Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This is a prospective, multicenter, phase I/II, open-label, two-stage design of PD1+ TILs infusion in metastatic or advanced TNBC. TILS001 includes 3 parts. Previous to each phase inclusion, a specific ICF must be signed by the patient. Participants potentially eligible to participate in the clinical trial will be offered to sign a ICF three times prior to TILs treatment: 1) to allow for collection of archival FFPE tissue samples for determination PD1 by mRNA (Part #1), 2) prior to a fresh metastatic biopsy for selection, isolation and partial expansion of PD1+ TILs (Part #2) and 3) prior to allow for remaining study procedures and TILs therapy (Part #3, Main Consent).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek od 18 lat
  • Oczekiwane przeżycie ≥6 miesięcy
  • Potwierdzony nieoperacyjny lub przerzutowy rak piersi typu potrójnie ujemnego
  • Maksymalnie 5 wcześniejszych linii chemioterapii w stadium zaawansowanym
  • Brak innego nowotworu w ciągu ostatnich 3 lat (z wyjątkami)
  • Dobry stan sprawności (ECOG 0-1)
  • Zdolność do przestrzegania wizyt i procedur badania

✗ Disqualifies

  • Ciąża lub karmienie piersią

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
November 24, 2023
Sex
No restrictions

Therapies / drugs in trial

Locations (4)

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital 12 de Octubre

Madrid, Spain

Clínica universidad de Navarra

Pamplona, Spain

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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