Dendritic cell vaccines for treating multiple myeloma
Engineered Dendritic Cell Vaccines for Remission Maintenance in Multiple Myeloma Patients
This study is testing a new type of vaccine made from patients' own immune cells to see if it can help people with multiple myeloma stay in remission and prevent their cancer from coming back.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shenzhen Geno-Immune Medical Institute Academic / other |
| Drugs / interventions | CAR-T, immunotherapy |
| Locations | 2 sites (Shenzhen, Guangdong and 1 other locations) |
| Trial ID | NCT06435910 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility, safety, and efficacy of dendritic cell (DC) vaccines in patients with multiple myeloma or plasmacytoma who have achieved very good partial or complete remission. The approach involves using patient-specific tumor antigens to create immune-modified DC vaccines (DCvac) that enhance the body's immune response against myeloma cells. By boosting anti-myeloma immunity, the study seeks to prevent disease relapse in these patients. The trial is in Phase 1, focusing on establishing the safety and initial effectiveness of this innovative immunotherapy.
Who should consider this trial
Good fit: Ideal candidates are male and female patients with multiple myeloma or plasmacytoma who have achieved very good partial or complete remission after prior therapies.
Not a fit: Patients with uncontrolled active infections, HIV, active hepatitis B or C, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new immunotherapy option that helps maintain remission and prevent relapse in multiple myeloma patients.
How similar studies have performed: Previous studies have shown promise with similar immunotherapy approaches, particularly using CAR-T therapies, indicating potential for success with this novel DC vaccine strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female subjects with multiple myeloma or plasmacytoma * Very good partial or complete remission (CR) after prior combination therapies. * Expected survival \> 12 weeks * Adequate venous access for blood withdrawal or apheresis, and no other contraindications for blood withdrawal * Voluntary informed consent is given with willingness to continue follow up Exclusion Criteria: * Pregnant or lactating women * Uncontrolled active infection * HIV or active hepatitis B or hepatitis C infection * Concurrent use of systemic steroids; the use of inhaled steroids is not exclusionary
Where this trial is running
Shenzhen, Guangdong and 1 other locations
- Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (Recruiting)
- The Regional Hematology Center in Clinical Hospital No. 2 of the Ministry of Health — Vladivostok, Russia (Recruiting)
Study contacts
- Study coordinator: Lung-Ji Chang, ph.D
- Email: c@szgimi.org
- Phone: 86-0755-86725195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.