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

May 16, 2023 updated by: Genmab

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-5152
        • Stanford University Med. Ctr., Dept. of Dermatology
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas, M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Medical diagnosis of CTCL, and positivity for the CD4 receptor.
  • Early stage CTCL
  • Have received at least two prior therapies with inadequate effect, including phototherapy and/or electron beam, and/or chemotherapy.
  • Histopathological evidence of large cell transformation or poorly differentiated tumors or prior treatment with anti-CD4 monoclonal antibodies excluded participants from inclusion in the study.

Exclusion Criteria

  • Certain rare types of CTCL.
  • Previous treatment with other anti-CD4 medications.
  • More than two previous treatments with systemic chemotherapy.
  • Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial.
  • Some types of steroid treatments less than two weeks before entering the trial.
  • Prolonged exposure to sunlight or UV light during the trial.
  • Other cancer diseases, except certain skin cancers or cervix cancer.
  • Chronic infectious disease requiring medication.
  • Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases.
  • Pregnant or breast-feeding women.
  • Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial.
  • If you are participating in another trial with a different new drug 4 weeks before you enter this trial.

Note: Other protocol defined Inclusion and Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HuMax-CD4 280 milligrams (mg)
Drug: HuMax-CD4
HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 18 weeks.
Other Names:
  • Zanolimumab
Drug: HuMax-CD4
HuMax-CD4 560 mg was administered as a SC infusion OD up to 18 weeks.
Other Names:
  • Zanolimumab
Experimental: HuMax-CD4 560 mg
Drug: HuMax-CD4
HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 18 weeks.
Other Names:
  • Zanolimumab
Drug: HuMax-CD4
HuMax-CD4 560 mg was administered as a SC infusion OD up to 18 weeks.
Other Names:
  • Zanolimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale
Time Frame: Up to 20 weeks
Up to 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Time Frame: Up to Week 20
Up to Week 20
Number of Participants with Adverse Events (AEs)
Time Frame: From Baseline (Day 0) up to end of study (Week 20)
From Baseline (Day 0) up to end of study (Week 20)
Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response at Weeks 2, 4 and 12
Time Frame: At Weeks 2, 4 and 12
At Weeks 2, 4 and 12
Percentage of Participants With Change from Baseline in Participant's Assessment of Pruritus Scale
Time Frame: Baseline, up to Week 20
The participants were assessed pruritus on a 5-point scale from 0-4: 0. No complaint of itching on lesion; 1. Mild: Occasional transient itching on lesion; 2. Moderate: Frequent itching, every 1-3 hours; reflex scratching; 3. Severe: Compelling itching; interrupts daily activities; must be scratched; 4. Very severe: Unrelieved itching: prevents routine activities; awakens patient from sleep.
Baseline, up to Week 20
Time to Response
Time Frame: From first dose to achieving a response (up to approximately 11 weeks)
From first dose to achieving a response (up to approximately 11 weeks)
Response Duration
Time Frame: From achieving first response to last response/until relapse (up to approximately 92 weeks)
From achieving first response to last response/until relapse (up to approximately 92 weeks)
Time to Disease Progression
Time Frame: From first dose until disease progressed (Up to 20 weeks)
From first dose until disease progressed (Up to 20 weeks)
Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA)
Time Frame: Baseline up to Week 20
Baseline up to Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2003

Primary Completion (Actual)

May 5, 2004

Study Completion

May 5, 2004

Study Registration Dates

First Submitted

October 10, 2003

First Submitted That Met QC Criteria

October 14, 2003

First Posted (Estimate)

October 15, 2003

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hx-CD4-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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