Trials / Recruiting
RecruitingNCT07109323
Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM
Clinical Study on the Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation Combined With BCMA-CAR-T in the Treatment of Ultra-high Risk Multiple Myeloma
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of UHR-MM.
Detailed description
This study is a single center, prospective clinical study initiated by researchers to evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation combined with BCMA CAR-T in the treatment of ultra high risk multiple myeloma (UHR-MM).
Conditions
- Ultra High Risk mm (uhr-mm), 18-70 Years Old, Suitable for ASCT. And Meet Any of the Following uhr-mm Definitions
- Cytogenetics Ultra High Risk
- Primary Refractory
- Early Progression
- Plasma Cell Leukemia
- Non Paraosseous Extramedullary Infiltration
- R2-ISS-IV /MPSS-IV
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BCMA CART | Bcma-cart was reinfused at a dose of 1.0-2.0 × 10 \^ 6 / kg on day +3 (± 1 day) after autologous hematopoietic stem cell reinfusion. |
Timeline
- Start date
- 2025-03-03
- Primary completion
- 2028-03-02
- Completion
- 2030-03-02
- First posted
- 2025-08-07
- Last updated
- 2025-08-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07109323. Inclusion in this directory is not an endorsement.