NCT07108140

Engineered T-cell Therapy for Patients With ALPP-Positive Advanced Solid Tumors

A Single-Arm, Single-Center, Open-Label Pilot Study of Patients With ALPP-Positive Advanced Solid Tumors

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: TCRCure Biopharma Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of ALPP CAR-T cells in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.

Detailed description

This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of ALPP CAR-T cell therapy in patients with recurrent or metastatic solid tumors. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) ALPP CAR-T cell infusion, and (5) post-infusion follow-up.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Anti ALPP CAR-T cells treatment	anti ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.

Timeline

• Start date: 2025-05-20
• Primary completion: 2025-12-31
• Completion: 2026-01-16
• First posted: 2025-08-06
• Last updated: 2026-01-22

Locations

1 site across 1 country: China