GDX012 treatment for 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
This study is testing a new cell therapy called GDX012 to see if it can help adults with relapsed or hard-to-treat acute myeloid leukemia feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 14 sites (Birmingham, Alabama and 13 other locations) |
| Trial ID | NCT05886491 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates GDX012, a novel cell therapy, for adults suffering from relapsed or refractory acute myeloid leukemia (AML). The study consists of two phases: a dose escalation phase to determine the safety and tolerability of GDX012 at different dose levels, followed by a dose expansion phase to identify the recommended phase 2 dose for future studies. Approximately 53 patients will be enrolled across multiple centers in the United States, with a total participation time of about 14 months.
Who should consider this trial
Good fit: Ideal candidates include adults with relapsed or refractory AML who are ineligible for hematopoietic stem cell transplantation.
Not a fit: Patients with non-relapsed AML or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat AML.
How similar studies have performed: While there have been studies on cell therapies for AML, the specific approach with GDX012 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Total body weight of ≥40 kg. 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: 1. Diagnosis of acute promyelocytic leukemia. 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.
Where this trial is running
Birmingham, Alabama and 13 other locations
- University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States (Not_yet_recruiting)
- City of Hope — Duarte, California, United States (Recruiting)
- Stanford University — Palo Alto, California, United States (Not_yet_recruiting)
- Sarah Cannon/CBCI — Denver, Colorado, United States (Not_yet_recruiting)
- Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States (Not_yet_recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Not_yet_recruiting)
- Washington University — Saint Louis, Missouri, United States (Not_yet_recruiting)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Not_yet_recruiting)
- Thomas Jefferson University — New York, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- OHSU Knight Cancer Institute — Portland, Oregon, United States (Not_yet_recruiting)
- Tri-Star BMT/Sarah Cannon Nashville — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.