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

NCT07052383 | Recruiting Phase 1

• 1 other identifier: DIT309T-IS001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteosarcoma; Soft Tissue Sarcoma

Keywords

Advanced

Outcome Measures

Primary Outcomes (3)

• Safety：Incidence of Dose Limiting Toxicity (DLT)

  Type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first DIT309 infusion.

  28 days after the first DIT309 infusion.

• Safety：Incidence and severity of adverse events (AEs)

  To evaluate the possible adverse events after DIT309 infusion, including the incidence, and severity of AEs.

  1year post CAR-T cells infusion.

• The maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of DIT309.

  The maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of DIT309.

  From first dose of DIT309 until the end of Dose Limiting Toxicity (DLT) observation period (typically 28 days post-infusion for each dose cohort).

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  1 year post CAR-T cells infusion.

• Disease Control Rate (DCR)

  1 year post CAR-T cells infusion.

• Duration of disease control (DDC)

  1 year post CAR-T cells infusion.

• Objective response rate (ORR)

  1 year post CAR-T cells infusion.

• Time to Remission (TTR)

  1 year post CAR-T cells infusion.

Other Outcomes (5)

• The immunogenicity of DIT309

  Up to 12 months

• The positive rate of replication competent lentivirus tests

  Up to 15 years.

• Peak Concentration (Cmax) of DIT309 CAR gene.

  Up to 12 months

Study Arms (1)

Dose Escalation Cohort

EXPERIMENTAL

DIT309 were administered via intravenous reinfusion on Days 1 in a 28-day treatment cycle.

Biological: DIT309 cell injection

Interventions

DIT309 cell injection BIOLOGICAL

Patients receive CAR+ T cells via intravenous infusion on a single day, with pre-specified dose levels determined by the 3+3 dose escalation design detailed in the study protocol.

Dose Escalation Cohort

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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:
• 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
• 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, or major depression
• 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, or hypothyroidism managed with replacement therapy)
• History of other primary solid malignancies
• Major surgery or significant trauma within 1 month prior to leukapheresis

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Tcelltech Inc.: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Osteosarcoma; Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Gangxiong Huang, MD

  Tcelltech Inc.

  STUDY CHAIR

Central Study Contacts

Rui Feng, MD

CONTACT

+(86)13509312934; fengrui@tcelltech.com

Xianzhen Chen, MM

CONTACT

+(86)18649725652; chenxianzhen@tcelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): October 10, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)