CYT107 for Kaposi Sarcoma in People with HIV
This study is testing a drug called CYT107 for people with Kaposi sarcoma (KS) who also have HIV and a weakened immune system. KS is a type of cancer that can affect the skin and other organs, often seen in people with HIV. CYT107 is a man-made protein that may help boost your immune system by increasing T cells, which are important for fighting infections and cancer. The goal is to see if CYT107 can shrink KS tumors. You may be able to join if you are 18 or older, have HIV-associated KS confirmed by a lab, and have at least five measurable skin lesions. The study aims to enroll 55 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. The study plans to enroll 55 participants.
- What's involved
- You will receive CYT107 injections weekly for up to 4 weeks. You will have physical exams and blood tests at screening, during treatment, and at follow-up visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your clinical benefit will be measured at various points up to 24 weeks after starting treatment.
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NCT07308886
Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV)
Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~55 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:CYT107
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical benefit
Measured over 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)
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Ramya M Ramaswami, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.6.0 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
platelets \>= 50,000/mcL
hemoglobin (hgb) \>= 8g/dL
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
CD4 T-cell count \<= 350/mcL
Participants must be willing to co-enroll to protocol 17C0174 "Molecular Characterization of Viral-associated Tumors, Tumors occurring in the Setting of HIV or other Immune Disorders and Castleman Disease"
Participants with chronic hepatitis B virus (HBV) infection are eligible if they are on suppressive antiviral therapy.
Participants with a hepatitis C virus (HCV) infection must have an undetectable HCV VL due to prior treatment or natural resolution.
Women of child-bearing potential (WOCBP) and men able to father a child must agree to use an effective method of contraception (hormonal, barrier, surgical sterilization, abstinence) at the study entry, for the duration of study therapy, and for up to 4 months
Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after the last dose of the study drug.
Participants must be able to understand and willing to sign a written informed consent document.
Exclusion
Participants who have not recovered from immune-related AEs due to prior therapy (i.e., have residual toxicities \> Grade 1 per CTCAE v.6.0).
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.
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.
History of allogeneic stem cell transplant and all other organ transplant.
Another prior or concurrent malignancy requiring active therapy
Active tuberculosis
Positive serum or urine beta-human chorionic gonadotropin (beta-hCG) test at screening.
Participants must not have received prohibited therapies within 4 weeks before initiation of study treatment
Severe uncontrolled intercurrent illness that would limit compliance with study requirements, as evaluated by history, physical exam, and chemistry panel.
What this trial measures
- Clinical benefitBaseline/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)
Percentage of participants with the best overall response of CR, CRR, or PR to therapy.