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AIDS-Related Kaposi SarcomaPhase 1NCT04893018

NT-I7 for Kaposi Sarcoma in Patients With or Without HIV

A Phase 1 study testing Efineptakin alfa in people with AIDS-Related Kaposi Sarcoma and HIV Infection, run by Fred Hutchinson Cancer Center at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I trial studies the best dose and effects of NT-I7 in treating Kaposi sarcoma in patients with or without HIV. NT-I7 works by using a patient's immune system to fight cancer. It is made in a laboratory and is used to boost, direct, or restore the body's natural defenses against cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Efineptakin alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
3 sitesUnited States
Study dates
23 May 2022to 15 Dec 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed Kaposi sarcoma
  • Patients must have evaluable disease. Note: Kaposi sarcoma will be evaluated using a modified version (consistent with National Cancer Institute [NCI] studies) of the Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) Oncology Committee staging and response definitions for KS
  • No upper or lower limit on the number of prior therapies or stage of disease
  • HIV-positive patients must have been on effective anti-retroviral (ART) therapy for at least 3 months prior to enrollment, with persistent KS affecting quality of life due to either T1 disease or T0 disease with inadequate disease regression on ART alone
  • HIV-positive patients must have undetectable HIV viral loads =< 40 copies/mL measured using a Food and Drug Administration (FDA)-approved commercial assay with lower limit of detection between =< 20 copies/mL and =< 40 copies/mL
  • Patients with visceral involvement must:
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  • Meet other eligibility criteria
  • Have any/all associated tumor associated symptoms =< grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) criteria; and/or
  • Require no immediate intervention (e.g. mild oozing of oral KS not an exclusion criteria)
  • Patients must provide newly obtained core, punch, or excisional biopsy of a tumor lesion obtained up to 28 days prior to treatment initiation. An archival tumor sample obtained within 1 year of screening is allowed if pre treatment biopsy is deemed unsafe or technically not feasible
  • Patients must be >= 18 years of age on day of signing informed consent document. Because no dosing or adverse event data are currently available on the use of NT-I7 in patients < 18 years of age, children are excluded from this study but will be eligible for future pediatric trials
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Leukocytes >= 2,500/mcL
  • Absolute neutrophil count >= 1,000/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 9/dL
  • Total bilirubin =< 1.5 institutional upper limit of normal (ULN) OR < 3 x institutional ULN for Gilbert's syndrome or HIV protease inhibitors
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional ULN
  • Creatinine =< 2 x institutional ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 by Cockcroft-Gault. At the discretion of the treating physician, a 24-hour urine creatinine clearance could be obtained and utilized as the gold standard if creatinine clearance by Cockcroft-Gault is < 30 and prevents patient enrollment on the trial
  • Patients with chronic hepatitis B virus (HBV) infection must be on suppressive antiviral therapy
  • Patients with a history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load due to prior treatment or natural resolution
  • Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours before receiving the first dose of the study agent. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • The effects of NT-I7 on the developing human fetus are unknown. For this reason and because NT-I7 may have an adverse effect on pregnancy and poses risk to the human fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 90 days after completion of NT-I7 administration
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients who have had chemotherapy, radiotherapy or other KS directed therapy other than ART for HIV within 2 weeks before the initiation of study treatment
  • Patients who have not recovered from immune related adverse events due to prior therapy (i.e., have residual toxicities > grade 1) with the exception of hypothyroidism managed by supplemental levothyroxine
  • Patients who have received treatment with any other investigational agent within 4 weeks before initiation of study treatment
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Patients who have a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Patients who have received treatment with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or interleukin [IL]-2, pomalidomide, or immune checkpoint inhibitors) within 6 weeks before initiation of study treatment
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  • Patients who have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor [anti-TNF] agents) within 2 weeks before initiation of study treatment
  • Patients who have received acute, low dose, 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 patients with orthostatic hypotension or adrenocortical insufficiency is allowed
  • Patients who have a history or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis. Note: the following will NOT be exclusionary:
  • The presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody (ANA) titer or lupus anticoagulant) without associated symptoms
  • Clinical evidence of vitiligo or other forms of depigmenting illness
  • Mild autoimmunity not impacting the function of major organs (e.g., limited psoriasis)
  • Patients with uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina pectoris, cardiac arrhythmia, recent myocardial infarction (within the last 6 months). Patients with known history of treatment with cardiotoxic agents, including anthracyclines, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because the effects of NT-I7 on the developing human fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with NT-I7, breastfeeding should be discontinued if the mother is treated with NT-I7
  • Patients with a history of solid organ or allogeneic stem cell transplant
  • Patients with continuing KS regression on ART alone. Stable disease allowed
  • Patients with a prior or concurrent malignancy requiring active therapy
  • Patients with active tuberculosis
  • Patients who have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening X-Ray. History of radiation pneumonitis in the radiation field (fibrosis) is permitted

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

  • Zuckerberg San Francisco General Hospital

    San Francisco, California, 94110

  • Harborview Medical Center

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Phase 1 Study of NT-I7 (rhIL-7-hyFc) for the Treatment of Kaposi Sarcoma in Patients With or Without Infection With HIV

This phase I trial studies the best dose and effects of NT-I7 in treating Kaposi sarcoma in patients with or without HIV. NT-I7 works by using a patient's immune system to fight cancer. It is made in a laboratory and is used to boost, direct, or restore the body's natural defenses against cancer. NT-I7 may work better in treating Kaposi sarcoma.

Read the detailed description

OUTLINE: This is a dose-escalation study.

Patients receive efineptakin alfa intramuscularly (IM) on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up on day 30 (+/- 7 days) and then every 12 weeks for 12 months.

Being tested
Efineptakin alfa
Medical subject headings
AIDS-related Kaposi sarcoma, HIV Infections, Sarcoma, Kaposi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Efineptakin alfaBiological

    Also called 2026634-47-7, GX-I7, Hyleukin-7 (TM), Il-7 Hybrid Fc

    Given IM

Study groups in NCT04893018
Study groupRoleWhat they receive
Treatment (efineptakin alfa)ExperimentalPatients receive efineptakin alfa IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Efineptakin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events

    Measured by Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to 30 days after last dose of NT-I7, approximately 31 weeks total

Secondary outcomes (7)

  1. Objective Response Rate (ORR).

    Defined as the proportion of participants who achieved Complete Response (CR) or Partial Response (PR) according to modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group Criteria (ACTG) criteria.

    Measured: 12 months

  2. Duration of Response (DOR)

    Measured in participants who obtain a partial response or better and defined as time from the best response within the first 36 weeks of therapy until disease progression or censoring. Kaplan Meier survival estimates constructed for each of these survival endpoints with 95% confidence intervals (CIs), for up to 1 year following initiation of treatment in all participants.

    Measured: Up to 1 year

  3. Progression-free Survival (PFS)

    Defined as the time from administration of the first dose of NT-I7 until disease progression or death or censoring. Kaplan Meier survival estimates will be constructed for each of these survival endpoints with 95% CIs, for up to 1 year following initiation of treatment in all participants.

    Measured: Assessed up to 1 year

  4. Overall Survival (OS)

    From administration of the first dose of NT-I7 until death or censoring. Kaplan Meier survival estimates will be constructed for each of these survival endpoints with 95% CIs.

    Measured: Assessed up to 1 year following initiation of treatment

  5. Effect of NT-I7 on Kinetics of Absolute Lymphocyte Counts (ALC) in Blood

    For analysis of circulating lymphocytes, we will describe fold-change (median and range) in blood ALC. Fold change from baseline is defined as the ratio of the value at the visit to that at baseline.

    Measured: From pre-administration to each time point following first administration (1, 4, and 9 weeks)

  6. Effect of NT-I7 on Kinetics of CD4+ T Cells in Blood.

    Described by fold-change (median and range) in blood CD4+ T cells. Fold change from baseline is defined as the ratio of the value at the visit to that at baseline.

    Measured: From pre-administration to each time point following first administration (1, 4, and 9 weeks)

  7. Effect of NT-I7 on Kinetics of CD8+ T Cells in Blood.

    Described by fold-change (median and range) in blood CD8+ T cells. Fold change from baseline is defined as the ratio of the value at the visit to that at baseline.

    Measured: From pre-administration to each time point following first administration (1, 4, and 9 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2021
  2. Study start23 May 2022
  3. Primary completion15 Dec 2023
  4. Study completion15 Dec 2023

Why it stopped: Terminated due to end of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04893018
Sponsor's protocol ID
CITN-17
Other IDs
NCI-2021-01002, UM1CA154967
Status last verified
Apr 2024
First submitted
14 May 2021
Last updated
27 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ramaswami R, Kask AS, D'Amico L, Menon MP, Lurain K, Yarchoan R, Ekwede I, Couey P, Burnham E, Angeldekao A, Ha Lee B, Kaiser JC, Cheever M, Uldrick TS, Kwok LL, Wright A, Fling SP, Wang CJ. Phase I study of efineptakin alfa (NT-I7) for the treatment of Kaposi sarcoma. J Immunother Cancer. 2025 Feb 6;13(2):e010291. doi: 10.1136/jitc-2024-010291.

    PubMed 39915263

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Efineptakin alfa in people with AIDS-Related Kaposi Sarcoma and HIV Infection, run by Fred Hutchinson Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (time frame: Up to 30 days after last dose of NT-I7, approximately 31 weeks total). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04893018, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.

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