MedTrace Logo

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

NCT05451784 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-24

No results posted yet for this study

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).

Conditions

  • Metastatic Triple-Negative Breast Carcinoma

Interventions

DRUG

PD1+ 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).

Sponsors & Collaborators

  • SOLTI Breast Cancer Research Group

    collaborator OTHER

  • Fundacio Clinic Barcelona

    lead OTHER

Principal Investigators

  • Aleix Prat · Hospital Clinic

  • Laura Angelats · Hospital Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2025-11-30
Completion
2027-09-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05451784 on ClinicalTrials.gov