Study on CYT107 for Treating Kaposi Sarcoma in People with HIV and Low Immune Response

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT07308886

Provider View

This clinical trial is testing a new treatment called CYT107, which is a lab-made protein that may help boost the immune system in people with HIV-related Kaposi Sarcoma (KS). The study aims to see if CYT107 can help shrink KS tumors.

Patient Parameters

Program Overview

Kaposi Sarcoma (KS) is a type of cancer that causes abnormal tissue growth in the skin and other organs, often linked to a virus. People with HIV are more likely to develop KS because HIV weakens the immune system. This study is testing CYT107, a protein made in the lab, to see if it can help strengthen the immune system by increasing T cells, which are important for fighting infections and cancer. Participants will receive CYT107 injections once a week for up to 4 weeks, and their KS lesions will be measured to see if they improve. Those who show improvement may receive another round of treatment within a year. Follow-up visits will continue for 3 years to monitor their health and the treatment's effects.

Description

Kaposi Sarcoma (KS) is a cancer linked to a virus and is more common in people with HIV. This study is testing CYT107, a lab-made protein that may help boost the immune system by increasing T cells, which are crucial for fighting infections and cancer. The study aims to see if CYT107 can shrink KS tumors in people with HIV who have low T cell counts.

Participants will receive CYT107 injections into the muscle once a week for up to 4 weeks. The injections will be given at the clinic, and participants will have regular blood tests and measurements of their KS lesions. If participants show improvement after the first 4 weeks, they may receive another 4-week treatment within a year.

The study will follow participants for 3 years to monitor their health and the effects of the treatment. Participants must be 18 years or older, have HIV-related KS, and have at least five measurable KS lesions. They must also have low T cell counts and be on effective HIV treatment. Women of childbearing potential and men able to father a child must agree to use contraception during the study and for 4 months after the last dose.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a confirmed diagnosis of Kaposi Sarcoma (KS) and be living with HIV.
  • Have at least five measurable KS skin lesions.
  • Have a low T cell count (350 cells/mcL or less).
  • Be on effective antiretroviral therapy (ART) for at least 2 months before starting the study.
  • Have a stable HIV viral load (100 copies/mL or less).
  • Have adequate organ and blood cell function.
  • Be willing to sign a consent form and follow study procedures.
  • Women of childbearing potential and men able to father a child must agree to use effective contraception during the study and for 4 months after the last dose.

Exclusion Criteria

  • Have not recovered from side effects of previous treatments.
  • Have severe allergies to certain lab-made proteins.
  • Have received chemotherapy, radiotherapy, or other KS treatments within 2 weeks before starting the study.
  • Have used certain immune system-affecting medications within 2 weeks before starting the study.
  • Have a history of autoimmune diseases, except for mild cases that do not affect major organs.
  • Have lung diseases like pneumonitis or fibrosis.
  • Have had a stem cell or organ transplant.
  • Have another active cancer requiring treatment.
  • Have active tuberculosis.
  • Have a positive pregnancy test at screening.
  • Have severe uncontrolled illnesses that would affect study participation.

Locations

FACILITYZIPCITYSTATE
National Institutes of Health Clinical Center20892BethesdaMaryland

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