Clinical trial · Interventional
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): New sponsor, other treatments available
Summary
Brief summary (as posted)
The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
| Sezary Syndrome | Sezary Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HuMax-CD4 (zanolimumab) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zanolimumab
- interventionNames
- Drug: HuMax-CD4 (zanolimumab)
Primary outcomes (1)
- measure
- PGA Score
- timeFrame
- Duration of Study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry * Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof). * Signed informed consent Exclusion Criteria: * Prior treatment with Total Skin Electron Beam (TSEB) therapy within six months * Prior treatment with Campath (alemtuzumab) * Prior treatment with more than three regimens of single agent chemotherapy * Prior treatment with pentostatin within 6 months * Treatment within 4 weeks prior to visit 2 with topical Targretin®, skin directed therapies or systemic anticancer therapies, such as, but not limited to: Targretin® , UV-light therapy, local Electron Beam Therapy (EBT), extracorporal photo chemotherapy, methotrexate, bleomycin, cyclophosphamide, combination chemotherapy, oral retinoids, systemic glucocorticosteroids , carmustine, nitrogen mustard, systemic vitamin A or etretinate * Treatment with topical glucocorticosteroids within 2 weeks prior to visit 2 * Unwillingness or inability to avoid prolonged exposure to the sun or UV light sufficient to produce a mild erythema or thought by the investigator to likely modify the patient's disease * Concurrent or previous malignancies within the past five years except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell skin carcinoma * Significant concurrent, uncontrolled, or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease * Known or suspected positive serology for HIV * Known or suspected positive serology for hepatitis B or C * Patients who are currently participating in any other trials or having received treatment with any experimental agent within 4 weeks prior to visit 1 (screening) * Prior treatment with anti-CD4 monoclonal antibodies * Breast feeding women or women with a positive pregnancy test at Visit 1 * Women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period
References
Publications (0)
Data not yet available