NCT04194931

Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma

Study Evaluating the Safety and Efficacy With Sequential Infusion of Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or refractory multiple myeloma.

Detailed description

CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory multiple myeloma by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to preliminary explore the safety, tolerability and cellular pharmacokinetics of Anti-BCMA and Anti-CD19 CAR-T cells in the treatment of relapsed or refractory multiple myeloma.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Autologous BCMA CAR-T cells and CD19 CAR-T cells	Autologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5\*10\^6 cells/kg body weight,separately.

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-12-11
• Last updated: 2019-12-11

Locations

1 site across 1 country: China