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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 (Sep 2026). This Phase 2 trial studies CYT107 for kaposi sarcoma.

Phase 2RecruitingNational Cancer Institute (NCI)NCT07308886Data as of Sep 2026

Treatment: CYT107Background: 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.

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Extracted eligibility criteria

Treatments studied

Other

CYT107

Cancer type

Sarcoma

Tumor Agnostic

Biomarker criteria

Required: HIV1 infection

Performance status

ECOG 0–3(Limited self-care)

Demographics

Ages ≤ 120

Prior therapy

Must have received: antiretroviral therapy

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

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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Frequently asked questions

Is NCT07308886 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received antiretroviral therapy.

Does this trial require HIV1?

Yes, HIV1 infection is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 120 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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Related pages

Sarcoma trials