BridgeMD
New treatment option for Kaposi Sarcoma
Official title Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV)
ClinicalTrials.gov ID: NCT07308886
What this study is testing
What is CYT107?
CYT107 is an investigational medicine, given as an once-weekly injection into a muscle, being studied as a potential treatment for kaposi sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join 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...
- Participants with stage T1 KS with visceral involvement must:
You likely can't join if
- -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). Note...
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to Chinese Hamster Ovary (CHO) cell products, chimeric or humanized...
- Participants must not have received chemotherapy, radiotherapy, or other KS directed therapy other than ART for HIV within 2 weeks before the...
- Participants must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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.
- -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). Note: Participants with hypothyroidism managed by supplemental levothyroxine...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.