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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CARsgen Therapeutics Co., Ltd.
• Collaborator: Fudan University

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.