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

Launched by TCELLTECH INC. · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called DIT309, which is a type of CAR-T cell therapy designed to fight advanced bone and soft tissue sarcomas—types of cancers that affect bones and the soft tissues around them. The main goals are to find out if this treatment is safe, how well patients can tolerate it, and whether it helps shrink tumors. This early-phase study will also determine the best dose to use in future research.

People who might be eligible to join are those aged 8 weeks and older who have advanced sarcomas that have not responded to standard treatments. Their tumors must test positive for a specific marker called B7-H3. Participants need to be in generally good health aside from their cancer, with certain blood and organ functions within safe ranges. During the trial, patients will receive DIT309 and be closely monitored for side effects and any signs of tumor response. It's important to know this study is not yet recruiting, and certain conditions—like pregnancy, active infections, or serious other health problems—may exclude someone from participating. Overall, this trial offers a chance to try a promising new therapy for those with limited treatment options, with careful attention to safety and finding the right dose.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Male or female patients aged ≥8 weeks.
• • 3. Histologically confirmed diagnosis of advanced bone and soft tissue sarcoma, who have failed or are intolerant to prior standard therapies.
• • 4. At least one measurable lesion as defined by RECIST version 1.1.
• • 5. B7-H3-positive tumor confirmed by pathological testing, with B7-H3 positivity defined as ≥20% B7-H3-positive tumor cells in non-necrotic tumor tissue.
• • 6. ECOG performance status of 0-1 within 24 hours prior to leukapheresis and prior to lymphodepletion.
• • 7. Life expectancy of more than 6 months.
• • 8. Adequate venous access for leukapheresis, with no contraindications for the procedure.
• 9. Laboratory parameters must meet the following criteria:
• • 1. Hematologic function: WBC ≥ 3.0 × 10⁹/L; Hemoglobin ≥ 8.0 g/dL; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 75.0 × 10⁹/L
• • 2. Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
• • 3. Hepatic function: ALT and AST ≤ 2.5 × ULN (≤ 5.0 × ULN for subjects with liver metastasis)
• • 4. 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)
• • 5. Coagulation: Without anticoagulation therapy, PT, APTT, or INR ≤ 1.5 × ULN
• • 6. Negative pregnancy test for female subjects of childbearing potential
• • 10. 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.
• Exclusion Criteria:
• • 1. Pregnant or breastfeeding women
• 2. Viral infections:
• • 1. Positive serology for HIV antibodies or syphilis
• • 2. Positive HBsAg or HBcAb with HBV DNA above the lower limit of detection in peripheral blood
• • 3. Positive HCV antibody with detectable HCV RNA in peripheral blood
• 3. Medical history and comorbidities:
• • 1. Known hypersensitivity to DIT309 cells or any component of the investigational products (including fludarabine, cyclophosphamide, or trastuzumab), or history of severe allergic reactions
• • 2. 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
• • 3. Currently receiving systemic immunosuppressive therapy or anticipated need for long-term immunosuppression during the study (topical, inhaled, or intranasal corticosteroids used intermittently are allowed)
• • 4. Prior exposure to any gene-modified T cell therapy (e.g., CAR-T or TCR-T) or any form of gene therapy\*
• • 5. 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
• • 6. Untreated or symptomatic CNS or leptomeningeal metastases
• • 7. 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)
• • 8. History of other primary solid malignancies
• • 9. Major surgery or significant trauma within 1 month prior to leukapheresis
• • 10. 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.