Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T-Cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HuMax-CD4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HuMax-CD4 280 milligrams (mg)
- interventionNames
- Drug: HuMax-CD4
- type
- EXPERIMENTAL
- label
- HuMax-CD4 560 mg
- interventionNames
- Drug: HuMax-CD4
Primary outcomes (1)
- measure
- Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale
- timeFrame
- Up to 20 weeks
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available