Evidence map›Paper›PMID 36399701›Full record

Trial reportBlood2023

A phase 2 study of interleukin-22 and systemic corticosteroids as initial treatment for acute GVHD of the lower GI tract.

Doris M Ponce, Amin M Alousi, Ryotaro Nakamura, John Slingerland, Marco Calafiore, Karamjeet S Sandhu, Juliet N Barker, Sean Devlin, Jinru Shia, Sergio Giralt and 15 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02406651 (A Phase IIa Study of Recombinant Human Interleukin-22 IgG2-Fc), which is not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
5.9field-weighted citation impact, top 3% of its field
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.

NCT02406651 phase1 / phase2completednot on this map

A Phase IIa Study of Recombinant Human Interleukin-22 IgG2-Fc (F 652) in Combination With Systemic Corticosteroids for the Treatment of Newly Diagnosed Grade II-IV Lower Gastrointestinal Acute Graft-versus-Host Disease (aGVHD) in Hematopoietic Stem Cell Transplantation Recipients (HSCT)

TypeinterventionalSponsorEVIVE BiotechnologyRan2016 to 2020Enrolled30ConditionsAcute Graft vs Host DiseaseArmsRecombinant Human Interleukin-22 IgG2-Fc (F-652), Systemic Corticosteroids
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 41 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. A modular platform for Sterically Masked Activated Cytokines (SMACks).Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Novel treatment of acute and acute-on-chronic liver failure: Interleukin-22.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 4 institutions in 2 countries.

Doris M PonceDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-9422-5766
Amin M AlousiDepartment of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX.
Ryotaro NakamuraHematologic Malignancies and Stem Cell Transplantation Institute, City of Hope National Medical Center, Duarte, CA.ORCID 0000-0002-9082-0680
John SlingerlandDepartment of Immunology, Sloan Kettering Institute, Memorial Sloan Kettering Cancer Center, New York, NY.
Marco CalafioreDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Karamjeet S SandhuHematologic Malignancies and Stem Cell Transplantation Institute, City of Hope National Medical Center, Duarte, CA.
Juliet N BarkerDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Sean DevlinDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.
Jinru ShiaDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-4351-2511
Sergio GiraltDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0003-1944-5053
Miguel-Angel PeralesDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-5910-4571
Gillian MooreDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Samira FatmiDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Cristina SotoDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Antonio GomesDepartment of Immunology, Sloan Kettering Institute, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0003-3790-3724
Paul GiardinaDepartment of Immunology, Sloan Kettering Institute, Memorial Sloan Kettering Cancer Center, New York, NY.
LeeAnn MarcelloDepartment of Immunology, Sloan Kettering Institute, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-9801-5029
Xiaoqiang YanEvive Biotechnology (Shanghai) Ltd (formerly Generon [Shanghai] Corporation Ltd), Shanghai, China.
Tom TangEvive Biotechnology (Shanghai) Ltd (formerly Generon [Shanghai] Corporation Ltd), Shanghai, China.
Kevin DreyerEvive Biotechnology (Shanghai) Ltd (formerly Generon [Shanghai] Corporation Ltd), Shanghai, China.
Jianmin ChenEvive Biotechnology (Shanghai) Ltd (formerly Generon [Shanghai] Corporation Ltd), Shanghai, China.
William L DaleyEvive Biotechnology (Shanghai) Ltd (formerly Generon [Shanghai] Corporation Ltd), Shanghai, China.
Jonathan U PeledDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-4029-7625
Marcel R M van den BrinkDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Alan M HanashDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Memorial Sloan Kettering Cancer Center · USEvive Biotech (China) · CNCity Of Hope National Medical Center · USThe University of Texas MD Anderson Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
T LYMPHOCYTE SUBSET FUNCTION POST-TRANSPLANTATIONP01CA023766 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI PERALES, MIGUEL-ANGEL · 1985 to 2023
$59.0M
The role of intestinal microbiota in graft-versus-host diseaseR01CA228308 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI Philip L Lorenzi, Marcel R M van den Brink · 2018 to 2026
$5.2M
Discriminating EGFR function in T cells and epithelium during immune-mediated tissue damageR01HL146338 · NHLBI · SLOAN-KETTERING INST CAN RESEARCH · PI Alan M Hanash · 2018 to 2026
$4.8M
Regulation of the intestinal stem cell compartment after hematopoietic transplantationR01HL125571 · NHLBI · SLOAN-KETTERING INST CAN RESEARCH · PI Alan M Hanash · 2015 to 2026
$4.4M
IL-22 in Thymic RegenerationR01AI101406 · NIAID · SLOAN-KETTERING INST CAN RESEARCH · PI VAN DEN BRINK, MARCEL R M · 2012 to 2016
$2.5M
T cell invasion of the stem cell compartment during immune-mediated GI damageR01HL145631 · NHLBI · SLOAN-KETTERING INST CAN RESEARCH · PI HANASH, ALAN M · 2021 to 2024
$2.3M
Microbiota mechanisms and biomarkers in GVHDK08HL143189 · NHLBI · SLOAN-KETTERING INST CAN RESEARCH · PI PELED, JONATHAN · 2019 to 2023
$858k
NCI NIH HHS P01 CA023766NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA228308NHLBI NIH HHS K08 HL143189NHLBI NIH HHS R01 HL145631NIAID NIH HHS R01 AI101406
6 · The paper itself

Abstract

Graft-versus-host disease (GVHD) is a major cause of morbidity and mortality following allogeneic hematopoietic transplantation. In experimental models, interleukin-22 promotes epithelial regeneration and induces innate antimicrobial molecules. We conducted a multicenter single-arm phase 2 study evaluating the safety and efficacy of a novel recombinant human interleukin-22 dimer, F-652, used in combination with systemic corticosteroids for treatment of newly diagnosed lower gastrointestinal acute GVHD. The most common adverse events were cytopenias and electrolyte abnormalities, and there were no dose-limiting toxicities. Out of 27 patients, 19 (70%; 80% confidence interval, 56%-79%) achieved a day-28 treatment response, meeting the prespecified primary endpoint. Responders exhibited a distinct fecal microbiota composition characterized by expansion of commensal anaerobes, which correlated with increased overall microbial α-diversity, suggesting improvement of GVHD-associated dysbiosis. This work demonstrates a potential approach for combining immunosuppression with tissue-supportive strategies to enhance recovery of damaged mucosa and promote microbial health in patients with gastrointestinal GVHD. This trial was registered at www.clinicaltrials.gov as NCT02406651.

Indexed as

Graft vs Host DiseaseHematopoietic Stem Cell TransplantationAdrenal Cortex HormonesHumansInterleukin-22Lower Gastrointestinal TractRecombinant Fusion ProteinsAdrenal Cortex Hormoneseflepedocokin alfaInterleukin-22Recombinant Fusion Proteins

Identifiers

PMID36399701
PMCPMC10163318
OpenAlexW4309353208

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.