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

"The cryopreserved NUMARZU-001 product will be thawed in a 37ºC water bath and will be infused by gravity, a 5 mL to 10 mL/ minute.~Concomitant medications will be given to the patient starting within 24 hours before NUMARZU-001 product infusion. This therapy will include the following:~* Hydration as per institutional standards (Saline solution 0,9% NaCl 500ml every 8 hours) 24 hours before the NUMARZU-001 product infusion.~* Within 30 to 60 minutes before infusion of NUMARZU-001, premedicate the patient with paracetamol (1 g) and dexclorfeniramina (5 mg IV), or another H1- histamine antagonist.~Continuous supervision of the patient by site medical staff is required until completion of infusionof the NUMARZU-001 product, to monitor for potential signs and symptoms (e.g. hypersensitivityreaction)."