Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT05886491 for Leukemia is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Back to Search
TakedaA Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia Phase 1, Phase 2 16 Cell Therapy Novel Treatment
Clinical Trial NCT05886491 is designed to study Treatment for Leukemia. It is a Phase 1 Phase 2 interventional study that is active, not recruiting, having started on 11 July 2023, with plans to enroll 16 participants. Led by Takeda, it is expected to complete by 12 May 2026. The latest data from ClinicalTrials.gov was last updated on 5 February 2026.
Brief 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 GDX0...
Show MoreOfficial Title
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
Conditions
LeukemiaOther Study IDs
- TAK-012-1501
- jRCT2033240022 (Registry Identifier) (jRCT)
NCT ID Number
Start Date (Actual)
2023-07-11
Last Update Posted
2026-02-05
Completion Date (Estimated)
2026-05-12
Enrollment (Estimated)
16
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Active, not recruiting
Keywords
Drug Therapy
AML
acute myeloid leukemia
cell therapy
allogenic
gamma delta T cells
relapsed/ refractory
AML
acute myeloid leukemia
cell therapy
allogenic
gamma delta T cells
relapsed/ refractory
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPhase 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. |
ExperimentalPhase 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 1 month | |
Maximum Tolerated Dose (MTD) of GDX012 | Up to 1 month | |
Number of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. | Up to 14 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of Participants With Disease Response | Disease response includes participants achieving complete response \[CR\] complete response with incomplete hematologic recovery \[CRi\] (complete response with partial hematologic recovery \[CRh\] morphological leukemia-free state \[MLFS\] or partial response \[PR\] (based on 2022 European Leukemia Net \[ELN\] response criteria for AML after GDX012 administration. | Up to 14 months |
Number of Participants With Measurable Residual Disease (MRD) Negative Status as Determined by Flow Cytometry | Up to 14 months | |
Duration of Response (DOR) | DOR is defined as the time from the date of first documented CR, CRh, or CRi to the date of relapse or death. | Up to 14 months |
Event-free Survival (EFS) | EFS is defined as the time from the date of the first GDX012 administration to the date of treatment failure, relapse or death, whichever comes first. | Up to 14 months |
Overall Survival (OS) | OS is defined as the time from the date of the first GDX012 administration to the date of death. | Up to 14 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Total body weight of ≥40 kg.
Must have pathologically confirmed relapsed or refractory acute myeloid leukemia (R/R AML) including:
- 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.
- 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.
During dose escalation, participants must be ineligible for hematopoietic stem cell transplantation (HSCT).
Must have an anticipated life expectancy of >3 months before lymphodepletion.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Participants must have adequate renal, cardiac, hepatic, pulmonary and bone marrow function as defined by the protocol.
- Diagnosis of acute promyelocytic leukemia.
- Has received or plans to receive any of the excluded therapy/treatment within the specified timeframe before lymphodepleting chemotherapy as defined by the protocol.
- Prior allogeneic HSCT within 3 months of signing informed consent form (ICF) or with ongoing requirement for systemic graft-versus-host therapy.
- Active central nervous system (CNS) involvement.
- 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.
TakedaNo contact data.
11 Study Locations in 2 Countries
Alabama
University of Alabama at Birmingham (UAB) Hospital, Birmingham, Alabama, 35205, United States
California
City of Hope, Duarte, California, 91010, United States
Colorado
Sarah Cannon/CBCI, Denver, Colorado, 80218, United States
Illinois
Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, 60611, United States
Massachusetts
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Missouri
Washington University, St Louis, Missouri, 63110, United States
New York
Thomas Jefferson University, New York, New York, 10065, United States
Ohio
Cleveland Clinic, Cleveland, Ohio, 44195, United States
Tennessee
Tri-Star BMT/Sarah Cannon Nashville, Nashville, Tennessee, 37203, United States
Texas
MD Anderson Cancer Center, Houston, Texas, 77030, United States
National Cancer Center Hospital East, Kashiwa, 277-8577, Japan