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

Trial ID: NCT05911217

Interventional - Phase 1 - Recruiting

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.

Conditions

• Pancreatic Cancer

Interventions

• CT041 autologous CAR T-cell injection

Eligibility

Inclusion criteria

• 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

• 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.

Sponsor

CARsgen Therapeutics Co., Ltd.

Source: Clinicaltrials.gov

Search more clinical trials on myTomorrows