OncoMatch/Clinical Trials/NCT05451784
Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS
Is NCT05451784 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies PD1+ TILs (NUMARZU-001) product infusion for metastatic triple-negative breast carcinoma.
Treatment: PD1+ TILs (NUMARZU-001) product infusion — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) mRNA expression above the 20th percentile (above 20th percentile)
PD-1 mRNA expression above the 20th percentile in the FFPE tumor sample analyzed in Part 1
Required: HER2 (ERBB2) negative in situ hybridization test or IHC status of 0 or 1+ (IHC 0 or 1+ or negative ISH)
HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+
Required: ESR1 expression <10% (<10%)
ER and PgR expressions <10% as determined locally by IHC assay
Required: PR (PGR) expression <10% (<10%)
ER and PgR expressions <10% as determined locally by IHC assay
Disease stage
Metastatic disease required
Histologically confirmed diagnosis of unresectable or metastatic breast cancer.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: antibody-drug conjugate
All patients must have received two or more prior systemic therapies, including at least one of them for advanced disease and an ADC.
Cannot have received: allogeneic hematopoietic stem cell transplantation
Patients must NOT have undergone prior allogeneic hematopoietic stem cell transplantation
Lab requirements
Blood counts
Adequate organ function determined within 28 days prior to enrollment.
Kidney function
Adequate organ function determined within 28 days prior to enrollment.
Liver function
Adequate organ function determined within 28 days prior to enrollment.
Cardiac function
For patients ≥ 60 years or with cardiac history, cardiac stress test must show normal LVEF, NYHA < class 1, and any wall movement abnormalities must be reversible. LVEF ≥ 50% at baseline as determined by ECHO or MUGA.
Adequate organ function determined within 28 days prior to enrollment. For patients ≥ 60 years or patients who have a history of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias, a cardiac stress tests must be performed showing normal LVEF, NYHA functional classification < class 1 and if any wall movement abnormalities, they must be reversible. Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO or MUGA
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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