RecruitingNot ApplicableNCT06793475

Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease

Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease: A Prospective, Single-Arm, Multicenter, Open-Label Study


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

20 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of aponermin-based bridging therapy prior to CAR-T infusion in relapsed/refractory multiple myeloma patients with extramedullary disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called aponermin as a bridge therapy — used to control the cancer while waiting for CAR-T cell treatment to be prepared — in multiple myeloma patients whose cancer has spread outside the bone marrow to soft tissues (called extramedullary disease). **You may be eligible if...** - You are 18 or older with multiple myeloma that has come back or stopped responding to prior treatment - Your cancer has spread to soft tissue outside bones, with tumors at least 2 cm in size - You are planning to receive CAR-T cell therapy - Your general health and organ function are adequate **You may NOT be eligible if...** - You have an active infection - You test positive for HIV, hepatitis B, or hepatitis C - Your liver or kidney function is significantly impaired 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

BIOLOGICALanti-BCMA/GPRC5D bispecific CAR-T

Autologous BCMA/GPRC5D bispecific CAR-T cells, infusion intravenously at a target dose of 2-4 x 10\^6 anti-BCMA/GPRC5D bispecific CAR-T cells/kg.

DRUGApornemin

Apornemin 10mg/kg will be administered by i.v. infusion. Apornemin will be administered on Days 1-5, 15-19 during bridging therapy, and on Days 1-5 every 28-day cycle during maintanance treatment.

DRUGCarfilzomib

Carfilzomib 27mg/m\^2 will be administered by i.v. on Days 1,2,8,9 during bridging therapy.

DRUGThalidomide

Thalidomide (150mg/d) will be administered by p.o. on Days 1-14 during bridging therapy, and Days 1-28 every 28-day cycle during maintanance treatment.

DRUGDexamethasone

Dexamethasone (20mg/d) will be administered by i.v. or p.o. on Days 1-4,8,9 during bridging therapy.


Locations(2)

Beijing Gobroad Boren Hospital

Beijing, China

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

Tianjin, China

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NCT06793475


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