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

Sponsor
Tcelltech Inc.
Study ID
NCT07052383
Phase
PHASE1
Status
Recruiting
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Conditions

  • Osteosarcoma
  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
8 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 4, 2025
Start date
Nov 6, 2025
Status verified
Mar 2026
Primary completion
Oct 10, 2027
Completion
Oct 10, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohort
    DIT309 were administered via intravenous reinfusion on Days 1 in a 28-day treatment cycle.

Primary Outcome Measure

Safety：Incidence of Dose Limiting Toxicity (DLT) [ Time Frame: 28 days after the first DIT309 infusion. ]

Central Contacts

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