RecruitingPhase 2NCT05846737

BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT

Safety and Efficiency of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT: a Prospective, Single-arm, Single-center, Phase II Study.


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

20 participants

Start Date

May 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a open-label, single-center Phase 2 study to evaluate the efficacy and safety of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT. A total of 40 subjects will be enrolled into this study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a CAR-T cell therapy — a treatment where your own immune cells are reprogrammed to attack cancer — can help high-risk multiple myeloma (a blood cancer) patients who still have detectable cancer after their initial treatment and stem cell transplant. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with high-risk multiple myeloma - You have completed initial treatment (induction therapy) and a stem cell transplant - Tests show that cancer cells are still detectable in your bone marrow after transplant (called MRD positive) **You may NOT be eligible if...** - You have already been treated for multiple myeloma with a prior BCMA-targeted therapy - You have active infections, significant organ damage, or other serious health conditions - You have another active cancer - You are pregnant or breastfeeding 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 CAR-T

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


Locations(1)

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

Tianjin, Tianjin Municipality, China

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NCT05846737


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