Actively Recruiting
Clinical Study on the Safety and Efficacy of BCMA-CART±ASCT in Treating Young Multiple Myeloma Patients
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-02
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
Evaluate and compare the safety and efficacy of BCMA-CART ± ASCT in the treatment of newly diagnosed multiple myeloma (NDMM) in young patients
CONDITIONS
Official Title
Clinical Study on the Safety and Efficacy of BCMA-CART±ASCT in Treating Young Multiple Myeloma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 55 years
- Voluntary participation with signed informed consent
- Confirmed diagnosis of multiple myeloma by flow cytometry or immunohistochemistry
- Adequate organ function meeting specified laboratory criteria including bilirubin, liver enzymes, creatinine clearance, coagulation times, hemoglobin, neutrophil count, lymphocyte count, platelets, heart ejection fraction, and oxygen saturation
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Female participants of childbearing potential must have a negative pregnancy test and not be breastfeeding
- Use effective contraception for 24 months after cell infusion if of childbearing potential
You will not qualify if you...
- Allergy to any component of the cellular product
- Severe heart disease such as recent myocardial infarction, unstable angina, severe arrhythmia, severe non-ischemic cardiomyopathy, or advanced heart failure (NYHA class III or IV)
- Stroke or seizure within 6 months before enrollment
- Autoimmune diseases, immunodeficiency, or need for immunosuppressive therapy
- Other malignant tumors within 3 years except certain treated in situ cancers without ongoing treatment or recurrence
- Uncontrolled active infections
- Unstable systemic diseases including severe liver, kidney, or metabolic diseases requiring medication
- Positive tests for HBV DNA, HCV antibody and RNA, HIV antibody, syphilis, or CMV DNA within one week before lymphocyte collection
- Use of more than 5 mg/day prednisone or equivalent corticosteroids within one week before lymphocyte collection
- Previous CAR-T cell or genetically modified T cell therapy
- Prior BCMA-targeted therapy
- Live vaccine received within 4 weeks before enrollment
- History of alcoholism, drug abuse, psychiatric disorders, or other conditions deemed unsuitable by the investigator
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
Y
Yan Xu, MD
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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