CLINICAL_TRIALS ClinicalTrials.gov record update

A Prospective, One Arm Clinical Study on the Safety, Efficacy and Pharmacokinetics of KRAS Mutant Antigen Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT05438667
Title field or adapter rule: {'original_value': 'A Prospective, One Arm Clinical Study on the Safety, Efficacy and Pharmacokinetics of KRAS Mutant Antigen Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:26.803708+00:00
Published At: 2026-09-01T00:00:00+00:00
Record Updated At: 2026-09-01
Source Retrieved At: 2026-10-31T22:17:58.991924+00:00
Timestamp Basis: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

protocolSection.conditionsModule.conditions: ["Pancreatic Cancer"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-09-01", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT05438667"
protocolSection.identificationModule.officialTitle: "A Prospective, One Arm Clinical Study on the Safety, Efficacy and Pharmacokinetics of KRAS Mutant Antigen Specific TCR-T Cells in the Treatment of Advanced Solid Tumors."
protocolSection.statusModule.overallStatus: "TERMINATED"
protocolSection.designModule.phases: ["EARLY_PHASE1"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

{'armGroupLabels': ['TCR-T treatment group'], 'description': '1.Preprocessing strategy：\n\n1. Cyclophosphamide: 300-450mg/m², dissolved in 100ml 0.9% sodium chloride saline, intravenous drip for 60minutes, and 0.4g Mesna injected at 0hour, 4hours and 8 hours after cyclophosphamide,4days and 5 days before TCR-T cell infusion.\n2. Fludarabine: 30mg/m² , dissolved in 100ml 0.9% sodium chloride saline, intravenous drip for 30minutes before 3 to 5days before TCR-T cell infusion.\n\n2.Within 3-5 days after pretreatment, subjects will receive a single TCR-T reinfusion with an infusion dose of about 1 × 10⁹～1 × 10¹⁰.\n\n3.Once every 12 hours within 24 hours after TCR-T cell infusion, recombinant human interleukin-2 (injection unit: 500000 units /m², once every 12 hours, subcutaneous injection) will be injected intravenously for 5 days (10 times in total).\n\n4.After 3 months of treatment, 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.', 'name': 'TCR-T therapy', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])

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