A Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of DIT309 Cell Injection in Subjects With Advanced Bone and Soft Tissue Sarcomas
This is a open-Label, dose-escalation study to evaluate the safety, tolerability and antitumor activity of DIT309 in subjects with advanced bone and soft tissue sarcomas.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.
• Voluntarily agrees to participate in the clinical trial; is fully informed about the study and has signed the informed consent form (ICF); is willing and able to comply with all study procedures.
• Male or female patients aged ≥8 weeks.
• Histologically confirmed diagnosis of advanced bone and soft tissue sarcoma, who have failed or are intolerant to prior standard therapies.
• At least one measurable lesion as defined by RECIST version 1.1.
• Tumor tissue demonstrates positive expression for the target antigen according to the protocol-defined criteria.
• ECOG performance status of 0-1 within 24 hours prior to leukapheresis and prior to lymphodepletion.
• Life expectancy of more than 6 months.
• Adequate venous access for leukapheresis, with no contraindications for the procedure.
• Laboratory parameters must meet the following criteria:
∙ Hematologic function: WBC ≥ 3.0 × 10⁹/L; Hemoglobin ≥ 8.0 g/dL; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 75.0 × 10⁹/L
‣ Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
‣ Hepatic function: ALT and AST ≤ 2.5 × ULN (≤ 5.0 × ULN for subjects with liver metastasis)
‣ Total bilirubin ≤ 2.0 × ULN (excluding patients with Gilbert's syndrome, defined as persistent or recurrent unconjugated hyperbilirubinemia without evidence of hemolysis or hepatic pathology)
‣ Coagulation: Without anticoagulation therapy, PT, APTT, or INR ≤ 1.5 × ULN
‣ Negative pregnancy test for female subjects of childbearing potential
⁃ Subjects of childbearing potential must agree to use effective contraception from the date of signing the informed consent through 6 months after the last infusion.