NCT03767725

Anti-BCMA or/and Anti-CD19 CART Cells Treatment of Relapsed Multiple Myeloma

Phase I Trial Study of Anti-BCMA (B-cell Maturation Antigen) or/and Anti-CD19 Chimeric Antigen Receptor T Cells (CART Cell) Treatment for the Patient of Relapsed Multiple Myeloma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shenzhen Second People's Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of BCMA CART cells in treating patients with BCMA positive multiple myeloma that have not respond to chemotherapy and autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT). B-cell maturation antigen (BCMA), a cell surface protein expressed on mutiple maloma cells, has emerged as a very selective antigen to be targeted in novel immunotherpy for MM. Targeting postulated CD19 positive myeloma stem cells with anti-CD19 CAR-T cells is a novel approach to MM therapy.

Detailed description

This is multi-center, phase I trial that studies the side effects and best dose of BCMA CART cells in treating patients with BCMA positive multiple myeloma that have not respond to chemotherapy and autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT). B-cell maturation antigen (BCMA), a cell surface protein expressed on mutiple maloma cells , has emerged as a very selective antigen to be targeted in novel immunotherpy for MM. Targeting postulated CD19+ myeloma stem cells with anti-CD19 CAR-T cells is a novel approach to MM therapy.

Conditions

• Multiple Myeloma in Relapse

Interventions

Type	Name	Description
BIOLOGICAL	Treatment	Phase 1 Clinical Study of The patients undergo leukapheresis. The patients then receive fludarabine and cyclophosphamide on days-5 to-3. Subjects will receive (0.6-60)x10E8 transduced CART cells as a split dose over three days as follows: Day 0, 10% fraction: (0.06-6)x10E8 CART19 cells, Day 1, 30% fraction: (0.18-18)x10E8 CART19 cells, Day 2, 60% fraction: (0.36-36)x10E8 CART cells.

Timeline

• Start date: 2018-06-02
• Primary completion: 2021-06-01
• Completion: 2021-09-01
• First posted: 2018-12-07
• Last updated: 2018-12-10

Locations

1 site across 1 country: China