Background:
* Kaposi sarcoma (KS) is an angioproliferative tumor associated with KS-associated herpes virus (KSHV), also known as human herpesvirus 8 or (HHV-8) infection.
* Human immunodeficiency virus (HIV) infection-related KS accounts for greater than 80% of KS in the United States.
* Survival rates from HIV-related KS are poorer than classic KS, despite improving substantially with the introduction of antiretroviral therapy (ART).
* KS oncogenesis is associated with loss of T-cell mediated control of KSHV, the viral cause of KS.
* While treatment of persons with HIV (PWH) with ART can improve T-cell counts and immunity, their T-cell counts often do not return to normal and they are often left with residual immunodeficiency.
* There are a group of patients who have well controlled HIV but continue to have low CD4 T-cell counts (\<=350 cells/mcL) who are termed immune non-responders . This group possess a high rate of KS persistence, and chemotherapy can often contribute to
lymphopenia.
* The cytokine interleukin-7 (IL-7) plays an important role in T-cell development and proliferation and regulates T-cell homeostasis throughout life.
* IL-7 administration is very potent at producing new T cells such as na(SqrRoot) ve T cells and recent thymic emigrants.
* Administration of short acting recombinant human IL-7 was well-tolerated and has resulted in a dose-dependent increase in peripheral T cells and broadening of T-cell receptor (TCR) diversity.
Objective:
-To assess the overall response rate (ORR) of CYT107 defined as the best response (complete response \[CR\], clinical complete response \[CRR\], partial response \[PR\]) within 24 weeks in the first course of treatment, using the modified AIDS Clinical Trial Group
(ACTG) KS response criteria in immune non-response participants with HIV-associated KS who had prior systemic KS therapy or who are KS therapy naive
Eligibility:
* Age \>=18 years
* Histologically confirmed diagnosis of KS in people with HIV.
* All participants should have at least five (5) measurable cutaneous KS lesions.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<=3
* CD4 T cell count \<=350 cells/mcL
* This is an open label, nonrandomized Phase II study assessing the safety and activity of CYT107 in participants with HIV-associated KS.
* Participants will be enrolled in two cohorts based on prior exposure to KS therapy.
* A safety run-in will be conducted for the first 12 participants with no more than three participants treated simultaneously.
* Participants will receive CYT107 at 20 mcg/kg by intramuscular (IM) injections every week for up to 4 weeks/4 doses.
* Participants who have an increase in CD4 T-cell count following administration of CYT107 and evidence of KS response per ACTG criteria but subsequently experience a decrease in CD4 T-cell count (\>=100 cells/mcL) with associated deterioration in KS, or have
had prior systemic KS therapy and first course resulted in SD only, may be eligible to receive a second course of CYT107 administration (for up to 4 weeks/4 doses).
-Up to 29 evaluable participants will be enrolled.
