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Идёт набор NCT06271252

A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study

Фаза I С лечением Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders

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: OriCAR-017.
Кому может быть актуально
Состояния в реестре: Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Neoplasms, Hemostatic Disorders. Базовые параметры: 18 лет — 75 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
США
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

A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Anti-GPRC5D CAR-T Cell Product (OriCAR-017) in Subjects With Relapsed/Refractory Multiple Myeloma.

Обзор

The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma. RIGEL Study

Подробное описание

This is a Phase I/II, open-label multicenter study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of anti-GPRC5D CAR-T cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma". The study will consist of a Phase I dose escalation stage involving three doses as a single IV infusion) with up to 18 evaluable subjects and a dose expansion stage with 10-15 evaluable subjects, followed by a Phase II stage with up to 48 evaluable subjects.

Вмешательства

  • Препарат OriCAR-017
    Anti-GPRC5D CAR-T cell product

Первичные конечные точки

  • Maximum tolerated dose (MTD) of OriCAR-017 US-P1 [Срок оценки: Up to 28 days]
  • Dose-limiting toxicity (DLT) [Срок оценки: Up to 28 days]
Вторичные конечные точки (9)
  • Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM [Срок оценки: Up to 2 years]
  • Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM [Срок оценки: Up to 2 years]
  • Assessment of Duration of Response (DOR) of treatment in patients with RR/MM [Срок оценки: Up to 2 years]
  • Progress-Free Survival (PFS) of treatment in patients with RR/MM [Срок оценки: Up to 2 years]
  • Assessment of Overall Survival (OS) of treatment in patients with RR/MM [Срок оценки: Up to 2 years]
  • Assessment of MRD negative Rate [Срок оценки: Up to 2 years]
  • Assessment of Overall Response Rate (ORR) [Срок оценки: Up to 2 years]
  • Assessment of Disease Control Rate (DCR) [Срок оценки: Up to 2 years]
  • Assessment of Clinical Benefit Rate (CBR) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

Capable of giving signed informed consent

Subjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).

Expected survival period is >12 weeks.

Diagnosis of MM according to the IMWG criteria (2016 version).

One of the following criteria must be met:

If immunoglobulin (Ig)G type MM, then serum M protein >10 g/L; if IgA, IgD, IgE or IgM type MM, then serum M protein >5 g/L

Urine M protein level >200 mg/24 hour

If light chain type MM, then serum free light chain (sFLC) >100 mg/L and K/λ FLC ratio is abnormal.

Extramedullary lesions (>1 cm for diameter of the short axis).

For Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy.

For Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM)

Subjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function.

Subject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion.

Критерии исключения

Pregnant or breastfeeding.

Seropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection

Known active or prior history of CNS involvement

History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs or required systemic application of immunosuppressive or other drugs in the past 2 years

Presence of uncontrolled active infection

Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.

Subjects who received allogeneic stem cell therapy.

Any condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.

Received Bendamustine treatment 1 year prior to Screening Visit.

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

США · 1 центр
  • Northside Hospital — Atlanta

Идентификаторы

NCT: NCT06271252 · OriCAR-017-US-P1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗