Safety and Efficacy of DIT309 in Advanced Bone and Soft Tissue Sarcomas

Exclusion Criteria16

• Pregnant or breastfeeding women
• Viral infections:
• Positive serology for HIV antibodies or syphilis
• Positive HBsAg or HBcAb with HBV DNA above the lower limit of detection in peripheral blood
• Positive HCV antibody with detectable HCV RNA in peripheral blood
• Medical history and comorbidities:
• Known hypersensitivity to DIT309 cells or any component of the investigational products (including fludarabine, cyclophosphamide, or trastuzumab), or history of severe allergic reactions
• Known active autoimmune diseases (e.g., Crohn's disease, systemic lupus erythematosus); subjects with vitiligo or childhood asthma in complete remission and not requiring treatment in adulthood may be eligible; subjects requiring medical intervention such as bronchodilators for asthma are not eligible
• Currently receiving systemic immunosuppressive therapy or anticipated need for long-term immunosuppression during the study (topical, inhaled, or intranasal corticosteroids used intermittently are allowed)
• Prior exposure to any gene-modified T cell therapy (e.g., CAR-T or TCR-T) or any form of gene therapy*
• History of uncontrolled neurological or psychiatric disorders that may increase the risk of participation or interfere with study results in the investigator's opinion, including but not limited to epilepsy, dementia, or major depression
• Untreated or symptomatic CNS or leptomeningeal metastases
• Unresolved toxicities from prior treatment that have not recovered to Grade ≤1 per CTCAE v5.0 (except for toxicities deemed not to pose safety risk by the investigator, such as alopecia, Grade 2 peripheral neuropathy, or hypothyroidism managed with replacement therapy)
• History of other primary solid malignancies
• Major surgery or significant trauma within 1 month prior to leukapheresis
• Any serious or uncontrolled comorbidity that, in the investigator's opinion, may increase risks associated with study participation or investigational drug administration, including but not limited to: cardiovascular or cerebrovascular disease, renal insufficiency, pulmonary embolism, coagulation disorders requiring long-term anticoagulation, active or uncontrolled infections requiring systemic treatment.