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The primary aim of this study is to evaluate the efficacy of KRAS mutant antigen specific TCR-T cells in the treatment of patients with advanced pancreatic cancer.
The secondary aim is to evaluate the pharmacokinetic/pharmacodynamic characteristics of TCR-T cell therapy in patients with advanced pancreatic cancer and the survival of TCR-T cells.
The investigators will evaluate the changes of tumor microenvironment after treatment of advanced pancreatic cancer with KRAS mutant antigen specific TCR-T cells; Evaluating the correlation between cytokines and the occurrence of CRS and neurotoxicity
Full description
1.This study is a prospective and single arm clinical study. In this trial, 18 patients with advanced pancreatic cancer with KRAS G12V or G12D mutations and matching HLA-A*11:01 subtypes are recruited for autologous Tumor-T Cell Receptor (TCR) -Mediated T Cells therapy(TCR-T) therapy.Within 3 - 5 days after pretreatment, subjects will receive a single TCR-T infusion with an infusion dose of about 1 × 10⁹~1 × 10¹⁰.Once every 12 hours within 24 hours after TCR-T cell infusion, recombinant human interleukin-2 will be injected intravenously for 14 days .
After 3 months of treatment, the patient's condition was evaluated. If the subject did not occur tumor progression and did not occur adverse events (AEs) of level 3 or higher, a second TCR-T cell reinfusion can be performed (informed consent form needs to be signed again).
The study will evaluate the safety of TCR-T treatment by observing adverse events after cell therapy; evaluate the effectiveness of TCR-T compared to the results or historical data of the subject's own previous standard treatment regimen;and collect blood before and after cell infusion, measure the number and activity of TCR-T cells, and evaluate the pharmacokinetic (PK) characteristics of TCR-T.
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Inclusion and exclusion criteria
Inclusion Criteria:
1)Absolute neutrophil count≥1.5×10⁹/L;2)Platelet count≥50×10⁹/L;3)Hemoglobin≥90g/L;4)Bilirubin < 1.5 times upper limit of normal(Bile duct obstruction due to tumor compression were excluded);5)Serum creatinine ≤ 1.5 times the upper limit of normal range or creatinine clearance ≥ 60 mL/min.6)Serum alanine aminotransferase or aspartate aminotransferase is < 2.5 times the upper limit of the normal value (ULN) (if patients with liver metastasis, ≤5 times the ULN).7)Coagulation function normalised:INR≤1.5,PTT<1.2 times the upper limit of normal(Tumor - related anticoagulant therapy was excluded).
Exclusion Criteria:
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18 participants in 1 patient group
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Central trial contact
Zhifen Zeng, MD; Meng Zhang, MD
Data sourced from clinicaltrials.gov
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