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

Outcome

Outcome not reported

Stopped: “No expected efficacy was observed in subsequent extended phase.The company decided to initiatively terminate the development of IMM01 as monotherapy and fully promote clinical development of combination therapy.”

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