A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer

Официальное название

An Open-label, Single-arm, Multicenter, Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of CT041 Autologous CAR T Cell Injection After Adjuvant Chemotherapy in Subjects With Pancreatic Cancer

Обзор

An open-label, single-arm, multicenter, Phase Ib clinical trial to evaluate the efficacy and safety of CT041 Autologous CAR T Cell Injection after adjuvant chemotherapy in subjects with pancreatic cancer.

Подробное описание

This study is an open, multicenter, Phase Ib clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR T) in subjects with CLDN18.2 expression-positive pancreatic cancer who has undergone adjuvant chemotherapy. The aim of this study is to evaluate the efficacy, safety of CT041 treatment.

Вмешательства

• Препарат CT041 autologous CAR T-cell injection
  Treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion. Up to 3 times CT041 autologous CAR T-cell injection infusion

Первичные конечные точки

• Disease free survival (DFS) [Срок оценки: Up to 18 months]

Вторичные конечные точки (6)

• Incidence of Treatment Related adverse events (AEs), treatment related AEs, AEs of special interest (AESI). [Срок оценки: Up to 18 months]
• 1 year DFS rate [Срок оценки: Up to 18 months]
• Metastasis free Survival (MFS) [Срок оценки: Up to 18 months]
• Overall Survival (OS) [Срок оценки: Up to 18 months]
• The phamacokinetics in subjects receiving CT041 infusion in this study [Срок оценки: Up to 18 months]
• The immunogenicity in subjects receiving CT041 infusion in this study [Срок оценки: Up to 18 months]

Критерии участия

Критерии включения

• Voluntary participation in the clinical trial; fully understand, be informed about this study and have signed the ICF; willing to follow and able to complete all study procedures;
• Aged 18 to 79 years;
• Histologically confirmed pancreatic ductal adenocarcinoma;
• Macroscopic complete tumor removal (R0 or R1 resection);
• Postoperative pathological stage (pTNM): T1-3, N0-2, M0;
• Immunohistochemistry (IHC) staining of subject's tumor tissue sample is CLDN18.2-positive;
• Subjects had recovered from surgery and had received 3 months of standard adjuvant therapy;
• Abnormal CA19-9 level;
• With sufficient venous access for leukapheresis collection;
• ECOG performance status score 0-1;
• Adequate organ function;
• Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy;

Критерии исключения

• Prior neoadjuvant therapy for pancreatic cancer;
• Subjects with borderline resectable pancreatic cancer;
• Present or past history of metastatic or locally recurrent pancreatic cancer;
• Evidence of malignant ascites;
• Subjects had diseases that may interfere with CA19-9 level, including but not limited to cholangitis, pancreatitis, obstructive jaundice, etc.
• Toxicities caused by previous treatment have not recovered to CTCAE ≤ grade 2, except alopecia and other tolerable events as judged by the investigator or laboratory abnormalities allowed in this study;
• Pregnant or lactating women;
• Positive serology for HIV, Treponema pallidum or HCV;
• Any active infections, including but not limited to active tuberculosis, HBV, EBV, CMV, COVID-19 infections;
• Clinically significant thyroid dysfunction;
• Previous allergy to immunotherapy and related drugs, allergy to CT041 ingredients and other serious allergic history;
• Subjects who may be at high risk for potential digestive tract bleeding or perforation;
• Known active autoimmune disease, including but not limited to, psoriasis or rheumatoid arthritis, or other conditions requiring long-term immunosuppressive therapy;
• Subjects who have a history of organ transplantation or are awaiting organ transplantation;
• Subjects who require anticoagulant therapy;
• Subjects who are receiving or are expected to require long-term antiplatelet therapy during the study;
• Subjects who have experienced major surgery or have significant trauma within 4 weeks before apheresis, or who are expected to undergo major surgery during the study period;
• Previously received any gene-modified cell therapies (including CAR T, TCR T);
• Subjects who have other serious diseases that may restrict them from participating in the study assessed by investigators;
• Subjects with oxygen saturation ≤ 95%;
• Subjects who have signs of central nervous system diseases or clinically significant neurological examination abnormalities;
• Subjects who have other uncured malignant tumors in the past 3 years or at the same time, except those with very low degree of malignancy such as cervical cancer in situ and basal cell carcinoma of skin;
• Vaccination with live attenuated vaccines within 4 weeks prior to apheresis or planned during the study;
• Subjects who are unable to or unwilling to comply with the requirements of the study protocol as assessed by investigators.

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 · 8 центров

• Beijing Cancer Hospital — Пекин
• Henan Cancer Hospital — Чжэнчжоу
• Union Hospital, Tongji Medical College, Hua zhong University of Science and Technology — Ухань
• Hunan Provincial People's Hospital — Чанша
• Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine — Шанхай
• Fudan University Shanghai Cancer Hospital — Шанхай
• The First Affiliated Hospital of Xi'an Jiaotong University — Сиань
• Zhejiang Provincial People's Hospital — Ханчжоу

Идентификаторы

NCT: NCT05911217 · CT041-ST-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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