NCT05860075

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hematologic Malignancy

Interventions

Type	Name	Description
DRUG	IMM01	IMM01 will be administered once a week for 4 weeks.

Timeline

• Start date: 2019-11-19
• Primary completion: 2022-10-26
• Completion: 2022-10-26
• First posted: 2023-05-16
• Last updated: 2023-05-16

Locations

1 site across 1 country: China