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
Sponsors and collaborators
Fundacio Clinic Barcelona
Lead sponsor
SOLTI Breast Cancer Research Group
Collaborator