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
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Zhejiang University Academic / other |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05430945 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
- Study coordinator: He Huang, PhD
- Email: hehuangyu@126.com
- Phone: 86-13605714822
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
DC/MM fusion vaccine plus BCMA CAR-T for relapsed or refractory multiple myeloma
This trial will test whether adding a personalized DC/MM fusion vaccine (with GM‑CSF) to standard BCMA CAR‑T therapy helps people with relapsed or refractory multiple myeloma.
-
FT836 CAR T-cell Therapy with Daratumumab in relapsed/refractory multiple myeloma
This phase 1 study tests whether FT836 CAR T cells given with daratumumab are safe and show early signs of activity in adults with relapsed or refractory multiple myeloma who have had at least three prior therapies.
-
In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma
This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.
-
Selinexor with Carfilzomib, Isatuximab and Dexamethasone for relapsed or refractory multiple myeloma
This trial tests whether a four-drug combination can help adults with relapsed or refractory multiple myeloma when they've had at least one prior treatment.
-
Dual-target CD19/BCMA CAR-T therapy for relapsed or refractory multiple myeloma
This study will try a CAR-T treatment that targets both CD19 and BCMA to see if it helps people whose multiple myeloma has returned or not responded to prior therapies.
-
Talquetamab bridging therapy followed by ciltacabtagene autoleucel for relapsed/refractory multiple myeloma
This trial tests whether giving talquetamab as a temporary bridging treatment before cilta‑cel is safe and feasible for people with relapsed or refractory multiple myeloma who plan to receive CAR‑T therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.