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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
PD1+ TILs (NUMARZU-001) product infusion
DrugThe 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).
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: PD1+ TILs (NUMARZU-001) product infusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of grade 3-5 adverse event (AE)
Incidence of grade 3-5 adverse event (AE) assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 5.0, and any grade AE assessed by CTCAE that leads to treatment discontinuation and possibly related to treatment, that occur in the first 24h following PD1+ TILs infusion (prior to IL-2 treatment). * Incidence of grade 3-5 AEs assessed by the NCI CTCAE version 5.0 taking into account the whole process, which includes NMA-LD chemotherapy followed by TILs infusion and at least one dose of IL-2 treatment. * All changes in treatment administration including delays, interruptions, reductions or discontinuation and the main reason(s) for these changes.
Time frame
24 weeks from the administration of PD1+ TILS (NUMARZU-001 product)2
Overall response rate (ORR)
Overall response rate (ORR) locally determined as the best response (defined as CR and PR) by the investigator according to RECIST 1.1 criteria from the administration of PD1+ TILS (NUMARZU-001 product); on day 0
Time frame
24 weeks from the administration of PD1+ TILS (NUMARZU-001 product)Secondary outcomes
1
Progression-Free Survival at 6 months(PFS6)
Progression-Free Survival at 6 months(PFS6) defined as the proportion of patients alive and without progression (as determined locally by the investigator according to Response Evaluation Criteria in Solid Tumor \[RECIST\] 1.1 version) 24 weeks from the administration of PD1+ TILS (NUMARZU-001 product); on day 0
Time frame
24 weeks from the administration of PD1+ TILS (NUMARZU-001 product)2
Clinical Benefit Rate at 6 months (CBR6)
Clinical Benefit Rate at 6 months (CBR6) from the administration of PD1+ TILS (NUMARZU-001 product); on day 0 defined as Complete response (CR), Partial response (PR) or Stable Disease (SD) for at least 6 months, as determined locally by the investigator according to RECIST 1.1 criteria.
Time frame
24 weeks from the administration of PD1+ TILS (NUMARZU-001 product)3
Duration of Response (DoR)
Duration of Response (DoR) defined as the time from the first occurrence of a documented objective response to disease progression, as determined locally by the investigator using RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame
24 weeks from the administration of PD1+ TILS (NUMARZU-001 product)4
Progression-free survival (PFS)
Progression-free survival (PFS) defined as the timefrom the administration of PD1+ TILS (NUMARZU-001 product); on day 0 to the first occurrence of disease progression, as determined locally by the investigator using RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame
24 weeks from the administration of PD1+ TILS (NUMARZU-001 product)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundacio Clinic Barcelona
Lead sponsor
SOLTI Breast Cancer Research Group
Collaborator
Source ClinicalTrials.gov