A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U87 in Patients With Advanced Malignant Head and Neck Tumors
This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors.
• Subjects have provided informed consent, understanding the study\'s risks and benefits, and are willing to complete the study procedures.
• Age between 18 and 70 years old at the time of consent, inclusive, and open to both genders.
• ECOG performance status of 0-1.
• Anticipated survival of at least 12 weeks.
• Histologically or cytologically confirmed advanced malignant head and neck cancer patients with no effective standard treatments available
• Positive Trop2 expression (intensity ≥2+, expression rate ≥40%) in tumor tissue samples within 2 years prior to consent or from recent biopsies.
• At least one measurable tumor lesion according to RECIST 1.1.
• Suitable venous access for mononuclear cell collection.
• Adequate major organ function.
⁃ Negative pregnancy test for women of reproductive age at screening; sexually active subjects must agree to use effective contraception during the study and for one year after the last CAR-T cell infusion.