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Идёт набор NCT06196255

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

Фаза I / Фаза II С лечением Multiple Myeloma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: anti-FcRL5 CAR-T.
Кому может быть актуально
Состояния в реестре: Multiple Myeloma. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат 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.

Первичные конечные точки

  • Adverse events [Срок оценки: Baseline up to 28 days after CAR-T cells infusion]
Вторичные конечные точки (4)
  • overall response rate (ORR) [Срок оценки: Month 6, 12, 18 and 24]
  • complete response (CR) [Срок оценки: Month 6, 12, 18 and 24]
  • Overall survival (OS) [Срок оценки: Month 6, 12, 18 and 24]
  • Event-free survival (EFS) [Срок оценки: Month 6, 12, 18 and 24]

Критерии участия

Критерии включения

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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The affiliated hospital of Xuzhou Medical University — Xuzhou

Идентификаторы

NCT: NCT06196255 · XYFY2023-KL216-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗