NCT05521802

A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma

A Phase Ib/II Study of CBM.BCMA Chimeric Antigen Receptor T Cell Product (C-CAR088) for Treating Patients With Relapsed or Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Shanghai AbelZeta Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label study to evaluate the safety and efficacy of C-CAR088 in patients with relapsed or refractory multiple myeloma. The phase Ib part of this study is to determine the recommended phase 2 dose (RP2D) of C-CAR088 in the targeted patient population.

Detailed description

The study includes the following sequential procedures: Screening, Apheresis and C-CAR088 manufacturing, Baseline testing, Lymphodepletion, C-CAR088 infusion, and Follow-up Visit. Two dose levels of C-CAR088 will be tested during the phase Ib part to determine RP2D, which will be further evaluated during the phase II part.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell	Autologous 2nd generation BCMA-directed CAR-T cells, single infusion intravenously

Timeline

• Start date: 2022-11-11
• Primary completion: 2024-07-01
• Completion: 2037-07-01
• First posted: 2022-08-30
• Last updated: 2023-03-24

Locations

1 site across 1 country: China