RecruitingPhase 1Phase 2NCT05451784

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

Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ Tumor-infiltrating Lymphocytes (TILS001 Trial)

Sponsor

Fundacio Clinic Barcelona

Enrollment

20 participants

Start Date

Jul 20, 2022

Study Type

INTERVENTIONAL

Conditions

Metastatic Triple-Negative Breast Carcinoma

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) 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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a type of immune cell therapy called adoptive T-cell therapy — where immune cells are collected from a patient, supercharged in a lab, and then infused back — for people with advanced or metastatic triple-negative breast cancer (TNBC), which is an aggressive type of breast cancer that lacks the three most common treatment targets. **You may be eligible if...** - You have been diagnosed with triple-negative breast cancer (TNBC) - Your cancer is advanced (locally advanced or metastatic, meaning it has spread) - You have received prior chemotherapy - Your general health is adequate for receiving cell therapy - You are 18 or older **You may NOT be eligible if...** - You have active autoimmune conditions that could be worsened by immune therapy - You have significant heart, lung, liver, or kidney problems - You are pregnant or breastfeeding - You have had a prior organ transplant - You have active infections including HIV or hepatitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD1+ TILs (NUMARZU-001) product infusion

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).

Locations(4)

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital 12 de Octubre

Madrid, Spain

Clínica universidad de Navarra

Pamplona, Spain

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