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

• Status: Recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-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-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xuzhou Medical University

Criteria

Inclusion Criteria:

The set subject inclusion criteria include multiple documents of multiple myeloma, no effective treatment options (e. g. autologous or allogeneic stem cell transplantation) and limited outcome (<2 years) with existing therapies, as follows:

1. Age is 18~70 years old;

2. Expected survival period of>12 weeks;

3. Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging;

4. Patients with refractory multiple myeloma;

5. Patients with multiple myeloma recurrence;

6. ALT and AST <3 times normal; bilirubin <2.0mg / dl;

7. Quality of survival score (KPS)> 50%;

8. The patient has no serious heart, liver, kidney and other diseases;

9. Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy;

10. Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions;

11. Blood can be obtained intravenously, without other contraindications to leukapheresis;

12. Understand and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;

2. Infectious diseases (such as HIV, active tuberculosis, etc.);

3. Active hepatitis B or hepatitis C infection;

4. Feasibility assessment screening demonstrated <10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 costimulation (<5-fold);

5. Abnormal vital signs, and unable to cooperate with the examination;

6. Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation;

7. Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2;

8. Subjects with a systemic infection or a severe local infection requiring anti-infective treatment;

9. Subjects with severe autoimmune disease;

10. The doctor believes there were other reasons for inclusion