RecruitingEarly Phase 1NCT06999031

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


Sponsor

The First Affiliated Hospital of Nanchang University

Enrollment

12 participants

Start Date

Sep 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called CG-105-12 for people with multiple myeloma — a cancer of the blood — that has come back or stopped responding to other treatments. **You may be eligible if...** - You are 18–75 years old - You have had at least 3 prior treatments for multiple myeloma (including both a proteasome inhibitor and an immunomodulatory drug) - Your myeloma has come back or is no longer responding to treatment - Lab tests show your cancer cells carry a protein called BCMA - You have never received CAR-T cell therapy targeting BCMA before - Your overall health is reasonably good (able to carry out daily activities) **You may NOT be eligible if...** - You have active hepatitis B, hepatitis C, HIV, or syphilis - You have had certain other cancers in the past 5 years - You have had an organ transplant or prior bone marrow transplant from a donor - You have uncontrolled infections, severe heart disease, or uncontrolled diabetes - You are pregnant or breastfeeding - You have had certain recent treatments (e.g., recent chemotherapy, steroids, or live vaccines) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBCMA-Targeted Chimeric Antigen Receptor Autologous T-cell

Chimeric Antigen Receptor Autologous T-cell


Locations(1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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NCT06999031


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