NCT02954445

A Clinical Research of BCMA-Targeted CAR-T in B Cell Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Southwest Hospital, China · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of this study is to explore the therapeutic effect of BCMA-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of B-cell derived malignancies.

Detailed description

B-cell maturation antigen(BCMA) is preferentially expressed in mature B lymphocytes as well as in B-cell derived leukemia, lymphomas, and multiple myeloma. Despite of the fact that CD19-targeted CAR-T can re-induce remissions for many patients with relapsed and refractory B cell malignancies, a part of those patients will relapse with CD19-negative malignancies. To explore a rescue for those with CD19-negative B cell malignancies, this trial is designed and conducted to test the safety and effect of BCMA-targeted CAR-T.

Conditions

• Leukemia
• Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Anti-BCMA-CAR-transduced T cells	The first 3 enrolled patients will receive autologous-derived BCMA-targeted CAR-T cells on day 1, 2 and 3 with respective 10%, 30% and 60% of the total expected dosage after receiving lymphodepleting chemotherapy. If the 3 patients don't display severe toxicity, the next patients enrolled will get infused in 2 days with respective 40% and 60% total dosage.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-10-01
• Completion: 2020-10-01
• First posted: 2016-11-03
• Last updated: 2019-06-25

Locations

1 site across 1 country: China