Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT05913804

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

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-15

12

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

Sponsors

I

Institute of Hematology & Blood Diseases Hospital, China

Lead Sponsor

C

China Immunotech (Beijing) Biotechnology Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years, any gender
  • Diagnosed with relapsed or refractory multiple myeloma by IMWG 2014 criteria after at least 3 treatment lines including a proteasome inhibitor and immunomodulator
  • Documented disease progression during or within 12 months after the most recent antimyeloma therapy
  • Presence of measurable disease defined by serum M-protein 650.5 g/dL, urinary M-protein 65200 mg/24 hours, or abnormal serum free light chain levels
  • Good organ function
  • ECOG performance status of 0 or 1
  • Predicted survival time of at least 12 weeks
  • Agreement to use effective contraception during the trial and for 12 months after infusion
  • Voluntary informed consent and compliance with follow-up
Not Eligible

You will not qualify if you...

  • Allergy to any component of the cell product
  • CAR-T cell therapy or gene transduction treatment within 3 months prior to consent, except undetectable or very low CAR-T cells
  • Presence of plasma cell leukemia, Waldenstr�f6m's macroglobulinaemia, POEMS syndrome, or primary light chain amyloidosis
  • Recent cardiovascular or cerebrovascular diseases within 6 months including severe heart failure, myocardial infarction, unstable angina, cerebrovascular accident, severe arrhythmias, uncontrolled hypertension
  • Pulmonary embolism, deep vein thrombosis requiring anticoagulation, active lung disease, or pneumonia within 6 months
  • Positive tests for hepatitis B, hepatitis C, or syphilis
  • Known systemic lupus erythematosus, active autoimmune diseases, or immunodeficiency including HIV
  • Uncontrolled or uncured malignant tumors affecting survival, with some exceptions
  • History of central nervous system diseases such as seizures, stroke, dementia, or mental illness
  • Central nervous system involvement or symptoms
  • Recent organ transplantation or stem-cell transplantation within specified timeframes
  • Active graft-versus-host disease
  • Recent use of immunosuppressants, cytotoxic therapies, monoclonal antibodies, or immunomodulators within specified timeframes prior to apheresis
  • Live vaccination within 4 weeks before consent
  • History of mental illness or substance abuse
  • Pregnancy or lactation
  • Participation in other interventional clinical studies without proper drug washout
  • Other factors deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Tianjin, China

Actively Recruiting

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Research Team

G

Gang An, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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