RecruitingPhase 2NCT06581640
Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
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
Sponsor
The First Affiliated Hospital of Xiamen University
Enrollment
5 participants
Start Date
Sep 24, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria9
- 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 Criteria12
- 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;
- 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;
- Received other experimental drug treatments within the last 3 months;
- The researcher believes that for other reasons, the individual is not suitable for the clinical trial.
Interventions
BIOLOGICALCAR-T treatment
Peripheral blood lymphocyte collection, PBMC separation, BCMA CAR-T cell preparation/storage, lymphodepletion chemotherapy pretreatment for the subject, and BCMA CAR-T cell infusion.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06581640
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