NCT07249073 CAR19-BCMA Dual-target CAR-T in the Treatment of Relapsed / Refractory Multiple Myeloma
| NCT ID | NCT07249073 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2025-03-28 |
| Primary Completion | 2028-03-27 |
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 9 participants in total. It began in 2025-03-28 with a primary completion date of 2028-03-27.
⚠ 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
1. Objective to evaluate the safety and tolerability of CAR19-BCMA dual-target CAR-T in the treatment of relapsed / refractory multiple myeloma. 2. To determine the maximum tolerated dose (MTD) of car19-bcma dual target car-t in the treatment of relapsed / refractory multiple myeloma.
Eligibility Criteria
Inclusion Criteria: Subjects must satisfy all the following criteria to be enrolled in the study: 1\. With Subjects' consent and signed informed consent, Subjects are willing and able to follow the planned visit, study treatment, laboratory examination and other test procedures; 2. Patients with relapsed / refractory multiple myeloma according to clinical diagnosis: 1. The expression of BCMA and / or CD19 in myeloma cells was positive confimed by flow cytometry or immunohistochemistry; 2. Patients with relapsed / refractory multiple myeloma who have received at least 1 line treatment (including proteasome inhibitors (PI), immunomodulatory drugs (IMID), CD38 mAb) or are resistant to proteasome inhibitors and / or immunomodulatory agents and / or CD38 mAb in the past. 3\. Age 18-70 years old, both male and female; 4. Subjects with physical fitness status of 0-2 in the Eastern Cooperative Oncology Group (ECOG) score; 5. The estimated survival time from the date of signing informed consent is more than 3 months; 6. Hgb ≥ 60g/L (transfusible); 7. Liver and kidney function and cardiopulmonary function meet the following requirements: 1. Creatinine ≤ 2 × ULN; 2. Left ventricular ejection fraction ≥ 50%; 3. Blood oxygen saturation \>90%; 4. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; 8. Subjects with pregnancy plans must agree to take contraception before enrollment in the study and after six months of study duration; The investigator should be informed immediately if the subject is pregnant or suspected of pregnancy. \- Exclusion Criteria: If any of the following criteria is met, you cannot be enrolled: 1\. There were severe cardiac insufficiency and left ventricular ejection fraction \<50%; 2. Have a history of severe lung function impairment disease; 3. Combined with other advanced malignant tumors; 4. It was complicated with serious infection and could not be effectively controlled; 5. Complicated with severe autoimmune disease or innate immune deficiency; 6. Active hepatitis (hepatitis B virus deoxyribonucleic acid \[hbv-dna\] or hepatitis C virus ribonucleic acid \[hcv-rna\] test results are higher than the lower limit of detection); 7. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), or syphilis infection; 8. Have a history of severe allergy to biological products (including antibiotics); 9. One month after immunosuppressant withdrawal, patients with acute graft-versus-host response (GVHD) after allogeneic hematopoietic stem cell transplantation still exist; 10. There are other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator believes are not suitable for participating in this study; 11. Female patients (patients with fertility) are in pregnancy or lactation. Note: severe infection: refers to the infection with uncontrolled sepsis or infection focus, which can be enrolled after infection control. \-
Contact & Investigator
Yan Xu, MD
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT07249073 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 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 NCT07249073 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 NCT07249073 currently recruiting?
Yes, NCT07249073 is actively recruiting participants. Contact the research team at ec@ihcams.ac.cn for enrollment information.
Where is the NCT07249073 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07249073 clinical trial?
NCT07249073 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 9 participants.