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A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia - Trial NCT05886491

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.

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NCT05886491
Phase 1/2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05886491
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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

Study Focus

Leukemia

GDX012

Interventional

drug

Sponsor & Location

Takeda

California City,Chicago,Houston, United States of America

Timeline & Enrollment

Phase 1/2

Jul 07, 2023

Jun 30, 2027

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, unspecified
Myeloid leukaemia
Myeloid leukaemia, unspecified
Other myeloid leukaemia
Monocytic leukaemia, unspecified

Data Source

ClinicalTrials.gov

NCT05886491

Non-Device Trial