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NCT05886491 | RECRUITING | Leukemia

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

Takeda

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.

Condition or disease

Leukemia

Intervention/treatment

GDX012

Chemotherapy Agents

Phase

PHASE1

PHASE2

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 GDX012 at one of the three dose levels: 1. GDX012 Dose 1 2. GDX012 Dose 2 3. GDX012 Dose 3 Upon completion of Phase 1, 1 to 2 dose levels will be selected for Phase 2a of the study. At the completion of Phase 2a of the study a single dose may be selected by the sponsor and investigators as the recommended phase 2 dose (RP2D) for future study. This multi-center trial will be conducted in the United States. The overall time to participate in the study is approximately 14 months.

Study Type : INTERVENTIONAL
Estimated Enrollment : 53 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-07-11
Estimated Primary Completion Date : 2026-04-01
Estimated Study Completion Date : 2027-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia

Location Details

NCT05886491

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Albama

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Albama, United States, 35205-5802

RECRUITING

United States, California

City of Hope

Duarte, California, United States, 91010-3012

NOT YET RECRUITING

United States, California

Stanford University

Palo Alto, California, United States, 94304-1812

NOT YET RECRUITING

United States, Colorado

Sarah Cannon/CBCI

Denver, Colorado, United States, 80218-1258

NOT YET RECRUITING

United States, Illinois

Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States, 60611-3124

NOT YET RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

NOT YET RECRUITING

United States, Missouri

Washington University

Saint Louis, Missouri, United States, 63110-1010

NOT YET RECRUITING

United States, New York

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14263-0001

RECRUITING

United States, New York

Thomas Jefferson University

New York, New York, United States, 10065-4870

RECRUITING

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195-0001

NOT YET RECRUITING

United States, Oregon

OHSU Knight Cancer Institute

Portland, Oregon, United States, 97239-3011

RECRUITING

United States, Tennessee

Tri-Star BMT/Sarah Cannon Nashville

Nashville, Tennessee, United States, 37203-6521

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

NOT YET RECRUITING

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226-3522