Actively Recruiting
Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma
Led by Beijing Biotech · Updated on 2026-03-25
42
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This hypothetical first-in-human study is designed to evaluate the safety, feasibility, and preliminary anti-tumor activity of an allogeneic dual-target Nectin-4/HER2 CAR-NK cell product in adults with relapsed/refractory locally advanced or metastatic urothelial carcinoma. Based on public urothelial-cancer evidence, Nectin-4 was selected as the lead antigen because it has the strongest disease-specific clinical validation; HER2/ERBB2 was chosen as the secondary co-target to broaden tumor coverage and reduce antigen-escape risk. EpCAM is not selected as a therapeutic co-target in this example because of broader normal epithelial expression and weaker tumor specificity in urothelial carcinoma.
CONDITIONS
Official Title
Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at consent
- Histologically confirmed unresectable locally advanced or metastatic urothelial carcinoma of the bladder, ureter, renal pelvis, or urethra
- Disease progression after, intolerance to, or ineligibility for standard therapy including platinum-based chemotherapy and PD-1/PD-L1 blockade
- Prior enfortumab vedotin and HER2-directed therapy allowed; fresh biopsy preferred after latest systemic therapy
- At least one measurable lesion per RECIST v1.1
- Tumor tissue available showing Nectin-4 positivity and HER2 status assessed, with at least one target present
- ECOG performance status of 0 or 1
- Adequate bone marrow, liver, kidney, and coagulation function
- Life expectancy of at least 12 weeks
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during treatment and follow-up
- Ability to understand and sign informed consent
You will not qualify if you...
- Active or untreated central nervous system metastases or leptomeningeal disease; stable treated CNS disease allowed
- Prior allogeneic hematopoietic stem cell transplant, prior solid-organ transplant, or active graft-versus-host disease
- Clinically significant autoimmune disease requiring systemic immunosuppression within washout window
- Uncontrolled infections including hepatitis B, hepatitis C, HIV, sepsis, or active tuberculosis
- Clinically significant cardiac disease or recent cardiac events increasing risk from HER2 therapy
- Clinically significant pulmonary disease such as uncontrolled interstitial lung disease or oxygen dependence
- Use of systemic corticosteroids or immunosuppressive medications above protocol limits within washout window
- History of severe hypersensitivity to fludarabine, cyclophosphamide, or cell-product components
- Pregnancy or breastfeeding
- Another active malignancy requiring systemic therapy or likely to interfere with study assessments, except low-risk cancers allowed
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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