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Study identifier: NCT05451784 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Metastatic Triple-Negative Breast Carcinoma  ·  Sponsor: Fundacio Clinic Barcelona

PhasePhase 1/Phase 2
Planned participants20
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Tomás Pascual  ·  + 34 933 436 302  ·  tomas.pascual@gruposolti.org

Laura Angelats  ·  LANGELATS@clinic.cat

Always discuss trial participation with your own doctor first.

Locations (4)

Hospital Universitari Vall d'HebrónBarcelona, SpainRecruiting
Hospital Clinic de BarcelonaBarcelona, SpainRecruiting
Hospital 12 de OctubreMadrid, SpainRecruiting
Clínica universidad de NavarraPamplona, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT05451784