RecruitingPhase 1NCT07369895

Clinical Study of O&D-001 Injection in the Treatment of Relapsed or Refractory Multiple Myeloma

A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Chimeric Antigen Receptor T Cell (O&D-001) Injection Targeting BCMA and GPRC5D in the Treatment of Relapsed or Refractory Multiple Myeloma


Sponsor

O&D BioTech Group CO., Limited

Enrollment

18 participants

Start Date

Oct 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-center, open and dose-escalation clinical study to evaluate the safety, tolerability, PK/PD characteristics and preliminary efficacy of the investigational drug O\&D-001 injection in the treatment of relapsed or refractory multiple myeloma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental injection called O&D-001 in people with multiple myeloma (a type of blood cancer) that has come back or stopped responding to previous treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with multiple myeloma and your tumor cells test positive for BCMA or GPRC5D markers - You have already received at least 2 previous treatment regimens, including at least one proteasome inhibitor and one immunomodulatory drug - Your disease progressed during or within 12 months of your last treatment - You have measurable disease detectable in blood, urine, or bone marrow tests - Your physical functioning and blood counts are within acceptable levels **You may NOT be eligible if...** - You have serious heart, lung, kidney, or liver problems - You have an active infection or uncontrolled illness - You are pregnant or breastfeeding - You have received prior CAR-T cell therapy targeting BCMA or GPRC5D 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

BIOLOGICALChimeric antigen receptor T cell O&D-001 injection targeting BCMA and GPRC5D

Using the traditional 3+3 dose escalation method.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT07369895


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