OncoMatch/Clinical Trials/NCT07308886
Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV)
Is NCT07308886 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies CYT107 for kaposi sarcoma.
Treatment: CYT107 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: antiretroviral therapy
have been on effective ART therapy for at least 2 months prior to the study drug initiation
Cannot have received: systemic immunosuppressive medications (prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF agents)
Exception: acute, low dose (e.g., one-time dose of dexamethasone for nausea), inhaled corticosteroids, mineralocorticoids for orthostatic hypotension or adrenocortical insufficiency
systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within 2 weeks before initiation of study treatment
Cannot have received: systemic immunostimulatory agents (interferon-alpha, IL-2, pomalidomide, immune checkpoint inhibitors)
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
Cannot have received: chemotherapy
Participants must not have received chemotherapy...within 2 weeks before the initiation of study drug
Cannot have received: radiotherapy
Participants must not have received...radiotherapy...within 2 weeks before the initiation of study drug
Cannot have received: KS directed therapy other than ART
Participants must not have received...other KS directed therapy other than ART for HIV within 2 weeks before the initiation of study drug
Cannot have received: prohibited therapies
Participants must not have received prohibited therapies within 4 weeks before initiation of study treatment
Lab requirements
Blood counts
absolute neutrophil count (ANC) >= 500/mcL; platelets >= 50,000/mcL; hemoglobin (hgb) >= 8g/dL
Liver function
total bilirubin <= 1.5 institutional upper limit of normal (iULN) or <3 x iULN for Gilbert's syndrome or HIV protease inhibitors; AST <= 2.5 x iULN; ALT <= 2.5 x iULN
Adequate organ and marrow function as defined below: absolute neutrophil count (ANC) >= 500/mcL; platelets >= 50,000/mcL; hemoglobin (hgb) >= 8g/dL; total bilirubin <= 1.5 institutional upper limit of normal (iULN) or <3 x iULN for Gilbert's syndrome or HIV protease inhibitors; AST <= 2.5 x iULN; ALT <= 2.5 x iULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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