Clinical trial No longer in our active list Early Phase 1 Interventional

BCMA-targeted CAR-T cell therapy for multiple myeloma

Official title: Clinical Trial for the Safety and Efficacy of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

Run by Zhejiang University · NCT05430945 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing a new CAR-T cell therapy aimed at treating patients with relapsed or hard-to-treat multiple myeloma to see how safe and effective it is.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
SexAll
Enrollment100 (estimated)
SponsorZhejiang University
Academic / other
Drugs / interventionsCAR-T, chemotherapy
Locations1 site (Hangzhou, Zhejiang)
Trial IDNCT05430945 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with BCMA positive relapsed or refractory multiple myeloma who have not responded to previous treatments.

Probably not a fit

Patients with severe heart conditions or significant neurological issues may not benefit from this therapy.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of BCMA-targeted CAR-T cell therapy in patients with relapsed or refractory multiple myeloma. A total of 100 patients will receive this innovative treatment, which has shown promise in previous studies. The trial aims to gather more data on the effectiveness and safety of this therapy, particularly focusing on rare and delayed complications. By expanding the sample size, the study seeks to provide a comprehensive understanding of the treatment's impact on this challenging condition.

Why it matters

Potential benefit: If successful, this therapy could offer a new treatment option for patients with difficult-to-treat multiple myeloma.

How similar studies have gone: Previous studies have shown promising results with BCMA-targeted therapies, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 1. Histologically confirmed diagnosis of multiple myeloma (MM):

  1. Patients with BCMA positive relapsed/refractory MM;
  2. Relapsed after hematopoietic stem cell transplantation;
  3. Cases with recurrent positive minimal residual disease;
  4. Repeated MRD(+) refractory resistant cases
  5. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.

     2. Anticipated survival time more than 12 weeks; 3. Transplant patients, regardless of their previous treatment, are eligible after relapse; 4. Those who voluntarily participated in this trial and provided informed consent.

     Exclusion Criteria:
* Subjects with any of the following exclusion criteria were not eligible for this trial:

  1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  3. Pregnant (or lactating) women;
  4. With a graft-versus-host response, immunosuppressants are required;
  5. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  6. Active infection of hepatitis B virus or hepatitis C virus;
  7. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
  8. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
  9. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
  10. Other uncontrolled diseases that were not suitable for this trial;
  11. Patients with HIV infection;
  12. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Where it's running

  • The First Affiliated Hospital, Medical College, Zhejiang University
    Hangzhou, Zhejiang, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.