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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacio Clinic Barcelona

About this 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).

Eligibility criteria

Qualifiers

Age ≥ 18 years.

Estimated life expectancy of ≥6 months.

Histologically confirmed diagnosis of unresectable or metastatic breast cancer.

Histologically confirmed diagnosis of advanced triple-negative breast cancer (based on the most recently analyzed biopsy from locally recurrent or metastatic site, local laboratory) meeting the following criteria: HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+, and ER and PgR expressions <10% as determined locally by IHC assay as per most recent ASCO/CAP guidelines.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • PD1+ TILs (NUMARZU-001) product infusion

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

4
Hospital Clinic de Barcelona08036, Barcelona Spain
Hospital Universitari Vall d'Hebrón08035, Barcelona Spain
Hospital 12 de Octubre28041, Madrid Spain
Clínica universidad de Navarra31008, Pamplona Spain

Sponsors and collaborators

Fundacio Clinic Barcelona

Lead sponsor

SOLTI Breast Cancer Research Group

Collaborator