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 Terminated 30 enrolled Philogen S.p.A.

NaSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start: 2016-04-13
Primary completion: 2023-09-29
Completion: 2023-09-29

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	F16IL2	Protein / enzyme biologic	—	—
Background	Cytarabine	Small molecule	5 mg	Subcutaneous

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

Summary

Timeline

Drugs

Indications