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

NCT05140811 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-05-24

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    collaborator OTHER

  • ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-05
Primary Completion
2024-02-05
Completion
2024-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05140811 on ClinicalTrials.gov