NCT03893019

MB-CART20.1 Melanoma

Multicenter Phase I Trial of MB-CART20.1 for the Treatment of Patients With Metastatic Melanoma

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Miltenyi Biomedicine GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase l multi-centric, single arm, prospective, open, dose-escalation study in patients with unresectable stage III oder IV melanoma. The trial will include 15 adult patients. The trial is a classic 3+3 design with 1 Log dose increments and maximum 3 dose levels of the intravenously administered MB-CART20.1.

Detailed description

This Phase I trial will be the first trial with CD20 CAR transduced T cells in Europe targeting melanoma. The rationale for the trial is based on the finding that melanoma cancer sustaining cells express CD20 and that targeting CD20+ cells in preclinical model has a strong antitumor effect.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	MB-CART20.1	MB-CART20.1 consists of autologous CD20 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells targeting CD20.positive tumor cells

Timeline

• Start date: 2019-03-08
• Primary completion: 2023-01-30
• Completion: 2023-01-30
• First posted: 2019-03-27
• Last updated: 2024-05-16

Locations

1 site across 1 country: Germany