Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R/R NK and T-cell Malignancies

Официальное название

A Phase 1, Multicenter Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of GCC2005 With Lymphodepleting Chemotherapy in Treatment of Patients With Relapsed or Refractory NK and T-cell Malignancies

Обзор

This is a Phase 1 (a and b), first in human (FIH), single-arm, open-label, multicenter study to evaluate the safety, tolerability and efficacy of GCC2005 in the treatment of patients with relapsed/refractory (R/R) NK or T-cell malignancies who have received at least two prior lines of therapy.

Подробное описание

The purpose of the study is to assess the safety, tolerability, and preliminary efficacy of GCC2005 in treatment of patients with relapsed or refractory NK cell and T-cell malignancies expressing CD5. Phase 1a of the study will be conducted to establish a dose range that is well tolerated by the majority of participants and to determine a safety profile of GCC2005 in participant population. Phase 1b of this study is planned to evaluate safety, PK/PD characteristics, and preliminary efficacy following single administration, reflecting the cumulative exposure level obtained with multiple administration based on the safety and tolerability assessment results confirmed in Phase 1a, and to assess dose and regimen optimization to determine the RP2D for subsequent studies.

Вмешательства

• Препарат GCC2005
  CAR-NK Cell Therapy
• Препарат Cyclophosphamide
  Lymphodepleting chemotherapy
• Препарат Fludarabine
  Lymphodepleting chemotherapy

Первичные конечные точки

• Safety: Frequency, severity, and persistence of AEs and AEs Grade 3 or higher [Срок оценки: From the time of enrollment through End of Study (up to 18 months per patient)]
• To determine MTD and RP2D: Safety(based on frequency, severity, and persistence of AEs and AEs Grade 3 or higher), efficacy (based on ORR) and pharmacokinetics [Срок оценки: From the time of enrollment through End of Study (up to 18 months per patient)]

Критерии участия

Критерии включения

• Participants with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017).
• Participants with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any treatment option considered as assessed by the Investigator.
• According to the Lugano classification, Participants having lesion/nodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1.0 cm for extranodal lesions, and the boundaries are clearly shown.
• Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
• Participants who satisfy the criteria defined in the protocol.
• Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participants who comply with all procedures of this study and voluntarily give written consent

Критерии исключения

• Has T-ALL/T-LBL, CTCL or ALCL.
• Participants with CNS lymphoma or any involvement of the CNS.
• Participants who had a prior history of another malignancy over the last 3 years.
• Participants who have used hematopoietic growth factor therapy within 14 days prior to Screening.
• Participants who have had prior CAR-T or CAR-NK therapies.
• Presence of uncontrolled fungal, bacterial, viral infection or other infection requiring IV antimicrobials for management
• Participants with previous allogenic organ transplantation
• Participants with previous diagnosis of primary immunodeficiency or currently undergoing therapy of primary immunodeficiency.
• Participants with acute GvHD ≥ Grade 3 or extensive chronic GvHD within 2 weeks of lymphodepletion.
• Participants with known active Hepatitis B or C
• Participants with presence of Grade 2 or greater toxicity from the previous treatment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 3 центра

• Seoul National University Hosptial — Seoul
• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT06699771 · GCC2005A-P101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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