Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV)

NCT07308886 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 10002361002361-C
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Kaposi Sarcoma

Keywords

human herpesvirus 8; KS-associated herpes virus; HIV; Interleukin-7; Lymphoproliferative Disorder

Outcome Measures

Primary Outcomes (1)

• Clinical benefit

  Percentage of participants with the best overall response of CR, CRR, or PR to therapy.

  Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (week 24 )

Secondary Outcomes (5)

• Safety of CYT107

  Prior to each cycle, at EOT (week 8), and at safety visits (weeks 12 and 16)

• Time of duration of response

  Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (up to 3 years post-treatment)

• Time of progression free survival

  Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (up to 3 years post-treatment)

• Proportion of participants requiring a second course of CYT107.

  ongoing

• Clinical benefit of a second course of CYT107

  Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (week 24 )

Study Arms (1)

Arm 1

EXPERIMENTAL

Treatment with CYT107

Drug: CYT107

Interventions

CYT107 DRUG

CYT107 is administered by IM injections at 20 mcg/kg every week for up to 4 weeks/4 doses

Arm 1

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed KS by NCI Laboratory of Pathology (LP), with or without any prior systemic KS treatment
• Participants with HIV infection
• Age \>= 18 years
• All participants should have at least five (5) measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion.
• Participants with stage T1 KS with visceral involvement must:
• have any/all associated tumor associated symptoms \<= Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 criteria and/or,
• require no immediate intervention (e.g., mild oozing of oral KS is allowed).
• Participants did not receive prior systemic therapy for KS or received prior systemic therapy and currently are either plateau in response, relapsed disease, progressive disease (PD), or inadequate response to treatment. Note: Previous local therapy or radiation is not considered systemic therapy.
• Participants must:
• have been on effective ART therapy for at least 2 months prior to the study drug initiation and
• have HIV VL \<= 100 copies/mL and
• have persistent KS, affecting quality of life due to either T1 or T0 disease with inadequate disease regression on ART alone.
• ECOG PS \<=3
• Adequate organ and marrow function as defined below:
• absolute neutrophil count (ANC) \>= 500/mcL

You may not qualify if:

• Participants who have not recovered from immune-related AEs due to prior therapy (i.e., have residual toxicities \> Grade 1 per CTCAE v.5.0).
• Note: Participants with hypothyroidism managed by supplemental levothyroxine are eligible.
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to Chinese Hamster Ovary (CHO) cell products, chimeric or humanized antibodies or fusion proteins.
• Participants must not have received chemotherapy, radiotherapy, or other KS directed therapy other than ART for HIV within 2 weeks before the initiation of study drug.
• Participants must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) or 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.
• Note: Participants who have received acute, low dose of systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled. The use of inhaled corticosteroids, and mineralocorticoids (e.g., fludrocortisone) for participants with orthostatic hypotension or adrenocortical insufficiency is allowed.
• History or risk of autoimmune disease, except for:
• the presence of laboratory evidence of autoimmune disease (e.g., history of positive antinuclear antibody \[ANA\] titer or lupus anticoagulant) without associated symptoms,
• clinical evidence of vitiligo or other forms of depigmenting illness; and/or,
• mild autoimmunity not impacting the function of major organs (e.g., limited psoriasis).
• History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (e.g., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest x-ray.
• Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• History of allogeneic stem cell transplant and all other organ transplant.
• Another prior or concurrent malignancy requiring active therapy
• Active tuberculosis

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Sarcoma, Kaposi; Lymphoproliferative Disorders

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ramya M Ramaswami, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NCI Referral Office

CONTACT

(888) 624-1937; ncimo_referrals@mail.nih.gov

Ramya M Ramaswami, M.D.

CONTACT

(240) 506-1088; ramya.ramaswami@nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: December 30, 2025
• Study Start: April 8, 2026
• Primary Completion (Estimated): January 31, 2036
• Study Completion (Estimated): January 31, 2037
• Last Updated: April 13, 2026

Record last verified: 2026-03-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available as soon as possible or at the time of associated publication. Data not published in a manuscript will be shared via public source once the data set completes QC.
• Access Criteria: Clinical data will be made available upon request and with the permission of the study PI.

Locations

US (1)