NCT00071084

Clinical Trial of HuMax-CD4, a New Drug to Treat Advanced Stage T-Cell Lymphoma in the Skin.

An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Advanced Stage (IIA-IVB) Cutaneous T-cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine the effect of HuMax-CD4, as a treatment for advanced stage (late stage) cutaneous T-cell lymphoma (CTCL). Almost all participants who are affected by late stage CTCL have many cancerous cells which bear a receptor called CD4. HuMax-CD4 is an investigational drug directed against this receptor. There is no placebo in this trial; all participants will be treated with HuMax-CD4. The response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated during this trial.

Conditions

• Cutaneous T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	HuMax-CD4	HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 16 weeks.
DRUG	HuMax-CD4	HuMax-CD4 980 mg was administered as a SC infusion OD up to 16 weeks.

Timeline

• Start date: 2003-05-27
• Primary completion: 2004-06-29
• Completion: 2004-06-29
• First posted: 2003-10-15
• Last updated: 2023-04-28

Locations

5 sites across 4 countries: United States, Germany, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study