NCT05886491

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

A Phase 1/2a, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety and Efficacy of GDX012 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study is called GDX012. GDX012 is being tested to evaluate the safety and tolerability in adult participants with AML. The study will enroll approximately 53 patients in two phases, dose escalation and dose expansion. During Phase 1 (sequential dose escalation), participants will be assigned to one of the following treatment groups each consisting of 3 to 6 participants to receive GDX012 at one of the three dose levels: 1. GDX012 Dose 1 2. GDX012 Dose 2 3. GDX012 Dose 3 Upon completion of Phase 1, 1 to 2 dose levels will be selected for Phase 2a of the study. At the completion of Phase 2a of the study a single dose may be selected by the sponsor and investigators as the recommended phase 2 dose (RP2D) for future study. This multi-center trial will be conducted in the United States. The overall time to participate in the study is approximately 14 months.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	GDX012	GDX012 suspension for IV infusion.
DRUG	Chemotherapy Agents	Chemotherapy agents (fludarabine/cyclophosphamide) as per standard of care.

Timeline

• Start date: 2023-07-11
• Primary completion: 2025-08-20
• Completion: 2025-11-30
• First posted: 2023-06-02
• Last updated: 2026-04-01

Locations

11 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study