Treatment for relapsed and refractory multiple myeloma using CAR-T cell therapy

Efficacy and Safety Study of Anti-BCMA/FcRL5 CAR-T Cells in Subjects With Relapsed and Refractory Multiple Myeloma

This study is testing a new CAR-T cell therapy for people with relapsed and hard-to-treat multiple myeloma to see if it is safe and effective.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Xuzhou Medical University (other)
• Drugs / interventions: immunotherapy, CAR-T, chimeric antigen receptor, cyclophosphamide, fludarabine
• Locations: 1 site (Xuzhou)
• Trial ID: NCT06759181 on ClinicalTrials.gov

What this trial studies

This open label, single-arm Phase 2 study evaluates the safety and efficacy of Anti-BCMA/FcRL5 CAR-T cell therapy in patients with relapsed and refractory multiple myeloma. Participants will undergo a leukapheresis procedure to manufacture CAR-modified T cells, followed by lymphodepleting therapy with fludarabine and cyclophosphamide before receiving the CAR-T cell infusion. The study aims to observe dose-limiting toxicity and determine the maximum tolerated dose to inform future clinical trials.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with relapsed or refractory multiple myeloma who are not suitable for stem cell transplantation.

Not a fit: Patients who are pregnant, breastfeeding, or have active infectious diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results in treating multiple myeloma, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

Age is 18\~70 years old; Expected survival period of\>12 weeks; Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging; Patients with refractory multiple myeloma; Patients with multiple myeloma recurrence; ALT and AST \<3 times normal; bilirubin \<2.0mg / dl; Quality of survival score (KPS)\> 50%; The patient has no serious heart, liver, kidney and other diseases; Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy; Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions; Blood can be obtained intravenously, without other contraindications to leukapheresis; Understand and voluntarily sign a written informed consent form.

Exclusion Criteria:

Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months; Infectious diseases (such as HIV, active tuberculosis, etc.); Active hepatitis B or hepatitis C infection; Feasibility assessment screening demonstrated \<10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 costimulation (\<5-fold); Abnormal vital signs, and unable to cooperate with the examination; Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation; Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2; Subjects with a systemic infection or a severe local infection requiring anti-infective treatment; Subjects with severe autoimmune disease; The doctor believes there were other reasons for inclusion

Where this trial is running

Xuzhou

• Xuzhou — Xuzhou, China (RECRUITING)

Study contacts

• Study coordinator: Kailin Xu, PhD

Conditions: Multiple Myeloma, multiple myeloma, BCMA, FcRL5