drugset
drugset / Trial / NCT05860075

Exploratory Study of IMM01 for Injection in the Treatment of Refractory or Recurrent Hematologic Malignancy

NCT05860075 ↗

Phase 1 Terminated 73 enrolled ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a multi-center, open-label, dose-escalation and cohort-expansion phase I clinical study to evaluate the safety and tolerability, pharmacokinetics profile, efficacy and immunogenicity of IMM01 in subjects with refractory or recurrent hematologic malignancy.

Timeline

Start
2019-11-19
Primary completion
2022-10-26
Completion
2022-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject IMM01 Protein / enzyme biologic 3 ug/kg Intravenous
Subject IMM01 Protein / enzyme biologic 10 ug/kg Intravenous
Subject IMM01 Protein / enzyme biologic 50 ug/kg Intravenous
Subject IMM01 Protein / enzyme biologic 150 ug/kg Intravenous
Subject IMM01 Protein / enzyme biologic 500 ug/kg Intravenous
Subject IMM01 Protein / enzyme biologic 1 mg/kg Intravenous
Subject IMM01 Protein / enzyme biologic 1.5 mg/kg Intravenous
Subject IMM01 Protein / enzyme biologic 2 mg/kg Intravenous

Indications

hematopoietic and lymphoid cell neoplasm