Donor-Derived Natural Killer Cells Aimed at Two Targets for Advanced Kidney Cancer
Tests engineered donor immune cells in adults with advanced clear cell kidney cancer.
Plain-language title generated from the registry record
Registry title: Dual-target CD70/CAIX CAR-NK Cells for Advanced Clear Cell Renal Cell Carcinoma
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with clear cell kidney cancer that is advanced or has spread and has worsened after standard treatment. Their tumor must test positive for CD70 and/or CAIX.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Clear cell renal cell carcinoma (or kidney cancer with a clear-cell part) that cannot be removed by surgery or has spread, and has grown on scans after standard therapy. At least one tumor measurable by RECIST 1.1.
- Earlier treatment
- Must have had at least one PD-1/PD-L1-based treatment and at least one VEGF-pathway targeted treatment, or be unable to take or tolerate the standard options. Previously treated brain metastases are allowed if stable and off rising steroid doses for at least 14 days before lymphodepletion.
- Biomarker or test result
- Tumor must test positive for CD70 and/or CAIX (CA9), as defined by the protocol. Tumors positive for both are preferred for the biomarker expansion part. Archival tissue or a fresh biopsy is needed for testing.
Main reasons for not taking part
- Active, untreated or symptomatic brain or spinal fluid metastases, or uncontrolled seizures
- Earlier gene-modified cell therapy (such as CAR-T or CAR-NK) within the protocol washout window
- Stem cell or organ transplant with ongoing significant immunosuppression
- Active uncontrolled infection, including hepatitis B, hepatitis C, HIV or tuberculosis
- Pregnancy or breastfeeding
Read by machine on 13 November 2026.
Where in China
- Peking University Shenzhen HospitalShenzhen, ChinaContact: Zhen J Peng, PhdTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing Biotech
- Trial code
- NCT07551349
- Record updated
- 24 April 2026
- Original description
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.Read full original descriptionShow less
An Open-Label, Multicenter, Phase 1/2 Study of Allogeneic Dual-target CD70/CAIX (CA9) Chimeric Antigen Receptor Natural Killer Cells in Adults With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
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.
Inclusion: Written informed consent and willingness to comply with protocol procedures; Age >= 18 years at the time of consent; Histologically confirmed unresectable or metastatic clear cell RCC, or RCC with a clear-cell component, with radiographic progression after standard therapy; Prior exposure to at least one PD-1 / PD-L1-based regimen and at least one VEGF-pathway targeted regimen, or documented intolerance / unsuitability for available standard systemic options; At least one measurable lesion by RECIST 1.1; Available archival tumor tissue or willingness to undergo fresh biopsy for central biomarker testing; protocoldefined tumor positivity for CD70 and/or CAIX is required. Dual-positive cases are preferred for the biomarkerexpansion portion; ECOG performance status 0-1; Adequate marrow, liver, cardiac, pulmonary, and renal function as defined by the protocol (for example, ANC, platelets, bilirubin, AST/ALT, creatinine clearance, oxygen saturation, and left ventricular function within protocoldefined limits); Life expectancy of at least 12 weeks; Negative pregnancy test for participants of childbearing potential and agreement to highly effective contraception during protocol-defined risk windows; Previously treated brain metastases are allowed if clinically stable and off escalating corticosteroids for at least 14 days before lymphodepletion.
Exclusion: Prior gene-modified cellular therapy (including prior CAR-T, CAR-NK, CAR-NKT, or TCR-engineered therapy) within the protocol-defined washout window; Prior allogeneic stem cell transplant or solid organ transplant with ongoing clinically significant immunosuppression; Clinically significant hepatobiliary disease that could increase risk from CAIX-directed therapy, such as active cholangitis, primary sclerosing cholangitis, biliary obstruction, Child-Pugh B/C cirrhosis, or prior hepatic venoocclusive disease; Systemic corticosteroid use greater than 10 mg prednisone equivalent daily within 7 days before lymphodepletion, unless required as physiologic replacement; Active, untreated, or symptomatic central nervous system metastases, leptomeningeal disease, or uncontrolled seizure disorder; Active autoimmune disease requiring systemic immunosuppressive treatment; physiologic replacement doses are permitted; Active uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, HIV, tuberculosis, or sepsis; Clinically significant cardiovascular disease (for example, unstable angina, recent myocardial infarction, uncontrolled arrhythmia, or clinically meaningful heart failure); Another active invasive malignancy requiring systemic treatment, except for protocol-defined low-risk exceptions; Known hypersensitivity to fludarabine, cyclophosphamide, or a critical study-product excipient; Pregnancy or breastfeeding.