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

NCT06196255 | Recruiting Phase 1

• 1 other identifier: XYFY2023-KL216-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; FcRL5

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Adverse events assessed according to NCI-CTCAE v5.0

  Baseline up to 28 days after CAR-T cells infusion

Secondary Outcomes (4)

• overall response rate (ORR)

  Month 6, 12, 18 and 24

• complete response (CR)

  Month 6, 12, 18 and 24

• Overall survival (OS)

  Month 6, 12, 18 and 24

• Event-free survival (EFS)

  Month 6, 12, 18 and 24

Study Arms (1)

anti FcRL5 CAR-T

EXPERIMENTAL

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.

Drug: anti-FcRL5 CAR-T

Interventions

anti-FcRL5 CAR-T 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.

anti FcRL5 CAR-T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

The affiliated hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kailin Xu, MD.,PD.

  The Affiliated Hospital oh Xuzhou Medical University

  STUDY CHAIR

Central Study Contacts

Kailin Xu, MD.,PD.

CONTACT

15162166166; lihmd@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: December 25, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)