Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma

Официальное название

A Phase 1/2 Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Preliminary Eficacy of Autologous SCG142 T Cell Receptor (TCR) T Cells in Patients With Advanced or Metastatic HPV16- or HPV52-positive Carcinomas

Обзор

This is a phase 1/2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy

Подробное описание

This study will be conducted in 2 parts:

The Phase 1 part of the trial consists of a dose-escalation portion designed to evaluate the safety and tolerability of SCG142, and to identify the RP2D.

The Phase 2 part of the trial is designed to evaluate the preliminary efficacy of SCG142 in the same patient populations.

Вмешательства

• Биопрепарат SCG142
  Autologous SCG142 cells infused on Day 0 after completion of lymphedepletion chemotherapy
• Препарат Cyclophosphamide
  for 3 consecutive days
• Препарат Fludarabine
  for 3 consecutive days

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events (Phase 1) [Срок оценки: 2 years]
• Objective response rate (ORR) (Phase 2) [Срок оценки: 2 years]

Вторичные конечные точки (6)

• Objective response rate (ORR) (Phase 1) [Срок оценки: 2 year]
• Duration of objective response (DOR) (Phase 1&2) [Срок оценки: 2 year]
• Disease control rate (DCR) (Phase 1&2) [Срок оценки: 2 year]
• Progression-free survival (PFS) (Phase 1&2) [Срок оценки: 2 year]
• Overall survival (OS) (Phase 1&2) [Срок оценки: 2 year]
• Incidence of Treatment-Emergent Adverse Events (Phase 2) [Срок оценки: 2 years]

Критерии участия

Main Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma (SCC); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.
• Tumor tissue positive for HPV16 or HPV52.
• Advanced or metastatic carcinoma with progression after at least 1 line of standard of care systemic therapies, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy.
• Human leukocyte antigen (HLA)-A\*02:01 genotype.
• Measurable disease as defined by RECIST v1.1.
• Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
• Anticipated life expectancy ≥3 months.
• Adequate laboratory parameters including hematologic, renal, hepatic and coagulation function.

Main Exclusion Criteria:

• Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement.
• Active brain metastasis or leptomeningeal metastases.
• History of other malignancy within 2 years prior to Screening.
• History of organ transplant.
• Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• History of active cardiac disease.
• History of active pulmonary disease.
• Active, known, or suspected autoimmune disease.
• Lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of SCG142.
• Prior exposure to any cell therapy including, but not limited to natural killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DCs), cytotoxic T lymphocytes (CTLs), stem cell therapy, and CAR/TCR-T cell therapy.
• Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and/or any component of SCG142.
• Any serious medical condition or abnormality in clinical laboratory tests.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06505551 · SCG142-UR-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗