alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells

Официальное название

An Open-label, Phase I Study to Assess the Safety of Multiple Doses of CYAD-101, Administered After Standard FOLFOX or FOLFIRI Chemotherapy in Patients With Unresectable Metastatic Colorectal Cancer

Обзор

The purpose of the alloSHRINK study is to assess the safety, cell kinetics and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered after standard chemotherapy

Подробное описание

This Study aims to determine and confirm the recommended dose of the allogeneic CYAD-101 cells after standard FOLFOX or FOLFIRI chemotherapy in patients with unresectable metastatic colorectal cancer

Вмешательства

• Препарат CYAD-101
  Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
• Препарат FOLFOX
  5-FU, leucovorin and oxaliplatin
• Препарат FOLFIRI
  5-FU, leucovorin and irinotecan

Первичные конечные точки

• Occurence of Dose Limiting Toxicities [Срок оценки: Up to 82 days post first CYAD-101 Infusion]

Критерии участия

Критерии включения

• Histologically proven metastatic adenocarcinoma of the colon or rectum.

• Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
• Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.
• Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
• FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
• FOLFIRI segment: Documented progressive disease (PD) under FOLFIRI treatment, with or without targeted therapy, given within 3 months prior to study registration. Anti-cancer therapy post FOLFIRI-documented PD prior to study registration is authorized if discontinued at least 7 days before the planned study registration. Radiotherapy is not authorized.
• The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.

Критерии исключения

• The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).
• Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.
• Filgrastim (Granulocyte-Colony-Stimulating Factor \[G-CSF\]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration.
• Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 3 центра

• Institut Jules Bordet — Brussels
• UZ Antwerpen — Edegem
• UZ Leuven — Leuven

США · 1 центр

• Moffit Cancer Center — Tampa

Публикации

• Michaux A, Mauen S, Breman E, Dheur MS, Twyffels L, Saerens L, Jacques-Hespel C, Gauthy E, Agaugue S, Gilham DE, Sotiropoulou PA. Clinical Grade Manufacture of CYAD-101, a NKG2D-based, First in Class, Non-Gene-edited Allogeneic CAR T-Cell Therapy. J Immunother. 2022 Apr 1;45(3):150-161. doi: 10.1097/CJI.0000000000000413. PMID 35191428

Идентификаторы

NCT: NCT03692429 · CYAD-N2L-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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