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New treatment option for Breast Cancer (Advanced/Metastatic)
Official title Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC
ClinicalTrials.gov ID: NCT07510802
What this study is testing
What is Dual-target CAR-NK cells?
Dual-target CAR-NK cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer (advanced/metastatic).
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 study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer. After a tumor antigen assessment (HER2/ERBB2, MUC1, ROR1,TNBC cases mesothelin), each participant will receive the most suitable dual-target CAR-NK product for their tumor profile, following short-course lymphodepleting chemotherapy.
- 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 to 75
You may be able to join if
- Histologically confirmed breast carcinoma that is locally advanced, unresectable, or metastatic.
- Disease subtype: HER2-positive breast cancer or triple-negative breast cancer (TNBC).
- Progression after, intolerance to, or ineligibility for standard therapies appropriate for the disease subtype and line of therapy.
- At least one measurable lesion per RECIST v1.1.
- Tumor antigen assessment available (fresh or archival): expression of at least one candidate target antigen (HER2/ERBB2, MUC1, or ROR1). For TNBC...
You likely can't join if
- Active, untreated central nervous system (CNS) metastases or leptomeningeal disease. Patients with treated CNS metastases may be eligible if...
- Prior gene-modified cellular therapy (e.g., CAR-T or CAR-NK) within 6 months or unresolved grade ≥ 2 toxicity from prior cellular therapy.
- Clinically significant active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement permitted).
- Uncontrolled infection, including uncontrolled HBV, HCV, or HIV infection (controlled infections may be eligible per investigator).
- History of severe hypersensitivity to fludarabine or cyclophosphamide.
- Pregnant or breastfeeding.
See the full eligibility criteria
- Histologically confirmed breast carcinoma that is locally advanced, unresectable, or metastatic.
- Disease subtype: HER2-positive breast cancer or triple-negative breast cancer (TNBC).
- Progression after, intolerance to, or ineligibility for standard therapies appropriate for the disease subtype and line of therapy.
- At least one measurable lesion per RECIST v1.1.
- Tumor antigen assessment available (fresh or archival): expression of at least one candidate target antigen (HER2/ERBB2, MUC1, or ROR1). For TNBC, mesothelin assessment may be performed for exploratory analyses.
- ECOG performance status 0-1.
- Adequate organ function (example thresholds): ANC ≥ 1.0 x 10\^9/L; platelets ≥ 75 x 10\^9/L; hemoglobin
- 8 g/dL; AST/ALT ≤ 3x ULN (≤ 5x with liver metastases); total bilirubin ≤ 1.5x ULN; creatinine clearance
- 50 mL/min.
- Left ventricular ejection fraction (LVEF) ≥ 45% and no uncontrolled cardiac arrhythmia.
- Negative pregnancy test for participants of childbearing potential; agreement to use effective contraception during study treatment and for 6 months after last CAR-NK infusion.
- Ability to understand and willingness to sign informed consent.
- Active, untreated central nervous system (CNS) metastases or leptomeningeal disease. Patients with treated CNS metastases may be eligible if clinically stable for ≥ 4 weeks and off high-dose steroids.
- Prior gene-modified cellular therapy (e.g., CAR-T or CAR-NK) within 6 months or unresolved grade ≥ 2 toxicity from prior cellular therapy.
- Clinically significant active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement permitted).
- Uncontrolled infection, including uncontrolled HBV, HCV, or HIV infection (controlled infections may be eligible per investigator).
- History of severe hypersensitivity to fludarabine or cyclophosphamide.
- Pregnant or breastfeeding.
- Concurrent participation in another treatment study that could confound safety or how well it works assessments.
- Any condition that, in the investigator's judgment, would make the participant unsuitable for the study (e.g., uncontrolled comorbidity, inability to comply with protocol procedures).
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.