NCT03664661

BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma

a Single-center, One Arm, Open Clinical Study of BCMA Nanobody CAR-T Cell in Refractory/Relapsed Myeloma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma

Detailed description

There are no effective regimens for relapsed/refractory myeloma. BCMA express extensively in mature B cells and plasma cells. Myeloma cells express BCMA universally. BCMA signal pathway can induce plasma cell proliferation and survival, down-regulation of BCMA could control the progression of myeloma. The BCMA CAR used in this study consists of BCMA nanobody, CD8 hinge, transmembrane region and 4-1bb co-stimulation domain.

Conditions

• Relapsed/Refractory Myeloma

Interventions

Type	Name	Description
DRUG	BCMA nanobody CAR-T cells	step 1: Collect 50-100ml of peripheral blood for culture of BCMA nanobody CAR- T cells. step 2. After 72 hours, pretreated with FC regimen, details as follow Cyclophosphamide 600-800mg/m2 for 2 days Fludarabine 25-30mg/m2 for 3 days. step 3: After another 48 hours transfusion the cells back to the patients the numbers of infused CAR T cells are 5x106 /kg for the first 3 patients, 1.5x107 /kg for the second 3 patients and 4.5x107 /kg for the third 3 patients. After finishing this, another 6 patients will be enrolled for observation of efficacy.

Timeline

• Start date: 2018-04-11
• Primary completion: 2019-04-10
• Completion: 2020-04-30
• First posted: 2018-09-10
• Last updated: 2018-09-10

Locations

1 site across 1 country: China