Actively Recruiting
Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV)
Led by National Cancer Institute (NCI) · Updated on 2026-05-08
55
Participants Needed
1
Research Sites
564 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed Kaposi sarcoma (KS) diagnosis
- HIV infection
- Age 18 years or older
- At least five measurable skin KS lesions without prior local radiation, surgery, or intralesional cytotoxic therapy on those lesions
- For stage T1 KS with visceral involvement: tumor symptoms Grade 2 or less and no immediate intervention needed
- Either no prior systemic KS therapy or prior systemic therapy with plateau, relapse, progression, or inadequate response
- On effective antiretroviral therapy (ART) for at least 2 months before study start
- HIV viral load 100 copies/mL or less
- Persistent KS affecting quality of life despite ART
- Eastern Cooperative Oncology Group performance status of 3 or less
- Adequate organ and marrow function (ANC 500/mcL or higher, platelets 50,000/mcL or higher, hemoglobin 8 g/dL or higher, bilirubin and liver enzymes within specified limits)
- CD4 T-cell count 350/mcL or less
- Willingness to co-enroll in related molecular characterization protocol
- Chronic hepatitis B patients allowed if on antiviral therapy
- Hepatitis C patients allowed if viral load undetectable
- Women and men able to father children must agree to use effective contraception during and for 4 months after treatment
- Nursing participants must agree to stop nursing from start of treatment through 4 months after last dose
- Able and willing to provide informed consent
You will not qualify if you...
- Unresolved immune-related adverse events from prior therapy above Grade 1, except treated hypothyroidism
- History of severe allergic or hypersensitivity reactions to certain lab products or antibodies
- Received chemotherapy, radiotherapy, or KS treatment other than ART within 2 weeks before starting study drug
- Received systemic immunosuppressive or immunostimulatory drugs within 2 weeks before study start, except low-dose acute steroids or allowed inhaled corticosteroids
- History or risk of autoimmune diseases except mild or laboratory-only evidence without symptoms
- History of specific lung diseases or active pneumonitis on screening chest X-ray, except radiation fibrosis
- History of stem cell or organ transplant
- Another active cancer requiring treatment
- Active tuberculosis
- Positive pregnancy test at screening
- Received prohibited therapies within 4 weeks before study start
- Severe uncontrolled illness that could affect study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI Referral Office
CONTACT
R
Ramya M Ramaswami, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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