Combination CAR-T cell therapy for multiple myeloma and plasmacytoma
Frontline Management of High-Risk Multiple Myeloma or Plasmacytoma With BCMA and GPRC5D Combination CAR-T Cell Therapy
This study is testing a new combination CAR-T cell therapy for people with high-risk multiple myeloma or plasmacytoma to see if it can help them achieve better treatment results.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (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 | NCT06429150 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a combination CAR-T cell therapy targeting multiple antigens in patients with high-risk multiple myeloma or plasmacytoma. The study aims to achieve strict complete remission and assess the persistence and function of the CAR-T cells in the body. By targeting both BCMA and GPRC5D, the trial seeks to explore a synergistic therapeutic approach that could improve treatment outcomes for patients who have limited options. Participants will undergo leukapheresis to collect cells for CAR-T therapy, followed by monitoring for safety and effectiveness.
Who should consider this trial
Good fit: Ideal candidates include male and female patients with multiple myeloma or plasmacytoma who are in strict complete remission and have an expected survival of more than 12 weeks.
Not a fit: Patients who are pregnant, have uncontrolled infections, or active viral infections such as HIV or hepatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a more effective treatment option for patients with high-risk multiple myeloma or plasmacytoma.
How similar studies have performed: Other studies targeting BCMA and GPRC5D have shown promise, indicating that this approach may lead to significant advancements in treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female subjects with multiple myeloma or plasmacytoma * Strictly complete remission (sCR) is a treatment goal * Expected survival \> 12 weeks * After prior auto-SCT is eligible regardless of other prior therapies * Adequate venous access for apheresis, and no other contraindications for leukapheresis * Voluntary informed consent is given and commitment to continued follow-up Exclusion Criteria: * Pregnant or lactating women * Uncontrolled active infection * Active HIV, hepatitis B or hepatitis C infection * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. * Any medical conditions that may preclude participation
Where this trial is running
Shenzhen, Guangdong and 1 other locations
- Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (Recruiting)
- Hematologist of 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.