NCT00071071

Clinical Trial of HuMax-CD4, a New Drug to Treat Early 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 Refractory or Persistent Early Stage (IA-IIA) Cutaneous T-Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (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 early stage cutaneous T-cell lymphoma (CTCL). Almost all participants who are affected by CTCL have 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. During the trial, the response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated.

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 18 weeks.
DRUG	HuMax-CD4	HuMax-CD4 560 mg was administered as a SC infusion OD up to 18 weeks.

Timeline

• Start date: 2003-04-30
• Primary completion: 2004-05-05
• Completion: 2004-05-05
• First posted: 2003-10-15
• Last updated: 2023-05-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study