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

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 a

Trial Details

NCT ID
NCT05451784
Phase
PHASE1 / PHASE2
Sponsor
Fundacio Clinic Barcelona
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • PD1+ TILs (NUMARZU-001) product infusion
Locations (sample)
  • Barcelona, Spain|41.38879,2.15899
  • Barcelona, Spain|41.38879,2.15899
  • Madrid, Spain|40.4165,-3.70256
  • Pamplona, Spain|42.81687,-1.64323

Key Eligibility Criteria

  • Eligibility criteria for Part #1 (Molecular pre-screening: Determination of PD1 by mRNA analysis from an archival FFPE tumor sample):
  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Age ≥ 18 years.
  • Estimated life expectancy of ≥6 months.

For full eligibility, visit ClinicalTrials.gov.

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