NCT04601935

A Single-center Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of a BCMA-targeted Universal LCAR-BCX Cells in Patients With Relapsed/Refractory Multiple Myeloma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Weijun Fu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, single-center, open-label dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCX cells in subjects with relapsed/refractory multiple myeloma

Conditions

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	LCAR-BCX cells product	In this study, LCAR-BCX CAR+ cells will be evaluated at 5 dose levels including 0.25 × 10\^6 cells/kg, 0.5 × 10\^6 cells/kg, 1.0 × 10\^6 cells/kg, 2.0 × 10\^6 cells/kg, and 4.0 × 10\^6 cells/kg, with 0.25 × 10\^6 cells/kg as the starting dose, to determine RP2D for LCAR-BCX cell therapy

Timeline

• Start date: 2020-10-09
• Primary completion: 2023-01-01
• Completion: 2024-10-01
• First posted: 2020-10-26
• Last updated: 2021-11-02

Locations

1 site across 1 country: China