BGT007H Cells for the Treatment of Refractory Digestive System Tumors

Exclusion Criteria

• •1. Active central nervous system metastases (except those stable after treatment);
• •2. HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative detection ≥1000cps/ml), HCV antibody positive and HCV RNA positive;
• •3. Patients with mental or mental illness who cannot cooperate with treatment and efficacy evaluation;
• •4. Subjects with severe autoimmune diseases and long-term use of immunosuppressants;
• •5. Active or uncontrolled infections requiring systemic treatment during the 14 days prior to enrollment;
• •6. Any unstable systemic disease (including but not limited to) :
• •Active infections (except local infections); unstable angina pectoris; cerebral ischemia or cerebrovascular accident (within 6 months prior to screening); myocardial infarction (within 6 months before screening); Congestive heart failure (New York Heart Association \[NYHA\] classification ≥III); Severe arrhythmias requiring medical treatment; have a heart condition that requires treatment or uncontrolled hypertension after treatment (blood pressure \> 160mmHg/100 mmHg);
• •7. dysfunction of important organs such as lung, brain and kidney;
• •8. The subject has undergone major surgery or severe trauma within 4 weeks prior to receiving cell therapy, or is expected to undergo major surgery during the study period;
• •9. Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy within 1-2 weeks prior to anapheresis or within 5 half-lives, whichever is shorter;
• •10. The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical carcinoma in situ or basal cell carcinoma of the skin, and other malignant tumors with disease-free survival of more than 5 years;
• •11. Received chimeric antigen receptor modified T cells (including CAR-T, TCR-T) within six months;
• •12. Graft-versus-host disease (GVHD);
• •13. Participants who were receiving systemic steroid therapy prior to screening and who were determined by the investigator to require long-term use of systemic steroid therapy during treatment (except for inhalation or topical use); And subjects treated with systemic steroids within 72 h prior to cell transfusion (except for inhalation or topical use);
• •14. Severe allergies or history of allergies;
• •15. Subjects requiring anticoagulation therapy;
• •16. Pregnant or breastfeeding women, or have a pregnancy plan within six months (for both men and women)
• •17. Researchers believe that there are other reasons for not being included in the treatment.