NCT07169500 Clinical Study on the Safety and Efficacy of BCMA-CART±ASCT in Treating Young Multiple Myeloma Patients
| NCT ID | NCT07169500 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2028-03-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2025-03-03 with a primary completion date of 2028-03-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluate and compare the safety and efficacy of BCMA-CART ± ASCT in the treatment of newly diagnosed multiple myeloma (NDMM) in young patients
Eligibility Criteria
Inclusion Criteria： Young female, 18-55 years old; 1. Subjects voluntarily participate in the study and sign the informed consent form (ICF) themselves or through their legal guardian; 2. Confirmed diagnosis of multiple myeloma through flow cytometry or immunohistochemistry; 3. Subjects must have adequate organ function and meet all of the following test results: * Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN * Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥ 40 ml/min * Prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) \< 1.5 × ULN, international normalized ratio (INR) \< 1.5 × ULN * Hemoglobin (Hb) ≥ 60 g/L * Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L (no granulocyte colony-stimulating factor \[G-CSF\] or other growth factors received within 7 days prior to screening laboratory tests) * Absolute lymphocyte count (ALC) ≥ 0.5 × 10\^9/L * Platelets (PLT) ≥ 50 × 10\^9/L (no platelet transfusion received within 7 days prior to screening laboratory tests) * Left ventricular ejection fraction (LVEF) ≥ 45% * Blood oxygen saturation (SpO2) ≥ 92% 4. ECOG score of 0-1, see Appendix 5 for ECOG scoring; 5. Expected survival ≥ 3 months; 6. Female participants of childbearing potential must have a negative pregnancy test and not be breastfeeding; female or male participants of childbearing potential must use effective contraceptive methods or devices for 24 months after cell infusion. Exclusion Criteria: 1. History of allergy to any component of the cellular product; 2. Severe heart disease, including but not limited to: * Myocardial infarction, coronary angioplasty, or stent implantation within 6 months prior to signing the ICF * Unstable angina * Severe arrhythmia * History of severe non-ischemic cardiomyopathy * Congestive heart failure (New York Heart Association \[NYHA\] class III or IV), NYHA scores are in Appendix 2 3. Stroke or seizure within 6 months prior to signing the ICF; 4. Autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive therapy; 5. Malignant tumors other than multiple myeloma within 3 years prior to signing the ICF, except fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ of the breast after radical surgery, and other in situ cancers at other sites one year after radical surgery, provided there is no ongoing treatment and no signs of recurrence during the screening period; 6. Presence of uncontrolled active infection; 7. Unstable systemic diseases as judged by the investigator, including but not limited to severe liver, kidney, or metabolic diseases requiring medication. 8. Within one week before lymphocyte collection, the storage device falls under any of the following conditions: * Peripheral blood hepatitis B virus (HBV) DNA test value is above the detection limit * Hepatitis C virus (HCV) antibody positive and peripheral HCV-RNA positive * Human immunodeficiency virus (HIV) antibody positive * Syphilis antigen or antibody positive * CMV-DNA positive 9. Within one week before lymphocyte collection, use of more than 5 mg/day of prednisone (or an equivalent dose of other corticosteroids); 10. Prior use of any CAR-T cell products or other genetically modified T cell therapies; 11. Prior BCMA-targeted therapy; 12. Vaccination with a live vaccine within 4 weeks before signing the ICF; 13. History of alcoholism, drug abuse, or psychiatric disorders; Other conditions that the investigator deems unsuitable for participation in this study.
Contact & Investigator
Yan Xu, MD
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT07169500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07169500 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07169500 currently recruiting?
Yes, NCT07169500 is actively recruiting participants. Contact the research team at xuyan1@ihcams.ac.cn for enrollment information.
Where is the NCT07169500 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07169500 clinical trial?
NCT07169500 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Yan Xu, MD at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 50 participants.