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

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.

Conditions

Leukemia

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Leukemia
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham (UAB) Hospital, Birmingham, Alabama, United States, 35205-5802

Duarte

City of Hope, Duarte, California, United States, 91010-3012

Palo Alto

Stanford University, Palo Alto, California, United States, 94304-1812

Denver

Sarah Cannon/CBCI, Denver, Colorado, United States, 80218-1258

Chicago

Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, United States, 60611-3124

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110-1010

Buffalo

Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States, 14263-0001

New York

Thomas Jefferson University, New York, New York, United States, 10065-4870

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195-0001

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Takeda,

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

2027-06-30