NCT06170294

MAGE-A4-directed TCR-T in the Treatment Amongst Subjects With Advanced Solid Tumors

A Single-arm, Open-label, Dose Exploratory Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Autologous Humanized MAGE-A4-directed T Cell Receptor Engineered T Cell (JWTCR001) in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A single-arm, open-label, dose exploratory study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell (TCR-T) in advanced solid tumors.

Detailed description

This study is a single-arm, open-label, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of T-cell receptor-engineered T cell (TCR-T) targeting melanoma-associated antigen-4 (MAGE-A4) and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumors with positive MAGE-A4 expression and refractory to prior standard systemic treatments.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	TCR-MAGE-A4 T-Cells	* Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses * MAGE-A4-directed T cell receptor-engineered T Cells

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-12-31
• Completion: 2028-12-31
• First posted: 2023-12-14
• Last updated: 2023-12-14

Locations

1 site across 1 country: China