RecruitingPhase 1Phase 2NCT07109323

Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM

Clinical Study on the Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation Combined With BCMA-CAR-T in the Treatment of Ultra-high Risk Multiple Myeloma


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

50 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of UHR-MM.


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) and BCMA-targeting CAR-T cell therapy for patients with ultra-high-risk multiple myeloma (UHR-MM) — a particularly aggressive form of this blood cancer. The goal is to see if this intensive combination can achieve better and longer-lasting responses. **You may be eligible if:** - You are between 18 and 70 years old and fit enough for a stem cell transplant - You have ultra-high-risk multiple myeloma, defined by specific high-risk genetic features (such as del(17p), TP53 mutation, or multiple cytogenetic abnormalities), primary refractory disease, or early progression after initial treatment - Your cancer has measurable disease by standard lab tests **You may NOT be eligible if:** - You do not meet the definition of ultra-high-risk multiple myeloma - You are not healthy enough 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

DRUGBCMA CART

Bcma-cart was reinfused at a dose of 1.0-2.0 × 10 \^ 6 / kg on day +3 (± 1 day) after autologous hematopoietic stem cell reinfusion.


Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

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NCT07109323


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