Clinical trial · Interventional
Immunization Against Tumor Cells in Sezary Syndrome
Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells
- 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)
This research is being done to look at the safety and value of a vaccine for a cancer found in the blood and skin known as Cutaneous T-cell lymphoma (CTCL) and Sezary Syndrome. In the laboratory, researches found that special white blood cells, called dendritic cells (DCs), are able to stimulate the immune system (groups of cells that protect the body from germs and diseases) in a way that helps your body fight cancer. Autologous (from your own body) DCs will be prepared (mixed together) in the laboratory with your cancer cell (Sezary cells) to allow your DCs to pick up parts of your Sezary cells to make the vaccine for you.
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 |
|---|---|---|---|
| Cutaneous T-cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Sezary Syndrome | Sezary Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Dendritic Cell Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Clinical response (clearance of skin lesions, clinical and radiographic improvement in lymphadenopathy)
Secondary outcomes (4)
- measure
- Biological response
- measure
- Survival
- measure
- Activities of daily living
- measure
- Quality of Life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of Sezary syndrome * Must be willing to discontinue concomitant medications for CTCL, including: \*Oral steroids above 10 mg - 30 day washout, unless subject has Addison's Disease or adrenal insufficiency, \*PUVA or UVB - 2 week washout, sunbathing, tanning beds, etc. and for the duration of the study, \*Electron Beam - for the duration of the study, \*Chemotherapeutic agents - 30 day washout, \*Bexarotene capsules or other oral biologics - 3 week washout, \*Topical nitrogen mustard - 2 week washout, \*Extracorporeal photopheresis - 4 week washout and for the duration of the study. * Must be at least 18 years of age and must be able to understand the written informed consent. * Subjects must have no evidence of active infection. Subjects with active infections (whether or not they require antibiotic therapy) may be eligible for continuation of therapy after complete resolution of the infection. Subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatment. Exclusion Criteria: * Subjects with autoimmune disease, HIV, and/or hepatitis * Subjects who are pregnant or lactating
References
Publications (0)
Data not yet available