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IO-202 as Monotherapy and IO-202 Plus Azacitidine ± Venetoclax in Patients in AML and CMML

NCT04372433 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-02-14

No results posted yet for this study

Summary

To assess safety and tolerability at increasing dose levels of IO-202 in successive cohorts of participants with AML with monocytic differentiation and CMML in order to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D)

Conditions

  • AML With Monocytic Differentiation
  • CMML

Interventions

BIOLOGICAL

IO-202

IO-202 as monotherapy

BIOLOGICAL

IO-202 and Azacitidine

IO-202 and azacitidine combination therapy

BIOLOGICAL

IO-202 and Azacitidine + Venetoclax

IO-202 and azacitidine + venetoclax combination therapy

BIOLOGICAL

IO-202 and Azacitidine

IO-202 and azacitidine combination therapy

Sponsors & Collaborators

  • California Institute for Regenerative Medicine (CIRM)

    collaborator OTHER

  • Immune-Onc Therapeutics

    lead INDUSTRY

Principal Investigators

  • Hong Xiang, PhD · Immune-Onc Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04372433 on ClinicalTrials.gov