Last reviewed · How we verify

NCT02957032

A Study of the Tumor-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Very Low-dose Cytarabine in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

Terminated Phase 1 Last updated 10 October 2023
What this trial tests

Phase 1 trial testing F16IL2 in Acute Myeloid Leukemia, Relapsed, Adult in 30 participants. Terminated before completion.

Timeline
13 April 2016
Primary endpoint
29 September 2023
29 September 2023

Quick facts

Lead sponsorPhilogen S.p.A.
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date13 April 2016
Primary completion29 September 2023
Estimated completion29 September 2023
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Philogen S.p.A. — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia, Relapsed, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Phase I, open label, non-randomized, multicenter, prospective dose escalation study of F16IL2 in combination with very low-dose cytarabine in subjects with acute myeloid leukemia relapse after allogeneic hematopoietic stem cell transplantation (alloHSCT).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current progress in innovative engineered antibodies.
    Strohl WR. · · 2018 · cited 169× · PMID 28822103 · DOI 10.1007/s13238-017-0457-8
  2. A systematic review of interleukin-2-based immunotherapies in clinical trials for cancer and autoimmune diseases.
    Raeber ME, Sahin D, Karakus U, Boyman O. · · 2023 · cited 139× · PMID 37004361 · DOI 10.1016/j.ebiom.2023.104539
  3. Engineering cytokine therapeutics.
    Deckers J, Anbergen T, Hokke AM, de Dreu A, et al · · 2023 · cited 132× · PMID 37064653 · DOI 10.1038/s44222-023-00030-y
  4. The use of supercytokines, immunocytokines, engager cytokines, and other synthetic cytokines in immunotherapy.
    Zheng X, Wu Y, Bi J, Huang Y, et al · · 2022 · cited 112× · PMID 35043005 · DOI 10.1038/s41423-021-00786-6
  5. Antibody-cytokine fusion proteins: A novel class of biopharmaceuticals for the therapy of cancer and of chronic inflammation.
    Murer P, Neri D. · · 2019 · cited 67× · PMID 30991144 · DOI 10.1016/j.nbt.2019.04.002
  6. The present and future of immunocytokines for cancer treatment.
    Gout DY, Groen LS, van Egmond M. · · 2022 · cited 41× · PMID 36066630 · DOI 10.1007/s00018-022-04514-9
  7. Utilizing Immunocytokines for Cancer Therapy.
    Runbeck E, Crescioli S, Karagiannis SN, Papa S. · · 2021 · cited 33× · PMID 33803078 · DOI 10.3390/antib10010010
  8. Therapeutic Antibodies for Myeloid Neoplasms-Current Developments and Future Directions.
    Schürch CM. · · 2018 · cited 30× · PMID 29868474 · DOI 10.3389/fonc.2018.00152

Verify or expand the search:

Other trials of F16IL2

Trials testing the same drug.

Other Philogen S.p.A. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02957032.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing