NCT05140811

A Study of IMM01 Combined With Azacitidine in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Phase 1/Phase 2 Study of IMM01 Combined With Azacitidine in Patients With AML and MDS

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is an open-lable , multi-center, Phase 1/Phase 2 study that will evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and and immunogenicity of IMM01 combined with Azacitidine in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS).

Detailed description

Main study purpose: * To evaluate the safety and tolerability of IMM01 combined with Azacitidine in patients with AML and MDS. * To explore the Maximum Tolerated Dose (MTD) of IMM01 combined with Azacitidine, and determine the phase 2 clinical recommended dose (RP2D) of IMM01 combined with Azacitidine. Secondary study purpose: * To evaluate the efficacy of IMM01 combined with Azacitidine in patients with AML and MDS. * To evaluate the Pharmacokinetics and Pharmacodynamics of IMM01 combined with Azacitidine, in patients with AML and MDS. Exploratory study purpose: • To evaluate the immunogenicity of IMM01 combined with Azacitidine in patients with AML and MDS.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	IMM01	IMM01 is intravenously once a week, every 28 days for a treatment cycle;
DRUG	Azacitidine	Azacitidine 75 mg/m/ day is administered subcutaneously for 7 consecutive days, with each 28-day treatment cycle planned for 6 treatment cycles

Timeline

• Start date: 2022-01-05
• Primary completion: 2024-02-05
• Completion: 2024-03-01
• First posted: 2021-12-01
• Last updated: 2023-05-24

Locations

22 sites across 1 country: China