RecruitingPhase 2NCT07106736

MRD-Adaptive Guided Immunotherapy With CAR-T for Transplant-Ineligible Patients With Multiple Myeloma

A Prospective, Open-Label, Single-Center Clinical Study of a Fully Immunotherapy-Based Strategy Driven by MRD-Guided Dynamic Risk Stratification in Transplant-Ineligible Newly Diagnosed Multiple Myeloma


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

60 participants

Start Date

Aug 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-center, clinical study to evaluate the efficacy and safety of a fully immunotherapy-based strategy guided by MRD-driven dynamic risk stratification in transplant-ineligible patients with newly diagnosed multiple myeloma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy approach guided by MRD (minimal residual disease) monitoring for multiple myeloma patients who cannot undergo a stem cell transplant. MRD measures tiny amounts of leftover cancer — the idea is to tailor immunotherapy based on how much disease remains. **You may be eligible if:** - You are between 18 and 75 years old - You have newly diagnosed multiple myeloma - You are NOT eligible for a stem cell transplant (for example, due to age 65+, poor performance status, or failed stem cell collection) - Your cancer cells test positive for BCMA and GPRC5D - Your liver and kidney function are adequate **You may NOT be eligible if:** - You are eligible for a stem cell transplant and willing to undergo one - Your cancer does not express BCMA or GPRC5D - Your organ function does not meet the study's requirements 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 CAR-T

Patients will receive single-dose infusion of autologous BCMA-directed CAR-T cellsBCMA CAR-T single dose (3.0 x 10\^6 cells /kg).

DRUGGPRC5D/CD3 BiTEs

Patients will receive GPRC5D/CD3 BiTEs maintenance therapy at a dose of 54 μg/kg every 4 weeks, starting 3 months after BCMA CAR-T infusion.


Locations(1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT07106736


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