NCT07551349 Dual-target CD70/CAIX CAR-NK Cells for Advanced Clear Cell Renal Cell Carcinoma
| NCT ID | NCT07551349 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing Biotech |
| Condition | Advanced or Metastatic Clear Cell Renal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2027-04-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2026-02-02 with a primary completion date of 2027-04-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Active, untreated, or symptomatic central nervous system metastases, leptomeningeal disease, or uncontrolled seizure disorder. * 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. * 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 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. * Clinically significant cardiovascular disease (for example, unstable angina, recent myocardial infarction, uncontrolled arrhythmia, or clinically meaningful heart failure). * Systemic corticosteroid use greater than 10 mg prednisone equivalent daily within 7 days before lymphodepletion, unless required as physiologic replacement. * Pregnancy or breastfeeding. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07551349 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced or Metastatic Clear Cell Renal Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07551349 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07551349 currently recruiting?
Yes, NCT07551349 is actively recruiting participants. Contact the research team at Seni-Lu@beijing-biotech.com for enrollment information.
Where is the NCT07551349 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT07551349 clinical trial?
NCT07551349 is sponsored by Beijing Biotech. The trial plans to enroll 36 participants.