Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS
Status:
Not yet recruiting
Trial end date:
2027-09-30
Target enrollment:
Participant gender:
Summary
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) prior to or during induction therapy 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).