Evidence map›Paper›PMID 39915263›Full record

ArticleJournal for immunotherapy of cancer2025

Phase I study of efineptakin alfa (NT-I7) for the treatment of Kaposi sarcoma.

Ramya Ramaswami, Angela Shaulov Kask, Leonard D'Amico, Manoj P Menon, Kathryn Lurain, Robert Yarchoan, Irene Ekwede, Paul Couey, Eli Burnham, Allysson Angeldekao and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04893018 (Phase 1 Study of NT-I7), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04893018 phase1terminatednot on this map

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

TypeinterventionalSponsorFred Hutchinson Cancer CenterRan2022 to 2023Enrolled8ConditionsAIDS-Related Kaposi Sarcoma, HIV Infection, Kaposi SarcomaArmsEfineptakin alfa
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Ramya RamaswamiHIV and AIDS Malignancy Branch, National Cancer Institute, Bethesda, Maryland, USA ramya.ramaswami@nih.gov.ORCID http://orcid.org/0000-0001-5709-4675
Angela Shaulov KaskCancer Immunotherapy Trials Network (CITN), Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Leonard D'AmicoCancer Immunotherapy Trials Network (CITN), Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Manoj P MenonFred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Kathryn LurainHIV and AIDS Malignancy Branch, National Cancer Institute, Bethesda, Maryland, USA.ORCID http://orcid.org/0000-0002-5794-7292
Robert YarchoanHIV and AIDS Malignancy Branch, National Cancer Institute, Bethesda, Maryland, USA.
Irene EkwedeHIV and AIDS Malignancy Branch, National Cancer Institute, Bethesda, Maryland, USA.
Paul CoueyDivision of Hematology and Medical Oncology, University of California San Francisco (UCSF) Helen Diller Comprehensive Cancer Center, San Francisco, California, USA.
Eli BurnhamHarborview Medical Center, Seattle, Washington, USA.
Allysson AngeldekaoHarborview Medical Center, Seattle, Washington, USA.
Byung Ha LeeNeoImmuneTech Inc, Rockville, Maryland, USA.
Judith C KaiserCancer Immunotherapy Trials Network (CITN), Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Martin CheeverCancer Immunotherapy Trials Network (CITN), Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Thomas S UldrickCancer Immunotherapy Trials Network (CITN), Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID http://orcid.org/0000-0001-6959-0924
Li-Lian KwokCytel (Shanghai) Co Ltd, Shanghai, China.
Anna WrightCancer Immunotherapy Trials Network (CITN), Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Steven P FlingCancer Immunotherapy Trials Network (CITN), Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Chia-Ching Jackie WangDivision of Hematology and Medical Oncology, University of California San Francisco (UCSF) Helen Diller Comprehensive Cancer Center, San Francisco, California, USA.

Funding

Cancer Immunotherapy Trials Network Central Operations and Statistical CenterUM1CA154967 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DAVIDSON, NANCY ELLEN · 2017 to 2022
$20.7M
Targeted therapies for Kaposi sarcoma and KSHV-multicentric Castleman diseaseZIABC011954 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI RAMASWAMI, RAMYA · 2020 to 2025
$3.8M
Intramural NIH HHS ZIA BC011954NCI NIH HHS UM1 CA154967
6 · The paper itself

Abstract

backgroundCD4

methodsIn this multicenter phase I study with a 3+3 dose escalation design, participants with KS with or without HIV received up to four intramuscular injections of IL-7 (NT-I7) every 9 weeks. The primary endpoint of the study was to evaluate safety over three escalating dose levels (DL) of NT-I7 (DL1:480 µg/kg, DL2: 960 µg/kg and DL3: 1200 µg/kg) and identify a maximum tolerated dose. Secondary endpoints included evaluation of antitumor activity per the modified AIDS Clinical Trials Group Criteria and assessment of the effect of NT-I7 on the kinetics of CD4

resultsEight cisgender male participants (five with HIV infection) were enrolled. Six participants were treated at DL1, and two were treated at DL2. The study was closed to accrual after enrolment of the second participant on DL2 due to termination of study funding. Four of the eight participants (three in DL1 and one in DL2) completed all four doses of the NT-I7. With regard to treatment-emergent adverse events (AEs), all participants had <grade 2 AEs, which included injection site reaction and alanine aminotransferase increase. Injection site reaction was a dose-limiting toxicity in one participant at DL1. The overall KS objective response rate to NT-I7 was 42.9% (95% CI 9.9%, 81.6%) and all three responders were PWH. Absolute lymphocyte counts, CD4

conclusionsPreliminary data demonstrate safety and activity of IL-7 in patients with KS and activity specifically among individuals HIV-associated KS. TRIAL REGISTRATION NUMBER: NCT04893018.

Indexed as

Interleukin-7Sarcoma, KaposiAdultAgedFemaleHIV InfectionsHumansMaleMaximum Tolerated DoseMiddle AgedInterleukin-7CytokineImmunotherapySkin CancerT cellVirology

Identifiers

PMID39915263
PMCPMC11804200

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.