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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
Phase 1 trial testing F16IL2 in Acute Myeloid Leukemia, Relapsed, Adult in 30 participants. Terminated before completion.
29 September 2023
Quick facts
| Lead sponsor | Philogen S.p.A. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 13 April 2016 |
| Primary completion | 29 September 2023 |
| Estimated completion | 29 September 2023 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- F16IL2 — full drug profile →
- cytarabine — full drug profile →
Conditions studied
- Acute Myeloid Leukemia, Relapsed, Adult — all drugs for Acute Myeloid Leukemia, Relapsed, Adult →
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):
-
Current progress in innovative engineered antibodies.
Strohl WR. · · 2018 · cited 169× · PMID 28822103 · DOI 10.1007/s13238-017-0457-8 -
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 -
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 -
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 -
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 -
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 -
Utilizing Immunocytokines for Cancer Therapy.
Runbeck E, Crescioli S, Karagiannis SN, Papa S. · · 2021 · cited 33× · PMID 33803078 · DOI 10.3390/antib10010010 -
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:
- PubMed search for NCT02957032
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of F16IL2
Trials testing the same drug.
- NCT03207191 — Trial to Find and Investigate a Safe Dose of F16IL2 and BI 836858 in Patients With AML Relapse After Allogeneic Hematopo · Phase 1 · completed
Other Philogen S.p.A. trials
Trials by the same sponsor.
- NCT07120984 — A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutan · Phase 2 · not yet recruiting
- NCT06640413 — A Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L1 · Phase 1 · recruiting
- NCT06840548 — A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoCAIX in Patients With CAIX-positive Cancer · Phase 1 · completed
- NCT06840535 — A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoACP3 in Patients With Prostate Cancer · Phase 1 · completed
- NCT05784597 — A Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Solid Tumors · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02957032 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Philogen S.p.A.
- Last refreshed: 10 October 2023
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.
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