CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors

Exclusion Criteria

• •Women who are pregnant or breastfeeding.
• •Positive hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) with peripheral HBV DNA levels above the lower limit of detection.
• •Positive hepatitis C virus (HCV) antibody with peripheral HCV RNA levels above the lower limit of detection.
• •Positive HIV antibody.
• •Positive syphilis-specific and non-specific antibody tests.
• •Non-hematological toxicity from prior treatment (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) has not resolved to ≤ CTCAE grade 1 (except for hair loss and peripheral sensory neuropathy).
• •Prior allogeneic tissue or organ transplant (including bone marrow, stem cell, liver, kidney, etc.), except for transplants not requiring immunosuppression (e.g., corneal or hair transplantation).
• •Patients who have previously received CDH17 CAR-T therapy, except those who received CAR-T infusion within this study.
• •Underwent major surgery within 4 weeks prior to signing informed consent and has not fully recovered, or has a history of serious unresolved trauma.
• •Known central nervous system (CNS) metastases (with exceptions for asymptomatic brain metastases or stable clinical symptoms).
• •Severe active infections or pulmonary diseases requiring systemic corticosteroid treatment within 6 months prior to signing informed consent.
• •Symptomatic congestive heart failure (NYHA class II-IV), severe aortic stenosis, or symptomatic mitral stenosis.
• •ECG showing QTc \> 450 ms or QTc \> 480 ms with bundle branch block.
• •Uncontrolled hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg).
• •Cerebrovascular accidents within 6 months prior to signing informed consent.
• •Active, chronic, or recurrent severe autoimmune diseases requiring immunosuppressive treatment (with exceptions).
• •Any form of primary or secondary immunodeficiency.
• •Risk of organ perforation or bleeding as judged by the investigator.
• •Severe systemic hypersensitivity reactions to study drugs/components. - Received live attenuated vaccines within 4 weeks prior to signing informed consent.
• •Participated in another clinical study within 4 weeks prior to signing informed consent.
• •History of another malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer or in situ cancers.
• •Diagnosed with neuropsychiatric disorders or any condition deemed by the investigator as unsuitable for participation.