Safety and Efficacy of DIT309 in Advanced Bone and Soft Tissue Sarcomas (NCT07052383) | Clinical Trial Compass
RecruitingPhase 1
Safety and Efficacy of DIT309 in Advanced Bone and Soft Tissue Sarcomas
China15 participantsStarted 2025-11-06
Plain-language summary
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.
Who can participate
Age range8 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
✕
What they're measuring
1
Safety：Incidence of Dose Limiting Toxicity (DLT)
Timeframe: 28 days after the first DIT309 infusion.
2
Safety：Incidence and severity of adverse events (AEs)
Timeframe: 1year post CAR-T cells infusion.
3
The maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of DIT309.
Timeframe: From first dose of DIT309 until the end of Dose Limiting Toxicity (DLT) observation period (typically 28 days post-infusion for each dose cohort).
. 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