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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
Takeda·Phase 1/2·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Leukemia
Drug/Device/Intervention
GDX012
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Takeda
Location
California City,Chicago,Houston, United States of America
Timeline & enrollment
Phase
Phase 1/2
Start date
Jul 07, 2023
End date
Jun 30, 2027
Enrollment
53 participants
Primary outcome

Number of Participants With Dose Limiting Toxicities (DLTs),Maximum Tolerated Dose (MTD) of GDX012,Number of Participants With Adverse Events (AEs)

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.

ICD-10 classifications
Leukaemia, unspecifiedMyeloid leukaemiaMyeloid leukaemia, unspecifiedOther myeloid leukaemiaMonocytic leukaemia, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05886491
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05886491 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Takeda and is currently Not yet recruiting. The study focuses on Leukemia. Target enrollment is 53 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.