RecruitingPhase 1NCT07052383

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

A Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of DIT309 Cell Injection in Subjects With Advanced Bone and Soft Tissue Sarcomas

Sponsor

Tcelltech Inc.

Enrollment

15 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma Osteosarcoma

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.

Eligibility

Min Age: 8 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called DIT309 cell injection for people with osteosarcoma and soft tissue sarcoma. The study is currently recruiting participants at 1 location. People eligible for this study include aged 8 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALDIT309 cell injection

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.