Clinical Study of a Novel Humanized CD70-Targeted CAR-T Cell Incorporating TLR2 for Advanced Renal Cell Carcinoma Therapy

Launched by WEI GUAN · Aug 7, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new kind of treatment for people with advanced kidney cancer (renal cell carcinoma) that has not responded to previous treatments. The treatment uses specially modified immune cells called CAR-T cells, which are taken from the patient’s blood, changed in the lab to better recognize cancer cells, and then put back into the body to help fight the cancer. This study aims to see if this new approach is safe and if it can help control the cancer.

To join the trial, participants need to be adults between 18 and 75 years old who have advanced kidney cancer that has returned or continued to grow despite prior treatments. Their cancer must test positive for a specific marker called CD70. People must also be healthy enough for the procedures involved and agree to use birth control during and after the study if applicable. During the trial, participants will have their immune cells collected, receive the modified cells through an infusion, and then be closely monitored through exams, scans, and questionnaires to check how well the treatment works and to watch for any side effects. This is an early-phase study, so the main focus is on safety and understanding the treatment’s effects over time.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntary participation with written informed consent provided by the patient or legally authorized representative;
• • 2.Age 18-75 years (inclusive) at the time of consent, regardless of sex;
• * 3.Advanced-stage renal cell carcinoma (RCC) with no curative treatment options, who have received ≥1 prior line of therapy and meet one or more of the following:
• • 1. Recurrence after first-line or later-line treatment(s).
• • 2. Progression or persistent progression following prior therapy;
• • 4.Histopathologically confirmed advanced RCC per WHO 2016 classification, with at least one measurable lesion evaluable by CT or MRI;
• • 5.CD70 positivity in tumor tissue confirmed by immunohistochemistry (IHC);
• • 6.Adequate organ function: Hepatic: ALT/AST \<3× ULN and total bilirubin ≤34.2 μmol/L. Renal: Creatinine clearance (Cockcroft-Gault) ≥60 mL/min. Pulmonary: Oxygen saturation ≥95% with no active pulmonary infection. Cardiac: LVEF ≥50%, no significant pericardial effusion, and no clinically relevant ECG abnormalities;
• • 7.Contraception: Women of childbearing potential must have a negative pregnancy test (urine/serum) at screening and agree to use effective contraception for ≥1 year post-infusion.
• • Men with partners of childbearing potential must use barrier contraception for ≥1 year post-infusion;
• • 8.Performance status: ECOG score 0-3;
• • 9.Life expectancy \>3 months;
• • 10.Willingness to comply with leukapheresis, medical assessments, and follow-up visits.
• Exclusion Criteria:
• • 1.Pregnant or lactating women;
• • 2.Uncontrolled fungal, bacterial, Treponema pallidum, viral, or other infections;
• • 3.Active hepatitis: HBV DNA \>500 IU/mL. Positive HCV RNA (confirmed by repeat testing);
• • 4.HIV infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
• • 5.Prior gene therapy of any form;
• • 6.History of severe allergic reactions to biologics (including antibiotics), antibodies, cytokines, or other macromolecular agents;
• • 7.Clinically significant CNS disorders: epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndrome;
• • 8.Uncontrolled psychiatric illness;
• • 9.Substance abuse/addiction;
• • 10.Prohibited medications/treatments: Corticosteroids: ≥2 mg/kg prednisone (or equivalent \>20 mg/day) within 2 weeks before leukapheresis.
• • Chemo/radiotherapy: Anti-tumor radiotherapy or salvage chemotherapy within 3 weeks before leukapheresis.
• • Immunosuppressants: Use within 4 weeks before leukapheresis. Other trials/major surgery: Participation in another clinical trial or major non-diagnostic surgery within 4 weeks before leukapheresis.
• • Specific agents: Alemtuzumab within 6 months, or clofarabine/cladribine within 3 months before leukapheresis.