Tests BCMA-targeting CAR-T cells in relapsed or refractory multiple myeloma
Tests BCMA-targeting CAR-T cell treatment for safety in adults with relapsed or refractory multiple myeloma.
Plain-language title generated from the registry record
Registry title: Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
Key facts
- Where
- Xiamen, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06581640, who can take part
Where in China
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Xiamen University
- Trial code
- NCT06581640
- Record updated
- 25 September 2024
- Original description
To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed/refractory multiple myelomaRead full original descriptionShow less
A Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor-modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed/refractory multiple myeloma
Inclusion: Age 18-80 years, no gender restrictions; Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies; Flow cytometry or histology confirms positive BCMA expression in myeloma cells; As judged by the investigator, the expected survival time is >3 months; ECOG performance status score ≤2, KPS >60%; 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%; 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; Those with fertility must agree to use highly effective contraceptive methods; The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily.
Exclusion: Previously received treatment targeting BCMA; Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks; Received other experimental drug treatments within the last 3 months; Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus; 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); Presence of uncontrolled active bacterial or fungal infection; Allergic to research-related drugs or cell components; Presence of active autoimmune diseases; Currently have unstable or active ulcers or gastrointestinal bleeding; Unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders; Pregnant or nursing women, as well as women planning to become pregnant within the next six months; The researcher believes that for other reasons, the individual is not suitable for the clinical trial.