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

Hematologic Malignancy Clinical Trial

Official title:
A Phase 1 Clinical Study to Evaluate IMM01 Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Patients With Refractory or Recurrent Hematologic Malignancy

Clinical Trial 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.

Clinical Trial Description

IMM01 is administered via intravenous infusion once week of cycle 1- 12 (4 weeks per cycle). The accelerated titration method and the traditional "3+3" method will be adopted to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) in dose-escalation phase. Once the RP2D is determined, will explore for Classic Hodgkin's lymphoma, B-cell lymphoma,NK/T-cell lymphoma, AML, MDS and MM cohorts. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05860075
Study type Interventional
Source ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Contact
Status Terminated
Phase Phase 1
Start date November 19, 2019
Completion date October 26, 2022
View Details
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