Universal CAR-T cells for treating multiple myeloma
Universal CAR-T Cells for the Treatment of Multiple Myeloma
This study is testing a new type of ready-made CAR T cell treatment for people with multiple myeloma who haven't fully recovered from previous therapies to see if it can help them.
Quick facts
| Phase | Phase 1 |
|---|---|
| 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, chemotherapy, CAR T |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT06006741 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility, safety, and efficacy of universal CAR T cells designed to target multiple myeloma. The approach utilizes off-the-shelf CAR T cells that can be administered without the need for individual customization, making them readily available for patients with severe bone marrow suppression. The study will assess various CAR designs targeting specific antigens associated with multiple myeloma, including BCMA, CD138, CD38, and CD19. By focusing on patients who have not achieved complete remission after prior therapies, this study seeks to provide a new treatment option for those with limited alternatives.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed multiple myeloma who have failed curative treatment options and are not eligible for stem cell transplantation.
Not a fit: Patients who have not experienced multiple myeloma relapse or those with early-stage disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a timely and effective option for patients with multiple myeloma who have exhausted other therapies.
How similar studies have performed: Other studies have shown promise with CAR T cell therapies in hematological malignancies, but the universal CAR T approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with confirmed multiple myeloma failed curative treatment options (including autologous or allogeneic SCT). 2. Complete remission (CR) cannot be achieved after at least 2 prior therapy regimens. 3. High risk MM in CR1 or CR2 and not eligible for SCT because of age or comorbid diseases. 4. Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year). 5. Relapsed after prior autologous or allogenic SCT with residual disease after at least 1 prior therapy and not eligible for allogeneic SCT. 6. Residual disease after primary therapy and not eligible for ASCT 7. Expected survival \> 12 weeks• Creatinine \< 2.5 mg/dl• ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal 8. Bilirubin \< 2.0 mg/dl 9. Any relapse after prior SCT is eligible regardless of other prior therapy 10. Adequate venous access for apheresis, and no other contraindications for leukapheresis 11. Voluntary informed consent is signed Exclusion Criteria: 1. Pregnant or lactating women 2. Uncontrolled active infection 3. Active hepatitis B or hepatitis C infection 4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. 5. Previous related CAR-T cell therapy 6. Any uncontrolled active medical disorder that would preclude participation 7. HIV infection
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Geno-Immune Medical Institute — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Lung-Ji Chang, PhD
- Email: c@szgimi.org
- Phone: 86-0755-8672 5195
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.