In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies

Exclusion Criteria

• •1. Other anti-tumor treatments within the screening period (judged by the investigator comprehensively):
• •① Received chemotherapy, targeted therapy or immunotherapy within 5 half-lives before administration;
• •② Received radiotherapy within 4 weeks before administration (if the radiotherapy target area covers ≤ 5% of bone marrow reserve, the time limit for radiotherapy completion is not restricted);
• •2. History of hematopoietic stem cell transplantation: Received allogeneic or autologous hematopoietic stem cell transplantation within 3 months before administration;
• •3. History of other malignant tumors (except for this disease), except for the following situations:
• •① Received radical treatment and had no known active disease for ≥ 2 years before enrollment;
• •② Had fully treated non-melanoma skin cancer in the past and had no active lesions at present;
• •4. Received treatment related to vesicular stomatitis virus glycoprotein (VSVG) pseudotyped virus in the past;
• •5. Had severe and uncontrolled infections (bacterial, viral, fungal, etc.) within the screening period;
• •6. Clinically significant cardiac diseases:
• •* Had symptomatic heart failure or other serious cardiac diseases (such as severe arrhythmia);
• •* Had New York Heart Association (NYHA) Class III-IV congestive heart failure; ③ Had a myocardial infarction or received coronary artery bypass grafting (CABG) / coronary artery stent implantation within 6 months before signing the informed consent;
• •* Had clinically significant ventricular arrhythmia or a history of unexplained syncope; ⑤ Had a history of syncope (excluding cases caused by vasovagal reactions or dehydration); ⑥ Had a history of severe non-ischemic cardiomyopathy;
• •7. Other clinically significant diseases, including but not limited to:
• •* Primary immunodeficiency; ② Had a stroke or seizure within 6 months before screening;
• •* Had clear clinical evidence of dementia or mental status changes; ④ Had Parkinson's disease, Parkinson-like movement disorders or a history of the above;
• •8. Had undergone surgery within 2 weeks before administration, or planned to undergo surgery within 2 weeks after administration (local anesthesia surgery excluded);
• •9. Had received live attenuated vaccines within 1 month before administration;
• •10. Had a history of severe allergic reactions to this product or its formulation components;
• •11. Patients who were not suitable for establishing intravenous access;
• •12. The investigator believed that there were other conditions that made the patient unsuitable for participating in this study.