RecruitingPhase 2NCT07106710

ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Ultra-High-Risk Multiple Myeloma

A Prospective, Single-Arm, Phase II Study of Autologous Stem Cell Transplantation Combined With BCMA CAR-T Therapy Followed by GPRC5D/CD3 Bispecific Antibody Maintenance in Transplant-Eligible Patients With Ultra-High-Risk Multiple Myeloma


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

30 participants

Start Date

Aug 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of autologous stem cell transplantation combined with BCMA CAR-T therapy followed by GPRC5D/CD3 bispecific antibody maintenance in transplant-eligible patients with ultra-high-risk multiple myeloma.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of stem cell transplant (ASCT), BCMA-targeting CAR-T cell therapy, and a maintenance drug (GPRC5D/CD3 BiTE) for newly diagnosed multiple myeloma patients who have very high-risk disease features. **You may be eligible if:** - You are between 18 and 70 years old - You have newly diagnosed multiple myeloma with measurable disease - You have at least one ultra-high-risk feature such as certain genetic abnormalities (like TP53 mutation, deletion of chromosome 17p, or multiple cytogenetic abnormalities) - You are fit enough to undergo a stem cell transplant - Your liver and kidney function are adequate **You may NOT be eligible if:** - You have already received treatment for multiple myeloma - You are not medically eligible for a stem cell transplant - Your organ function does not meet 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

PROCEDUREAutologous Hematopoietic Stem Cell Transplantation

Patients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection.

BIOLOGICALBCMA CAR-T

Patients will receive BCMA CAR-T single dose (3.0 x 10\^6 cells /kg) infusion 3 days after ASCT.

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 and continuing for at least 2 years


Locations(1)

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

Tianjin, Tianjin Municipality, China

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NCT07106710


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