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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2028
  • participants needed
    20
  • sponsor
    Xuzhou Medical University
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Updated on 15 January 2024
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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.

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.

Details
Condition Multiple Myeloma
Age 18years - 70years
Treatment anti-FcRL5 CAR-T
Clinical Study IdentifierNCT06196255
SponsorXuzhou Medical University
Last Modified on15 January 2024

Eligibility

 Yes No Not Sure

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
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
Clear my responses
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