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New treatment option for Metastatic Triple-Negative Breast Carcinoma
Official title Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS
ClinicalTrials.gov ID: NCT05451784
What this study is testing
What is PD1+ TILs (NUMARZU-001) product infusion?
PD1+ TILs (NUMARZU-001) product infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic triple-negative breast carcinoma.
Also referred to as TILs.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility criteria for Part #1 (Molecular pre-screening: Determination of PD1 by mRNA analysis from an archival FFPE tumor sample): Participants...
- 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...
See the full eligibility criteria
- Eligibility criteria for Part #1 (Molecular pre-screening: Determination of PD1 by mRNA analysis from an archival FFPE tumor sample): Participants are eligible to be included in the study only if all of the following...
- 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...
- Patients could have received a maximum of 5 lines of prior standard of care chemotherapy in the inoperable/metastatic setting.
- Patients must not have history of other malignancy within the past 3 years with the following exceptions: adequately treated non-melanoma skin cancer without evidence of disease at the time of enrollment; adequately...
- Subject likely to be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
- Absence of psychiatric or physiologic history, substance abuse, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be...
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Pregnant or breastfeeding women will NOT be eligible.
- Subject has known sensitivity to any of the products or components to be administered during dosing will NOT be eligible.
- NOT having an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or sponsor staff directly involved in this trial, unless prospective institutional review board...
- Patients must NOT have undergone prior allogeneic hematopoietic stem cell transplantation
- Patients with a history or evidence of symptomatic autoimmune will NOT be eligible: glomerulonephritis, vasculitis, or other symptomatic autoimmune diseases, or active autoimmune disease or syndrome that has required...
- Absence of active bacillus tuberculosis history.
- Absence of a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required.
- Absence of a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. Note: no testing for Hepatitis B and...
- To be able to provide either a newly obtained tumor biopsy (preferred) or archival tumor tissue of an FFPE tumor block. The tumor tissue should be of good quality based on total and viable tumor content and must be...
- Patients will be eligible for Part #2 if they have a PD-1 mRNA expression above the 20th percentile in the FFPE tumor sample analyzed in Part 1.
- At least 1 resectable target lesion
- Patients must NOT have clinically active cerebral metastases. Carcinomatous meningitis is not allowed regardless of clinical stability. Eligibility criteria for Part #3 (Screening and treatment Phase: Complete expansion...
- PD1+ TILs selection in Part #1 and successful partial expansion of tumor sample in Part #2
- Treatment-related toxicities (except alopecia and neuropathy G2) must ≤ Grade 1 at the time of allocation according to CTCAE version 5.0.
- All patients must have received two or more prior systemic therapies, including at least one of them for advanced disease and an ADC. A maximum of five chemotherapy-based lines are permitted in the metastatic setting...
- Measurable disease according to RECIST 1.1 criteria.
- Adequate organ function determined within 28 days prior to enrollment.
- Female people of childbearing potential must have a negative urine or serum pregnancy test within 72 hours 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...
- Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO or MUGA
- Patients must not be currently receiving treatment with another investigational device or drug study. No other investigational procedures (of any kind) are permitted while participating in this study.
- Systemic steroid therapy is not permitted (patients who require replacement therapy for adrenal insufficiency may be enrolled if the steroid treatment dose does not exceed 10 mg of prednisone or equivalent).
- Patients with evidence of clinically significant immunosuppression will NOT be eligible.
- Patients with evidence of (non-infectious) pneumonitis that required steroids or current pneumonitis will NOT be eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
- Madrid, Spain
- Pamplona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain; Madrid, Spain; Pamplona, Spain. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.