NCT05008536

Anti-BCMA CAR-NK Cell Therapy for the Relapsed or Refractory Multiple Myeloma

Phase I Study to Evaluate the Safety and Effectiveness of Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to infuse BCMA CAR-NK cells（Umbilical \& Cord Blood (CB) Derived CAR-Engineered NK Cells） to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.

Conditions

• Multiple Myeloma, Refractory

Interventions

Type	Name	Description
BIOLOGICAL	Anti-BCMA CAR-NK Cells	1-3×10\^6 /KG, 3-6×10\^6 /KG, 0.6-1.2×10\^7/KG Treatment follows a lymphodepletion
DRUG	Fludarabine	recommendation: 30mg/m2 (D-5\~D-3),determined by tumor burden at baseline.
DRUG	Cytoxan	recommendation: 300-500mg/m2 (D-5\~D-3),determined by tumor burden at baseline.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-09-01
• Completion: 2023-09-01
• First posted: 2021-08-17
• Last updated: 2021-11-23

Locations

1 site across 1 country: China