NCT03385486

Study of TBX-3400 in Patients With Stage III and IV Melanoma Resistant or Refractory to Immune Checkpoint Inhibitors

A Phase 1 Multi-Center Dose-Escalation Study of the Safety, Tolerability and Early Efficacy of TBX-3400 in Patients With Stage III and IV Melanoma Resistant or Refractory to Immune Checkpoint Inhibitors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Taiga Biotechnologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study of transfusion of TBX-3400 in patients with stage III and IV melanoma resistant or refractory to Immune Checkpoint Inhibitors. The patient's own blood cells are exposed to a protein that has been shown in the laboratory to result in anti-tumor activity. The study hypothesis is that TBX-3400 cells will enhance anti-tumor activity and improve the body's immune response.

Conditions

• Stage III Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	TBX-3400	Autologous transfusion

Timeline

• Start date: 2019-06-02
• Primary completion: 2023-02-01
• Completion: 2024-12-01
• First posted: 2017-12-28
• Last updated: 2022-05-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study