NCT05911217招募中1 期
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
CARsgen Therapeutics Co., Ltd.8 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年7月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
anti-claudin18.2 chimeric antigen receptor T-cell therapy
Experimental
Experimental: anti-claudin18.2 chimeric antigen receptor T-cell therapy Phase 1b: Evaluate the efficacy and safety of CT041
干预措施: CT041 autologous CAR T-cell injection (Drug)
结局指标
主要结局
Disease free survival (DFS)
时间窗: Up to 18 months
The time from the first infusion to the occurrence of local recurrence/distant metastasis or death from any cause, whichever occurred first.
次要结局
- Incidence of Treatment Related adverse events (AEs), treatment related AEs, AEs of special interest (AESI).(Up to 18 months)
- 1 year DFS rate(Up to 18 months)
- Overall Survival (OS)(Up to 18 months)
- The phamacokinetics in subjects receiving CT041 infusion in this study(Up to 18 months)
- Metastasis free Survival (MFS)(Up to 18 months)
- The immunogenicity in subjects receiving CT041 infusion in this study(Up to 18 months)
研究者
研究点 (8)
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相关资讯
CARsgen's Satri-cel Shows Durable Survival Benefit in Advanced Gastric Cancer with 4.5-Year Follow-up- CARsgen's satri-cel CAR T-cell therapy achieved 100% objective response rate in patients with advanced gastric cancer when used sequentially after first-line treatment, with median follow-up exceeding 4.5 years.
- The therapy demonstrated median progression-free survival of 20.9 months from initial first-line therapy, with two patients undergoing successful surgical resection after treatment.
- Safety profile remained favorable with no grade 3 or higher cytokine release syndrome, no neurotoxicity, and no treatment-related deaths reported.
- The long-term data supports satri-cel's potential as a first-in-class Claudin18.2-targeted CAR T-cell therapy, with regulatory applications already submitted in China.3 months agoCARsgen's Satri-cel Shows Promising Results in World's First CAR T-Cell Adjuvant Therapy Trial for Pancreatic Cancer- CARsgen presented preliminary results from the world's first proof-of-concept study exploring CAR T-cell therapy for adjuvant treatment of solid tumors at ESMO Congress 2025.
- The Phase Ib trial of satri-cel in high-risk pancreatic cancer patients achieved an 83.3% nine-month disease-free survival rate with significant CA19-9 biomarker reductions.
- Only one of six patients experienced disease recurrence during a median follow-up of 6.05 months, with manageable safety profile including Grade 1-2 cytokine release syndrome.
- The study enrolled patients with Claudin18.2-positive pancreatic ductal adenocarcinoma who had undergone curative resection but showed abnormal CA19-9 levels after standard chemotherapy.11 months agoCARsgen's Satri-cel Shows Promise in Phase II Trial for Advanced Gastric and GEJ Cancers- CARsgen Therapeutics' satri-cel significantly improved progression-free survival in patients with advanced gastric/gastroesophageal junction cancers.
- The Phase II trial (CT041-ST-01) evaluated satri-cel in patients with Claudin18.2-positive tumors who had failed at least two prior lines of therapy.
- CARsgen plans to submit a New Drug Application to China's NMPA in the first half of 2025, potentially marking the first CAR-T therapy for solid tumors.
- Satri-cel has received Breakthrough Therapy Designation from China's NMPA and RMAT designation from the U.S. FDA, expediting its development and review.last year