TCR-T Cells in the Treatment of Advanced Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2024-09-07
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the safety, tolerability, efficacy and pharmacokinetics of TCR-T cells in the treatment of advanced pancreatic cancer

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

Details

• Lead Sponsor: Ruijin Hospital
• Collaborator: Shanghai Essight Bio Co.,Ltd

Criteria

Inclusion Criteria:

• To be eligible for the study, patients must meet all of the following criteria:

1. Male or female, aged 18-75 years;

2. Patients with advanced pancreatic cancer diagnosed by histology or cytology, patients who failed to respond to standard treatment, relapsed or voluntarily gave up;

3. Patients must have tumor tissue that expresses specific tumor antigens, such as mutations in RAS and/or TP53;

4. Patients must undergo HLA matching testing and meet the requirements of HLA matching.

5. At least one measurable or evaluable lesion ≥15 mm according to RECIST1.1 criteria;

6. Patients with ECOG < 2 and life expectancy ≥3 months;

7. a) Liver function: ALT/AST < 3 times the upper limit of normal value (ULN) and bilirubin ≤34.2μmol/L; b) renal function: creatinine < 220μmol/L; c) terminal oxygen saturation ≥95% in room air; d) Cardiac function: left ventricular ejection fraction (LVEF) ≥60%; e) Blood routine: absolute neutrophil count ≥ 1×109/L; Platelet count ≥70×109/L; Absolute lymphocyte count ≥100 cells /μL;

8. The patients met the requirements of apheresis without any contraindications.

9. Women of childbearing age who have a negative urine pregnancy test at screening and before starting dosing and who have agreed to use highly effective contraception for at least 100 days after infusion; Female participants must agree not to donate eggs (oocytes, oocytes) for assisted reproductive purposes during the study and for 90 days after receiving the last study drug;

10. Male subjects with a fertile partner must consent to use an effective barrier method of contraception for at least 100 days after infusion; Must agree not to donate sperm for at least one year;

11. Sign an informed consent form.

Exclusion Criteria:

• Patients who met any of the following criteria were not eligible for inclusion in the study:

1. Persons with severe mental disorders;

2. A positive virological test for any of the following: HIV; HCV; HBsAg; HBcAb was positive, and HBV DNA copy number and TPPA were positive.

3. Patients with severe allergic history or allergic constitution;

4. Severe underlying medical conditions such as evidence of other serious active viral, bacterial or uncontrolled systemic fungal infection; Active autoimmune disease or a history of autoimmune disease within 3 years;

5. A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years;

6. Combined with organ dysfunction, such as renal insufficiency;

7. Had been enrolled in another clinical trial within 4 weeks before enrollment in the trial;

8. Those who were unable to comply with the study protocol and follow-up plan due to physiological, family, social, geographical and other factors;

9. Patients with contraindications to cyclophosphamide or fludarabine chemotherapy;

10. Subjects who required additional immunosuppressive drug therapy within 72 hours before TCR-T infusion, except for the treatment of adverse events during the trial;

11. Pregnant, lactating women, or men who plan to have children while participating in the study or within 100 days of receiving study treatment;

12. Any other condition considered by the investigator to be ineligible for enrollment.