Evaluating CT041 CAR T-cell therapy after chemotherapy for pancreatic cancer

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

This study is testing a new CAR T-cell therapy called CT041 to see if it can help people with pancreatic cancer feel better after they've had chemotherapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: CARsgen Therapeutics Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR T, immunotherapy, chemotherapy, chimeric antigen receptor
• Locations: 8 sites (Beijing, Beijing Municipality and 7 other locations)
• Trial ID: NCT05911217 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm, multicenter Phase Ib clinical trial aims to assess the efficacy and safety of CT041, an autologous CAR T-cell therapy targeting Claudin18.2, in patients with pancreatic cancer who have undergone adjuvant chemotherapy. Participants must have histologically confirmed pancreatic ductal adenocarcinoma and express CLDN18.2 in their tumor tissue. The study will involve administering CT041 after the standard chemotherapy regimen and monitoring the outcomes for efficacy and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 79 with resected pancreatic ductal adenocarcinoma that expresses CLDN18.2 and who have completed adjuvant chemotherapy.

Not a fit: Patients who have received prior neoadjuvant therapy or have borderline resectable pancreatic cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option that enhances the effectiveness of existing chemotherapy for pancreatic cancer patients.

How similar studies have performed: While CAR T-cell therapies have shown promise in other cancers, this specific approach targeting CLDN18.2 in pancreatic cancer is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. 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;
2. Aged 18 to 79 years;
3. Histologically confirmed pancreatic ductal adenocarcinoma;
4. Macroscopic complete tumor removal (R0 or R1 resection);
5. Postoperative pathological stage (pTNM): T1-3, N0-2, M0;
6. Immunohistochemistry (IHC) staining of subject's tumor tissue sample is CLDN18.2-positive;
7. Subjects had recovered from surgery and had received 3 months of standard adjuvant therapy;
8. Abnormal CA19-9 level;
9. With sufficient venous access for leukapheresis collection;
10. ECOG performance status score 0-1;
11. Adequate organ function;
12. Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy;

Exclusion Criteria:

1. Prior neoadjuvant therapy for pancreatic cancer;
2. Subjects with borderline resectable pancreatic cancer;
3. Present or past history of metastatic or locally recurrent pancreatic cancer;
4. Evidence of malignant ascites;
5. Subjects had diseases that may interfere with CA19-9 level, including but not limited to cholangitis, pancreatitis, obstructive jaundice, etc.
6. 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;
7. Pregnant or lactating women;
8. Positive serology for HIV, Treponema pallidum or HCV;
9. Any active infections, including but not limited to active tuberculosis, HBV, EBV, CMV, COVID-19 infections;
10. Clinically significant thyroid dysfunction;
11. Previous allergy to immunotherapy and related drugs, allergy to CT041 ingredients and other serious allergic history;
12. Subjects who may be at high risk for potential digestive tract bleeding or perforation;
13. Known active autoimmune disease, including but not limited to, psoriasis or rheumatoid arthritis, or other conditions requiring long-term immunosuppressive therapy;
14. Subjects who have a history of organ transplantation or are awaiting organ transplantation;
15. Subjects who require anticoagulant therapy;
16. Subjects who are receiving or are expected to require long-term antiplatelet therapy during the study;
17. 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;
18. Previously received any gene-modified cell therapies (including CAR T, TCR T);
19. Subjects who have other serious diseases that may restrict them from participating in the study assessed by investigators;
20. Subjects with oxygen saturation ≤ 95%;
21. Subjects who have signs of central nervous system diseases or clinically significant neurological examination abnormalities;
22. 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;
23. Vaccination with live attenuated vaccines within 4 weeks prior to apheresis or planned during the study;
24. Subjects who are unable to or unwilling to comply with the requirements of the study protocol as assessed by investigators.

Where this trial is running

Beijing, Beijing Municipality and 7 other locations

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Union Hospital, Tongji Medical College, Hua zhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Hunan Provincial People's Hospital — Changsha, Hunan, China (Recruiting)
• Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• Fudan University Shanghai Cancer Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xian, Shanxi, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Xianjun Yu, Ph.D — Fudan University
• Study coordinator: Lifeng Zhang

Conditions Pancreatic Cancer; Adjuvant therapy; Claudin18.2; CLDN18.2; CAR T cell