Actively Recruiting
Dual-target CD70/CAIX CAR-NK Cells for Advanced Clear Cell Renal Cell Carcinoma
Led by Beijing Biotech · Updated on 2026-04-24
36
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 1/2 study evaluates the safety, feasibility, and preliminary antitumor activity of allogeneic dual-target CD70/CAIX CAR-NK cells after fludarabine/cyclophosphamide lymphodepletion in adults with advanced or metastatic clear cell RCC that has progressed after standard therapy. The study is designed to determine a recommended dose and schedule, characterize hepatobiliary safety, and explore whether CD70-high, CAIX-high, or dual-high tumors derive the greatest benefit. Biomarker-defined activity signals will be used to guide whether later development should prioritize CD70, CAIX/CA9, or continued dual-targeting.
CONDITIONS
Official Title
Dual-target CD70/CAIX CAR-NK Cells for Advanced Clear Cell Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and willingness to follow study procedures
- Age 18 years or older at consent
- Histologically confirmed unresectable or metastatic clear cell RCC or RCC with clear-cell component with progression after standard therapy
- Prior treatment with at least one PD-1/PD-L1 regimen and one VEGF-pathway targeted therapy or intolerance to standard systemic options
- At least one measurable lesion by RECIST 1.1 criteria
- Available tumor tissue or willingness to undergo biopsy for biomarker testing; tumor must test positive for CD70 and/or CAIX
- ECOG performance status of 0 or 1
- Adequate marrow, liver, heart, lung, and kidney function per protocol
- Life expectancy of at least 12 weeks
- Negative pregnancy test for those of childbearing potential and agreement to use effective contraception during risk periods
- Previously treated brain metastases allowed if stable and off escalating steroids for at least 14 days before lymphodepletion
You will not qualify if you...
- Active, untreated, or symptomatic central nervous system metastases or leptomeningeal disease
- Uncontrolled seizure disorder
- Prior gene-modified cell therapy (CAR-T, CAR-NK, CAR-NKT, or TCR-engineered) within protocol-defined washout
- Prior allogeneic stem cell or solid organ transplant with ongoing significant immunosuppression
- Active autoimmune disease requiring systemic immunosuppression (physiologic replacement allowed)
- Active uncontrolled infections including hepatitis B, C, HIV, tuberculosis, or sepsis
- Significant hepatobiliary disease increasing risk from CAIX therapy (e.g., cholangitis, biliary obstruction, advanced cirrhosis)
- Significant cardiovascular disease (unstable angina, recent heart attack, uncontrolled arrhythmia, heart failure)
- Systemic corticosteroid use over 10 mg prednisone equivalent daily within 7 days before lymphodepletion unless physiologic replacement
- Pregnancy or breastfeeding
- Other invasive cancers requiring systemic treatment except low-risk exceptions
- Known hypersensitivity to fludarabine, cyclophosphamide, or critical study product components
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
shan S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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