Actively Recruiting
Safety and Efficacy of DIT309 in Advanced Bone and Soft Tissue Sarcomas
Led by Tcelltech Inc. · Updated on 2026-05-05
15
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
T
Tcelltech Inc.
Lead Sponsor
S
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of DIT309 in Advanced Bone and Soft Tissue Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate, fully informed, and signed consent
- Male or female aged 8 years or older
- Histologically confirmed advanced bone or soft tissue sarcoma with prior standard therapy failure or intolerance
- At least one measurable lesion as per RECIST 1.1
- Tumor tissue shows positive target antigen expression per protocol criteria
- ECOG performance status of 0-1 within 24 hours before leukapheresis and lymphodepletion
- Life expectancy over 6 months
- Adequate venous access for leukapheresis without contraindications
- Laboratory requirements: WBC ≥ 3.0×10⁹/L; Hemoglobin ≥ 8.0 g/dL; ANC ≥ 1.5×10⁹/L; Platelets ≥ 75.0×10⁹/L
- Serum creatinine ≤ 1.5× upper limit of normal (ULN)
- ALT and AST ≤ 2.5× ULN (≤ 5.0× ULN if liver metastasis present)
- Total bilirubin ≤ 2.0× ULN (excluding Gilbert's syndrome)
- Coagulation tests (PT, APTT, INR) ≤ 1.5× ULN without anticoagulation therapy
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception from consent through 6 months after last infusion
You will not qualify if you...
- Pregnant or breastfeeding women
- Positive serology for HIV antibodies or syphilis
- Positive HBsAg or HBcAb with detectable HBV DNA in blood
- Positive HCV antibody with detectable HCV RNA in blood
- Known hypersensitivity to DIT309 or its components (fludarabine, cyclophosphamide, trastuzumab) or history of severe allergic reactions
- Active autoimmune diseases (except vitiligo or childhood asthma in remission without treatment)
- Use or anticipated need for systemic immunosuppressive therapy (topical/inhaled corticosteroids allowed intermittently)
- Prior gene-modified T cell or gene therapy exposure
- Uncontrolled neurological or psychiatric disorders including epilepsy, dementia, major depression
- Untreated or symptomatic CNS or leptomeningeal metastases
- Unresolved toxicities from prior treatments not recovered to Grade ≤1 per CTCAE v5.0 (except alopecia, Grade 2 peripheral neuropathy, or managed hypothyroidism)
- History of other primary solid malignancies
- Major surgery or significant trauma within 1 month before leukapheresis
- Serious or uncontrolled comorbidities increasing participation risk, including cardiovascular, cerebrovascular disease, renal insufficiency, pulmonary embolism, coagulation disorders needing long-term anticoagulation, or active uncontrolled infections requiring systemic treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
R
Rui Feng, MD
CONTACT
X
Xianzhen Chen, MM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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