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A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia

NCT05886491 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-04-01

No results posted yet for this study

Summary

GDX012 is a novel cell therapy developed for the treatment of certain types of cancer, including Acute Myeloid Leukemia (AML). The main aims of the study are to learn how safe GDX012 is, how treatment with GDX012 is tolerated and to determine the best dose of GDX012.

Conditions

Interventions

DRUG

GDX012

GDX012 suspension for IV infusion.

DRUG

Chemotherapy Agents

Chemotherapy agents (fludarabine/cyclophosphamide) as per standard of care.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2025-08-20
Completion
2025-11-30
FDA Drug
Yes

Countries

  • United States
  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05886491 on ClinicalTrials.gov