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

Exclusion Criteria17

• 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.
• Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.
• 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.
• 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.
• History of interstitial lung disease, interstitial pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy.
• Allergy to protein drugs or multiple medications.
• 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.
• 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.