Status:
UNKNOWN
TCR-T Cells in the Treatment of Advanced Pancreatic Cancer
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Shanghai Essight Bio Co.,Ltd
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
To investigate the safety, tolerability, efficacy and pharmacokinetics of TCR-T cells in the treatment of advanced pancreatic cancer
Detailed Description
The aim of this clinical trial is to investigate the safety, tolerability, efficacy and pharmacokinetics of TCR-T cell therapy in patients with advanced pancreatic cancer by intravenous injection, in ...
Eligibility Criteria
Inclusion
- To be eligible for the study, patients must meet all of the following criteria:
- Male or female, aged 18-75 years;
- Patients with advanced pancreatic cancer diagnosed by histology or cytology, patients who failed to respond to standard treatment, relapsed or voluntarily gave up;
- Patients must have tumor tissue that expresses specific tumor antigens, such as mutations in RAS and/or TP53;
- Patients must undergo HLA matching testing and meet the requirements of HLA matching.
- At least one measurable or evaluable lesion ≥15 mm according to RECIST1.1 criteria;
- Patients with ECOG \< 2 and life expectancy ≥3 months;
- 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;
- The patients met the requirements of apheresis without any contraindications.
- 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;
- 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;
- Sign an informed consent form.
Exclusion
- Patients who met any of the following criteria were not eligible for inclusion in the study:
- Persons with severe mental disorders;
- A positive virological test for any of the following: HIV; HCV; HBsAg; HBcAb was positive, and HBV DNA copy number and TPPA were positive.
- Patients with severe allergic history or allergic constitution;
- 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;
- 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;
- Combined with organ dysfunction, such as renal insufficiency;
- Had been enrolled in another clinical trial within 4 weeks before enrollment in the trial;
- Those who were unable to comply with the study protocol and follow-up plan due to physiological, family, social, geographical and other factors;
- Patients with contraindications to cyclophosphamide or fludarabine chemotherapy;
- Subjects who required additional immunosuppressive drug therapy within 72 hours before TCR-T infusion, except for the treatment of adverse events during the trial;
- Pregnant, lactating women, or men who plan to have children while participating in the study or within 100 days of receiving study treatment;
- Any other condition considered by the investigator to be ineligible for enrollment.
Key Trial Info
Start Date :
September 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 7 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06054984
Start Date
September 7 2021
End Date
September 7 2024
Last Update
October 13 2023
Active Locations (1)
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1
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025