ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2023-07-11
Study Completion:2026-05-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05886491

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Total body weight of ≥40 kg.
  2. 2. Must have pathologically confirmed relapsed or refractory acute myeloid leukemia (R/R AML) including:
  3. 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.
  4. 2. Refractory AML is defined as failure to achieve a CR, CRh, Cri, or MLFS after 1 of the following regimens:
  5. 3. During dose escalation, participants must be ineligible for hematopoietic stem cell transplantation (HSCT).
  6. 4. Must have an anticipated life expectancy of \>3 months before lymphodepletion.
  7. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  8. 6. Participants must have adequate renal, cardiac, hepatic, pulmonary and bone marrow function as defined by the protocol.
  1. 1. Diagnosis of acute promyelocytic leukemia.
  2. 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. 3. Prior allogeneic HSCT within 3 months of signing informed consent form (ICF) or with ongoing requirement for systemic graft-versus-host therapy.
  4. 4. Active central nervous system (CNS) involvement.
  5. 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.

Contacts and Locations

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35205-5802
United States
City of Hope
Duarte, California, 91010-3012
United States
Stanford University
Palo Alto, California, 94304-1812
United States
Sarah Cannon/CBCI
Denver, Colorado, 80218-1258
United States
Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611-3124
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Washington University
Saint Louis, Missouri, 63110-1010
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263-0001
United States
Thomas Jefferson University
New York, New York, 10065-4870
United States
Cleveland Clinic
Cleveland, Ohio, 44195-0001
United States
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3011
United States
Tri-Star BMT/Sarah Cannon Nashville
Nashville, Tennessee, 37203-6521
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-11
Study Completion Date2026-05-12

Study Record Updates

Study Start Date2023-07-11
Study Completion Date2026-05-12

Terms related to this study

Keywords Provided by Researchers

  • Drug Therapy
  • AML
  • acute myeloid leukemia
  • cell therapy
  • allogenic
  • gamma delta T cells
  • relapsed/ refractory

Additional Relevant MeSH Terms

  • Leukemia