Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Aug 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with relapsed or refractory multiple myeloma, a type of blood cancer. The focus is on using modified T cells, which are a type of immune cell, to target a specific protein called BCMA found on myeloma cells. The goal is to see if this treatment is safe and how well it works for patients whose cancer has not improved with other therapies.

To be eligible for this trial, participants need to be between 18 and 80 years old and have a confirmed diagnosis of relapsed or refractory multiple myeloma. They should also have good overall health, particularly with their liver, kidneys, and heart. Participants can expect to receive the new treatment and be monitored closely for any side effects. It's important to note that this trial is currently recruiting patients, and participants will need to provide informed consent, meaning they understand the study and agree to take part.

Gender

ALL

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.