NCT06581640 Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
| NCT ID | NCT06581640 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2024-09-24 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 5 participants in total. It began in 2024-09-24 with a primary completion date of 2028-12-31.
⚠ 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
To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed/refractory multiple myeloma
Eligibility Criteria
Inclusion Criteria: 1. Age 18-80 years, no gender restrictions; 2. Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies; 3. Flow cytometry or histology confirms positive BCMA expression in myeloma cells; 4. As judged by the investigator, the expected survival time is \>3 months; 5. ECOG performance status score ≤2, KPS \>60%; 6. The patient has good liver, kidney, heart, and lung function: ALT and AST ≤2.5×ULN, those with liver involvement can be relaxed to ≤5×ULN; serum total bilirubin \<34 μmol/L; creatinine clearance rate \>30 mL/min; heart ejection fraction (EF) ≥40%, no pericardial effusion and significant arrhythmia; indoor SpO2 ≥92%; 7. Peripheral blood lymphocyte absolute count ALC ≥0.5 ×10\^9/L, PLT \>30×10\^9/L, Hb \>80 g/L and has a single collection venous access, and there are no other contraindications for hematopoietic cell separation; 8. Those with fertility must agree to use highly effective contraceptive methods; 9. The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily. Exclusion Criteria: 1. Pregnant or nursing women, as well as women planning to become pregnant within the next six months; 2. Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus; 3. History of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of disease activity); 4. Previously received treatment targeting BCMA; 5. Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks; 6. Presence of uncontrolled active bacterial or fungal infection; 7. Allergic to research-related drugs or cell components; 8. Presence of active autoimmune diseases; 9. Currently have unstable or active ulcers or gastrointestinal bleeding; 10. Unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders; 11. Received other experimental drug treatments within the last 3 months; 12. The researcher believes that for other reasons, the individual is not suitable for the clinical trial.
Contact & Investigator
Bing Xu
PRINCIPAL INVESTIGATOR
The First Aiffiliated hosptical of xiamen University
Frequently Asked Questions
Who can join the NCT06581640 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 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 NCT06581640 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06581640 currently recruiting?
Yes, NCT06581640 is actively recruiting participants. Contact the research team at xubingzhangjian@126.com for enrollment information.
Where is the NCT06581640 trial being conducted?
This trial is being conducted at Xiamen, China.
Who is sponsoring the NCT06581640 clinical trial?
NCT06581640 is sponsored by The First Affiliated Hospital of Xiamen University. The principal investigator is Bing Xu at The First Aiffiliated hosptical of xiamen University. The trial plans to enroll 5 participants.