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Recruiting NCT06196255

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

Phase I / Phase II Interventional Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: anti-FcRL5 CAR-T.
Who it may be relevant to
Registry conditions: Multiple Myeloma. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety Study of Anti-FcRL5 CAR-T Cells in Subjects With Relapsed and Refractory Multiple Myeloma

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • Adverse events [Time frame: Baseline up to 28 days after CAR-T cells infusion]
Secondary outcome measures (4)
  • overall response rate (ORR) [Time frame: Month 6, 12, 18 and 24]
  • complete response (CR) [Time frame: Month 6, 12, 18 and 24]
  • Overall survival (OS) [Time frame: Month 6, 12, 18 and 24]
  • Event-free survival (EFS) [Time frame: Month 6, 12, 18 and 24]

Eligibility 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:

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The affiliated hospital of Xuzhou Medical University — Xuzhou

Identifiers

NCT: NCT06196255 · XYFY2023-KL216-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗