RecruitingPhase 1NCT05913804

YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma

An Exploratory Clinical Study on the Safety and Efficacy of YTS104 Cell Injection in the Treatment of Relapsed or Refractory Multiple Myeloma


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

12 participants

Start Date

Jun 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-center, single-arm, open-label phase I clinical study to determine the safety and efficacy of relapsed or refractory multiple myeloma subjects


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing YTS104, a new CAR-T cell therapy (where your immune cells are reprogrammed to attack cancer), for people with multiple myeloma (a blood cancer) that has returned or stopped responding to other treatments. **You may be eligible if...** - You are 18–75 years old - You have relapsed or refractory multiple myeloma after at least 3 prior treatment lines - Prior treatments must have included a proteasome inhibitor (like bortezomib) and an immunomodulatory drug (like lenalidomide) - You have measurable disease - You have adequate organ function **You may NOT be eligible if...** - You have had a prior CAR-T cell therapy - You have active brain involvement from myeloma - You have serious heart, liver, or kidney problems - 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

BIOLOGICALYTS104 Cells injection

YTS104 Cell injection(LILRB4 dual STAR-T Cell Injection/BCMA LILRB4 Dual STAR-T Cell Injection)) is a new STAR-T cell transfected by lentivirus.The study required that lymphocytes were collected from the subjects and cultured for 2-3 weeks to obtain YTS104 cell injection. Subjects were treated with fludarabine and cyclophosphamide chemotherapy prior to reinfusion, followed by a 2-day rest period before cell infusion.


Locations(1)

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

Tianjin, China

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NCT05913804


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