NCT06581640
Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
Recruiting · Phase 2 · The First Affiliated Hospital of Xiamen University · registry updated 2024-09-25
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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%;
Exclusion
- Pregnant or nursing women, as well as women planning to become pregnant within the next six 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);
- Previously received treatment targeting BCMA;
- Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks;
- Presence of uncontrolled active bacterial or fungal infection;