Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer

Exclusion Criteria

• •1. Prior Radiotherapy: Receipt of radiotherapy within 3 weeks before treatment initiation (except for palliative reasons).
• •2. CNS Metastases: Known history or presence of central nervous system (CNS) metastases at screening. Patients with clinical suspicion of CNS metastases must undergo contrast-enhanced CT or MRI within 28 days prior to the first dose to rule out CNS involvement.
• •3. Cardiac Disease: History of clinically significant or uncontrolled cardiac conditions, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia.
• •4. Persistent Toxicity: Ongoing ≥ Grade 1 adverse reactions from previous treatments, except for alopecia or conditions deemed acceptable by the investigator. Such exceptions must be clearly documented in the investigator's notes.
• •5. Recent Major Surgery: Undergone major surgery (excluding minor outpatient procedures such as vascular access placement) within 3 weeks before the first cycle of study treatment.
• •6. Pregnancy or Lactation: Patients who are pregnant or breastfeeding.
• •7. Other Malignancies: History of other malignant tumors within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
• •8. Impaired Drug Absorption: Conditions affecting oral drug intake and absorption, such as dysphagia, chronic diarrhea, or intestinal obstruction.
• •9. Uncontrolled Effusions: Uncontrolled third-space effusions (e.g., significant pleural or ascitic fluid) not manageable by drainage or other methods.
• •10. Non-Healing Conditions: Long-term non-healing wounds or incompletely healed fractures.
• •11. Active Viral Hepatitis: Active HBV or HCV infection (HBV-DNA ≥ 500 IU/mL) or chronic hepatitis with abnormal liver function.
• •12. Allergic History: Known allergy or hypersensitivity to any component of the study regimen, or history of hypersensitivity to other monoclonal antibodies.
• •13. Eosinophilia/Mastocytosis: Patients with eosinophilia or mastocytosis.
• •14. Steroid Use: Chronic use of oral corticosteroids. Occasional past use requires a 4-week washout period before enrollment.
• •15. Prior Use of Specific Therapies: Previous treatment with PD-1/TGF-β bispecific antibody, PD-1/CTLA-4 bispecific antibody, PD-1/VEGF bispecific antibody, or anti-HER2 dual-epitope ADC; or use of ADC agents in ≥2 prior lines of therapy.