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NeoTIL in Advanced Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv7
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  3. Minor Site contact updatedv5
  4. Minor Interventions: Cyclophosphamide (Drug), Fludarabine (Drug), Interleukin-2 (Drug), NeoTIL (Other), Radiotherapy (Other) to Cyclophosphamide (Drug), Fludarabine (Drug), Interleukin-2 (Drug), NeoTIL (Biological), Radiotherapy (Radiation)
    • Study description revised
    v4
  5. Minor Study site revisedv3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2020 to Mar 9, 2021
    • Site details revised
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Single center, single arm pilot trial to test the feasibility, safety and efficacy of NeoTIL-ACT combined with low-dose irradiation (LDI) in patients with advanced, recurrent or metastatic solid tumors. The trial is based on lymphodepleting chemotherapy followed by LDI, and then ACT utilizing ex vivo expanded TIL, enriched for tumor antigen specificity (NeoTIL), in combination with high dose Interleukin-2 (IL-2) (optional, depending on patient's tolerance). LDI will be administered once to metastatic lesions using tomotherapy.
Trial Details
NCT Number NCT04643574
Lead Sponsor Centre Hospitalier Universitaire Vaudois
Conditions
(from sponsor)
Solid Tumor, Adult
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov