RecruitingPhase 2NCT07308886

Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV)

Phase II Study of Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-response (REGIMEN-KS HIV)


Sponsor

National Cancer Institute (NCI)

Enrollment

55 participants

Start Date

Apr 8, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called CYT107 (recombinant human interleukin-7) — a protein that boosts immune cell production — for people with HIV who have Kaposi sarcoma (a type of cancer that causes lesions on the skin and in organs) and whose immune systems have not recovered fully despite HIV treatment. **You may be eligible if...** - You are 18 or older and have HIV infection - You have histologically confirmed Kaposi sarcoma (KS) - You have at least 5 measurable cutaneous (skin) KS lesions without prior local treatment that would prevent response assessment - You meet specific CD4 count and HIV viral load criteria showing immune non-response **You may NOT be eligible if...** - You have very advanced or symptomatic visceral (internal organ) KS beyond grade 2 - You have had prior therapies that conflict with study requirements - Your organ function does not meet minimum thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCYT107

CYT107 is administered by IM injections at 20 mcg/kg every week for up to 4 weeks/4 doses


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT07308886


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