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

Stopped early · Phase 1/Phase 2

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT05886491

Run by

Takeda

People needed

16

Starts

2023-07-11

Expected to finish

2025-11-30

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States
• City of Hope — Duarte, 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
• Thomas Jefferson University — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Tri-Star BMT/Sarah Cannon Nashville — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• National Cancer Center Hospital East — Kashiwa, Japan

Full record on ClinicalTrials.gov

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