Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV)
Recruiting now · Phase 2
Conditions studied: Kaposi Sarcoma
In brief
Background: Kaposi sarcoma (KS) is a cancer that causes abnormal tissue to grow in the skin, lymph nodes, and other organs. KS is caused by a virus known as Kaposi sarcoma herpesvirus. People infected with human immunodeficiency virus (HIV) account for 80% of KS cases in the United States. Having HIV can weaken the immune system and this can lead to KS. Weaker immune systems may be measured by low T cells (a type of immune cell). CYT107 is a human protein, made in a laboratory, that may help boost immunity, specifically by increasing T cells, in people with HIV-associated KS. Objective: To see if CYT107 can shrink KS tumors. Eligibility: People aged 18 years and older with HIV-associated KS. Design: Participants will be screened. They will have a physical exam with blood tests. Their skin lesions will be measured. They will have an x-ray of their lungs. Their ability to perform everyday tasks will be reviewed. A sample of lesion tissue (biopsy) may be collected from the skin. CYT107 is injected into the muscle of the arm, buttocks, or lower thigh once a week for up to 4 weeks. Participants will receive the shots at the clinic. Blood and other tests will be repeated at each visit. KS lesions will be measured and photographed on the 1st and 4th visits. Participants who improved after the first 4 weeks may have another 4-week treatment within a year. Follow-up visits will continue for 3 years.
Key facts
- Study ID
- NCT07308886
- Run by
- National Cancer Institute (NCI)
- People needed
- 55
- Starts
- 2026-04-08
- Expected to finish
- 2037-01-31
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Participants who have not recovered from immune-related AEs due to prior therapy (i.e., have residual toxicities > Grade 1 per CTCAE v.6.0).
- Note: Participants with hypothyroidism managed by supplemental levothyroxine are eligible.
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to Chinese Hamster Ovary (CHO) cell products, chimeric or humanized antibodies or fusion proteins.
- Participants must not have received chemotherapy, radiotherapy, or other KS directed therapy other than ART for HIV within 2 weeks before the initiation of study drug.
- Participants must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) or systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or IL-2, pomalidomide, or immune checkpoint inhibitors) within 2 weeks before initiation of study treatment.
- Note: Participants who have received acute, low dose of systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled. The use of inhaled corticosteroids, and mineralocorticoids (e.g., fludrocortisone) for participants with orthostatic hypotension or adrenocortical insufficiency is allowed.
- History or risk of autoimmune disease, except for:
- the presence of laboratory evidence of autoimmune disease (e.g., history of positive antinuclear antibody [ANA] titer or lupus anticoagulant) without associated symptoms,
- clinical evidence of vitiligo or other forms of depigmenting illness; and/or,
- mild autoimmunity not impacting the function of major organs (e.g., limited psoriasis).
- History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (e.g., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest x-ray.
- Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- History of allogeneic stem cell transplant and all other organ transplant.
- Another prior or concurrent malignancy requiring active therapy
- Active tuberculosis
- Positive serum or urine beta-human chorionic gonadotropin (beta-hCG) test at screening.
- Participants must not have received prohibited therapies within 4 weeks before initiation of study treatment
- Severe uncontrolled intercurrent illness that would limit compliance with study requirements, as evaluated by history, physical exam, and chemistry panel.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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