NCT07052383

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Tcelltech Inc. · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects will be enrolled to receive DIT309 via intravenous infusion. Patients will be administered DIT309 on Day 1 of each 28-day treatment cycle, followed by a 28-day observation period. The study will include three escalating dose levels, utilizing a traditional 3+3 dose escalation design. Each dose level will enroll 3 to 6 patients. Dose-limiting toxicities (DLTs) will be assessed during the first treatment cycle to evaluate the safety and tolerability of DIT309.

Conditions

• Osteosarcoma
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	DIT309 cell injection	3+3 dose escalation design： Dose Level 1: 4.0×10\^6/kg CAR+ T cells；Dose Level 2: 1.0×10\^7/kg CAR+ T cells；Dose Level 3: 2.0×10\^7/kg CAR+ T cells.

Timeline

• Start date: 2025-08-20
• Primary completion: 2027-10-10
• Completion: 2027-10-10
• First posted: 2025-07-04
• Last updated: 2025-07-04

Locations

1 site across 1 country: China