Lenalidomide + Cosibelimab for Cutaneous T-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I trial tests the safety, side effects and best dose of lenalidomide in combination with cosibelimab for the treatment of patients with mycosis fungoides or Sézary syndrome that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory).Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Immunotherapy with monoclonal antibodies, such as cosibelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide in combination with cosibelimab may be safe and tolerable in treating patients with relapsed or refractory mycosis fungoides or Sézary syndrome.
Who Is on the Research Team?
Christiane Querfeld
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with mycosis fungoides or Sézary syndrome (types of cutaneous T-cell lymphoma) whose disease has come back after treatment or hasn't responded to previous therapies.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Cosibelimab
- Lenalidomide
Trial Overview
The study is testing the safety and best dose of combining two drugs, lenalidomide and cosibelimab, in people with relapsed or hard-to-treat mycosis fungoides or Sézary syndrome. Participants will also have scans, skin biopsies, and lab tests.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive cosibelimab IV over 1 hour on day 1 and lenalidomide PO QD on days 1-14 of each cycle. Cycles repeat every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan with or without PET scan at baseline and may undergo CT scan with or without PET scan throughout the trial. Patients undergo skin biopsy and blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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