Actively Recruiting
Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-07
50
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
H
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of UHR-MM.
CONDITIONS
Official Title
Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ultra high risk multiple myeloma (UHR-MM), age 18 to 70 years, suitable for autologous stem cell transplantation (ASCT)
- Meet any of the following UHR-MM definitions: cytogenetic ultra-high risk features, primary refractory disease, early progression, plasma cell leukemia, non-paraosseous extramedullary infiltration, or R2-ISS-IV/MPSS-IV staging
- Voluntarily agree to participate and sign informed consent
- Adequate organ function including: serum total bilirubin ≤1.5 times upper limit of normal (ULN); ALT and AST ≤2.5 times ULN; creatinine clearance ≥40 ml/min; coagulation tests within specified limits; hemoglobin ≥60 g/L; neutrophils ≥1.0 × 10^9/L without growth factors within 7 days; lymphocytes ≥0.5 × 10^9/L; platelets ≥50 × 10^9/L without transfusion within 7 days; left ventricular ejection fraction ≥45%; blood oxygen saturation ≥92%
- ECOG performance status of 0-1
- Estimated survival of at least 3 months
- Negative pregnancy test for fertile females and not breastfeeding
- Use effective contraception for 24 months after cell infusion
You will not qualify if you...
- History of allergy to any component in the cell products
- Serious heart disease, including recent myocardial infarction, unstable angina, severe arrhythmia, severe cardiomyopathy, or congestive heart failure NYHA class III or IV
- Previous autologous or allogeneic hematopoietic stem cell transplantation
- Stroke or seizure within 6 months before enrollment
- Autoimmune disease, immune deficiency, or conditions requiring immunosuppressant treatment
- Malignant tumors other than multiple myeloma within 3 years, except certain treated cancers without recurrence
- Uncontrolled active infection
- Unstable serious liver, kidney, or metabolic diseases requiring drug treatment
- Positive for certain infections including hepatitis B, hepatitis C, HIV, syphilis, or CMV within 1 week before lymphocyte collection
- Use of more than 5 mg/day prednisone or equivalent corticosteroids within 1 week before lymphocyte collection
- Previous use of CAR-T cell therapies or BCMA-targeted therapy
- Live vaccination within 4 weeks before enrollment
- History of alcohol or drug abuse or mental illness
- Other conditions deemed inappropriate by researchers for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
D
Dehui Zou
CONTACT
Y
Yan Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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