NCT07231081

Phase I Study of TX103 CAR-T Cells in Participants With Advanced Solid Tumors

An Open-label, Single-arm, Phase I Clinical Trial to Evaluate the Safety and Efficacy of TX103 CAR-T Cells in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Tcelltech Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, Phase I study to evaluate the safety, tolerability, and antitumor activity of TX103 CAR-T cells in subjects with TX103-positive advanced solid tumors. The study also aims to explore the maximum tolerated dose (MTD) and determine the recommended Phase II dose (RP2D) of TX103 CAR-T cell therapy.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103	TX103 CAR-T cells are autologous T cells genetically engineered to express a chimeric antigen receptor (CAR) targeting TX103-positive tumor cells. This therapy is designed to recognize and kill TX103-expressing malignant cells. TX103 CAR-T cells are administered either via intravenous (IV) infusion or intraperitoneal (IP) infusion, depending on the cohort. For dose-escalation cohorts (Phase Ia), a standard 3+3 design is used: 1. IV dose-escalation cohort: planned doses range from 1.0 × 10⁸ to 2.0 × 10⁹ CAR-T cells. 2. IP dose-escalation cohort: initiated sequentially after the IV cohort; starting dose is based on the safe and potentially efficacious dose from IV cohort, with planned escalation up to 4.0 × 10⁹ CAR-T cells. The Phase Ib expansion cohort administers TX103 CAR-T at the dose determined to be safe and potentially efficacious in Phase Ia, focusing on tumor types that showed preliminary signs of antitumor activity and meet clinical needs. TX103 CAR-T therapy is distinct fro

Timeline

• Start date: 2025-10-16
• Primary completion: 2027-12-20
• Completion: 2027-12-20
• First posted: 2025-11-17
• Last updated: 2025-11-17

Locations

2 sites across 1 country: China