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Tests treatment safety and results for Osteosarcoma
Official title Safety and Efficacy of DIT309 in Advanced Bone and Soft Tissue Sarcomas
ClinicalTrials.gov ID: NCT07052383
What this study is testing
What is DIT309 cell injection?
DIT309 cell injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for osteosarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older
You may be able to join if
- Voluntarily agrees to participate in the clinical trial; is fully informed about the study and has signed the informed consent form (ICF); is willing...
- 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.
You likely can't join if
- 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:
See the full eligibility 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.
- 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 people 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 people of childbearing potential
- people of childbearing potential must agree to use effective contraception from the date of signing the informed consent through 6 months after the last infusion.
- 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); people with vitiligo or childhood asthma in complete remission and not requiring treatment in adulthood may be eligible; people...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.