A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia
NCT ID: NCT05886491
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
14 participants
INTERVENTIONAL
2023-07-11
2026-05-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Find a Safe and Effective Dose of SKI-G-801 in the Treatment of Patients With Acute Myeloid Leukemia (AML)
NCT03564288
A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
NCT05732103
A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia
NCT05748197
A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies
NCT03106428
Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias
NCT00920140
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1: Dose Escalation of GDX012
Participants will receive GDX012 weight-based dose as intravenous (IV) infusion on Day 1 of Phase 1 after lymphodepleting chemotherapy. Three dose levels of GDX012 will be tested in Phase 1. Some participants may be eligible for a second dose.
GDX012
GDX012 suspension for IV infusion.
Chemotherapy Agents
Chemotherapy agents (fludarabine/cyclophosphamide) as per standard of care.
Phase 2a: GDX012
Participants will receive GDX012 (weight-based) IV infusion at pre-selected one or two dose levels from Phase 1, on Day 1 after lymphodepleting chemotherapy. Some participants may be eligible for a second dose.
GDX012
GDX012 suspension for IV infusion.
Chemotherapy Agents
Chemotherapy agents (fludarabine/cyclophosphamide) as per standard of care.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GDX012
GDX012 suspension for IV infusion.
Chemotherapy Agents
Chemotherapy agents (fludarabine/cyclophosphamide) as per standard of care.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Must have pathologically confirmed relapsed or refractory acute myeloid leukemia (R/R AML) including:
1. Relapsed AML is defined as ≥5% blasts in the bone marrow (BM) or peripheral blood at any time after achieving a CR, CRh, Cri, or MLFS.
2. Refractory AML is defined as failure to achieve a CR, CRh, Cri, or MLFS after 1 of the following regimens:
i. Two courses of intensive induction chemotherapy. ii. At least 2 cycles of hypomethylating agent (HMA) or low-dose, cytarabine-based combination regimen.
iii. At least 4 cycles of HMA monotherapy.
3. During dose escalation, participants must be ineligible for hematopoietic stem cell transplantation (HSCT).
4. Must have an anticipated life expectancy of \>3 months before lymphodepletion.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
6. Participants must have adequate renal, cardiac, hepatic, pulmonary and bone marrow function as defined by the protocol.
Exclusion Criteria
2. Has received or plans to receive any of the excluded therapy/treatment within the specified timeframe before lymphodepleting chemotherapy as defined by the protocol.
3. Prior allogeneic HSCT within 3 months of signing informed consent form (ICF) or with ongoing requirement for systemic graft-versus-host therapy.
4. Active central nervous system (CNS) involvement.
5. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg. cervix, bladder, breast) low grade prostate cancer without treatment requirement unless in remission without treatment for ≥2 years.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
Stanford University
Palo Alto, California, United States
Sarah Cannon/CBCI
Denver, Colorado, United States
Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Thomas Jefferson University
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Tri-Star BMT/Sarah Cannon Nashville
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
jRCT2033240022
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-012-1501
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.