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

NCT07052383 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-05

No results posted yet for this study

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

Interventions

BIOLOGICAL

DIT309 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.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Tcelltech Inc.

    lead INDUSTRY

Principal Investigators

  • Gangxiong Huang, MD · Tcelltech Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-06
Primary Completion
2027-10-10
Completion
2027-10-10

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07052383 on ClinicalTrials.gov