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Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Dec 2024 to Jun 2027
    • Study completion date: Mar 2025 to Dec 2028
    • Secondary endpoints: details revised at 1 of 2 entries
    • Publications: 2 to 3
    v10
  2. Re-verified, no change to tracked fieldsv9
  3. Secondary endpoints: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 5 words
    v8
  4. Primary completion date: Dec 2022 to Dec 2024
    • Start date: Apr 30, 2020 to Oct 21, 2021
    • Study completion date: Mar 2023 to Mar 2025
    v7
  5. Collaborators shortened, about 8 wordsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Lead sponsor: Guo ShiWei to Changhai Hospitalv5
  2. Start date changed from estimate of Mar 2020 to Apr 30, 2020v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2019 to Mar 2020
    • Site details revised
    v3
  4. Interventions: Anti-PD-1 monoclonal antibody (Drug), Cyclophosphamide (Drug), Fludarabine (Drug), Mutant KRAS G12V-specific TCR tranduced autologous T… to Anti-PD-1 monoclonal antibody (Drug), Cyclophosphamide (Drug), Fludarabine (Drug), Mutant KRAS G12V-specific TCR transduced autologous T…v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This clinical trial will evaluate the safety and activity of mutant KRAS G12V-specific TCR transduced T cell therapy for advanced pancreatic cancer patients who express the KRAS G12V mutation and HLA-A\*11:01 allele. The theoretical basis of this study is that mutant KRAS antigen-specific TCR transduced autologous Tcells will target and kill HLA-matched mutant KRAS cancer cells but not normal cells.
Trial Details
NCT Number NCT04146298
Lead Sponsor Changhai Hospital
Conditions
(from sponsor)		 Pancreatic Cancer, Pancreatic Neoplasms, Pancreatic Ductal Adenocarcinoma, Advanced Cancer
Related terms Pancreatic Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov