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KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Sep 1, 2026 → Sep 1, 2028
See other at-risk trials from Christian Hinrichs

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Sep 1, 2026 to Sep 1, 2028
    • Study completion pushed from Dec 31, 2028 to Dec 31, 2030
    v9
  2. Minor Eligibility criteria expanded, about 144 words
    • Study sites revised (2)
    v8
  3. Minor Re-verified, no change to tracked fieldsv7
  4. Notable Primary completion date: Sep 1, 2025 to Sep 1, 2026v6 Show 5 more changesShow less
    • Enrollment target: 42 to 30
    • Study sites: 1 to 2
    • Interventions: Aldesleukin 720,000 IU/kg IV every eight hours (Drug), KK-LC-1 TCR-T cells (Drug) to Aldesleukin (Drug), KK-LC-1 TCR-T cells (Biological)
    • Eligibility criteria expanded, about 385 words
    • Collaborators revised (2)
  5. Notable Primary completion date: Sep 1, 2023 to Sep 1, 2025v5
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  1. Minor Collaborators: 3 to 2v4
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2022 to Sep 26, 2022
    • Site details revised
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
5,418 trials monitored
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4,790 trials monitored
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1,278 trials monitored
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and 1 more disease
This is a phase I clinical trial to determine the maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells for the treatment of metastatic cancers that express KK-LC-1. Participants will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin. The safety profile and clinical response to treatment will be determined.
Trial Details
NCT Number NCT05483491
Lead Sponsor Christian Hinrichs
Collaborators: National Cancer Institute (NCI), Iovance Biotherapeutics, Inc.
Conditions
(from sponsor)
Gastric Cancer, Breast Cancer, Cervical Cancer, Lung Cancer
Related terms Breast Neoplasms, Lung Neoplasms, Stomach Neoplasms, Uterine Cervical Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov