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

NCT ID: NCT06196255

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-25
• Study Completion Date: 2028-01-01

Brief 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.

Detailed Description

This open label, single-arm, Phase 2 study aims 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. 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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anti FcRL5 CAR-T

anti-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.

Group Type: EXPERIMENTAL

anti-FcRL5 CAR-T

Intervention Type: DRUG

anti-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.

Interventions

anti-FcRL5 CAR-T

anti-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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kai Lin Xu，MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kailin Xu, MD.,PD.

Role: STUDY_CHAIR

The Affiliated Hospital oh Xuzhou Medical University

Locations

The affiliated hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kailin Xu, MD.,PD.

Role: CONTACT

lihmd@163.com

15162166166 ext. PD

Facility Contacts

Kailin Xu, MD

Role: primary

lihmd@163.com

15162166166

Other Identifiers

XYFY2023-KL216-01

Identifier Type: -

Identifier Source: org_study_id