Safety and Efficacy of Anti-BCMA/FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)

Phase 1

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: anti-BCMA/FcRL5 CAR T

• Registration Number: NCT06759181
• Lead Sponsor: Xuzhou Medical University

Brief Summary

This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-BCMA/FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-BCMAFcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA/FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Detailed Description

This open label, single-arm, Phase 2 study aims to evaluate the efficacy and safety of Anti-BCMA/FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA/FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable agent MTD and rp2d were confirmed. To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-29
• Study First Submitted QC: 2024-12-29
• Last Update Submitted: 2024-12-29
• Study Start: 2024-12-31
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2027-12-10
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anti BCMA/FcRL5 CAR-T	anti-BCMA/FcRL5 CAR T	anti-BCMA/FcRL5 autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10\^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy.

Primary Outcome Measures

Name	Time	Method
Adverse events	Baseline up to 28 days after CAR-T cells infusion	Adverse events assessed according to NCI-CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
overall response rate (ORR)	Month 6, 12, 18 and 24	Assessment of ORR at Month 6, 12, 18 and 24
complete response (CR)	Month 6, 12, 18 and 24	Assessment of CR at Month 6, 12, 18 and 24
Overall survival (OS)	Month 6, 12, 18 and 24	Assessment of OS at Month 6, 12, 18 and 24
Event-free survival (EFS)	Month 6, 12, 18 and 24	Assessment of EFS at Month 6, 12, 18 and 24

Trial Locations

Locations (1)

Xuzhou; 🇨🇳 Xuzhou, China