BCMA-targeted CAR-T cell therapy for multiple myeloma

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

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
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: CAR-T, chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05430945 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

Eligibility 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 this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Study coordinator: He Huang, PhD

Conditions Relapse Multiple Myeloma; Refractory Multiple Myeloma; multiple myeloma; CAR T-cell therapy; BCMA