NCT06999031

A Study to Evaluate CG-105-12 in Patients With Relapsed/Refractory Multiple Myeloma

An Exploratory Clinical Study on the Safety and Efficacy of Autologous T Cell Injection Targeting BCMA Chimeric Antigen Receptor (CG-105-12) in the Treatment of Patients With Relapsed / Refractory Multiple Myeloma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: The First Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-centre, single-arm, open-label, dose-escalation exploratory study with single-dose administration. Its objective is to evaluate the safety, tolerability, dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-105-12 in the participants with BCMA-positive relapsed/refractory multiple myeloma who previously received adequate but uneffective standard treatments.

Detailed description

This study is a single-centre, open-label, dose-escalation exploratory clinical trial. Its objective is to evaluate the safety, tolerability, recommended dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-105-12 infused in participants with BCMA-positive relapsed/refractory multiple myeloma who previously received adequate but uneffective standard treatments.. The study will be carried out in accordance with the protocol. Due to the early-stage of the exploratory clinical research,, the anticipated sample size for the three dose groups is 7-12 participants.

Conditions

• Relapsed/Refractory
• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell	Chimeric Antigen Receptor Autologous T-cell

Timeline

• Start date: 2024-09-05
• Primary completion: 2026-04-05
• Completion: 2027-09-30
• First posted: 2025-05-31
• Last updated: 2025-05-31

Locations

1 site across 1 country: China