U87 CAR-T in Patients With Advanced Head and Neck Tumors

Prior treatment

• Inadequate washout period from prior anti-cancer treatments before leukapheresis.
• Receipt of live or attenuated vaccines within 4 weeks prior to leukapheresis or planned receipt during the study.
• Major surgery or significant trauma within 4 weeks prior to leukapheresis or planned during the study.
• Previous Trop2-targeted CAR-T/TCR-T cell therapy or other cellular treatments, or therapeutic cancer vaccines.
• Chronic use of systemic corticosteroids or immunosuppressants within 7 days before leukapheresis, except for local, ophthalmic, intra-articular, intranasal, or inhaled treatments.
• Prior treatment-related adverse effects not recovered to CTCAE v5.0 grade ≤1 or specified levels, except for non-safety risk toxicities.
• Other untreated malignancies within 5 years prior to study drug use. History of immune deficiency, hematopoietic stem cell/organ transplantation. Uncontrollable third-space fluid accumulation.

Other illness

• Active infection requiring intravenous anti-infective therapy.
• Positive for HBsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, TP-Ab, HIV antibodies, or elevated EBV-DNA, CMV-DNA.
• Primary immunodeficiency or active autoimmune disease.
• History of interstitial lung disease, interstitial pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy.
• Allergy to protein drugs or multiple medications.
• Severe cardiovascular or cerebrovascular disease history, including NYHA class ≥II heart failure, uncontrolled hypertension, or recent severe events.
  • Pregnant or breastfeeding women.
• Uncontrollable psychiatric history.
• Other conditions deemed unsuitable for study participation by the investigator.

Other

• Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.

• 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.