syndrome.

• Status: Unknown
• Phase: 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-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory POMES Syndrome.

Detailed description

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

Conditions

• POMES Syndrome
• Relapsed and Refractory POMES Syndrome

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: 2019-02-27
• Primary completion: 2020-08-30
• Completion: 2022-05-30
• First posted: 2019-03-18
• Last updated: 2021-08-06

Locations

1 site across 1 country: China