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Een studie van GDX012 bij volwassenen met recidiverende of refractaire acute myeloïde leukemie

2 september 2026 bijgewerkt door: Takeda

Een fase 1/2a, open-label, dosisescalatie en dosisuitbreidingsonderzoek om de veiligheid en werkzaamheid van GDX012 te beoordelen bij patiënten met recidiverende of refractaire acute myeloïde leukemie

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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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 and Japan. The overall time to participate in the study is approximately 14 months.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

16

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Japan
      • Kashiwa, Japan, 277-8577
        • National Cancer Center Hospital East
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35205
        • University of Alabama at Birmingham (UAB) Hospital
    • California
      • Duarte, California, Verenigde Staten, 91010
        • City of Hope
    • Colorado
      • Denver, Colorado, Verenigde Staten, 80218
        • Sarah Cannon/CBCI
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60611
        • Comprehensive Cancer Center of Northwestern University
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Dana-Farber Cancer Institute
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63110
        • Washington University
    • New York
      • New York, New York, Verenigde Staten, 10065
        • Thomas Jefferson University
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44195
        • Cleveland Clinic
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Tri-Star BMT/Sarah Cannon Nashville
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • MD Anderson Cancer Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Phase 1: Dose Escalation of GDX012 (Dose Level 1)

Participants received GDX012 weight-based dose level 1 as an intravenous (IV) infusion on Day 1 of Phase 1, following lymphodepleting chemotherapy. Dose Level 1 was the lowest dose level.
Geneesmiddel: GDX012

GDX012 suspension for IV infusion.

Andere namen:
  • TAK-012
Geneesmiddel: Chemotherapy Agents

Chemotherapy agents (fludarabine/cyclophosphamide) as per standard of care.
Experimenteel: Phase 1: Dose Escalation of GDX012 (Dose Level 2)

Participants received GDX012 weight-based dose level 2 as an IV infusion on Day 1 of Phase 1, following lymphodepleting chemotherapy. Dose Level 2 was higher than Dose Level 1.
Geneesmiddel: GDX012

GDX012 suspension for IV infusion.

Andere namen:
  • TAK-012
Geneesmiddel: Chemotherapy Agents

Chemotherapy agents (fludarabine/cyclophosphamide) as per standard of care.
Experimenteel: Phase 1: Dose Escalation of GDX012 (Dose Level 3)

Participants received GDX012 weight-based dose level 3 as an IV infusion on Day 1 of Phase 1, following lymphodepleting chemotherapy. Dose Level 3 was higher than Dose Level 2.
Geneesmiddel: GDX012

GDX012 suspension for IV infusion.

Andere namen:
  • TAK-012
Geneesmiddel: Chemotherapy Agents

Chemotherapy agents (fludarabine/cyclophosphamide) as per standard of care.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Dose Limiting Toxicities (DLTs) to Determine the Maximum Tolerated Dose (MTD) of GDX012
Tijdsspanne: Up to 30 days post infusion

DLTs were defined as events occurring by Day 30 after the first GDX012 infusion considered related to GDX012 if they could not be explained by underlying disease, prior therapy, intercurrent illness, or lymphodepleting chemotherapy. Events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. DLTs included severe non-hematologic toxicities (Grade 3-4, unresolved or involving vital organs), Grade ≥3 graft versus host disease (GvHD) graded per the Mount Sinai Acute GvHD International Consortium recommendations and 2014 National Institutes of Health (NIH) Consensus, Grade 3-4 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) per American Society for Transplantation and Cellular Therapy (ASTCT) criteria, Grade ≥3 infusion reactions or tumor lysis syndrome (TLS), persistent cytopenia or marrow hypocellularity, and any Grade 5 toxicity attributable to GDX012.
Up to 30 days post infusion
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Tijdsspanne: Up to 14 months

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event or a previous condition that has increased in severity or frequency since the administration of study drug. TEAEs are defined as any AE that begins on or after the initiation of treatment with a study intervention or any existing event that worsens following exposure to the study intervention.
Up to 14 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Disease Response
Tijdsspanne: Up to 14 months

Percentage of participants with disease response included participants who achieved complete response (CR), complete response with partial hematologic recovery (CRh), or complete response with incomplete hematologic recovery (CRi), based on responses assessed by the investigator according to the 2022 European Leukemia Net [ELN] response criteria for acute myeloid leukemia (AML). CR was defined as the sum of complete remission and complete remission without measurable residual disease (MRD). CRh was defined as the sum of CRh and CRhMRD-. CRi was defined as the sum of CRi and CRiMRD-.
Up to 14 months
Percentage of Participants With Measurable Residual Disease (MRD) Negative Status as Determined by Flow Cytometry
Tijdsspanne: Up to 14 months

The MRD negative status was defined as (less than) <0.1% detectable disease based on local assessment of bone marrow and/or blood.
Up to 14 months
Duration of Response (DOR)
Tijdsspanne: Up to 14 months

DOR was planned to be assessed for participants with CR, CRh, or CRi and was defined as the time from the date of first documented CR, CRh, or CRi to the date of first documented relapse or death from any cause, whichever comes first. CR was defined as the sum of Complete Remission and Complete Remission without MRD. CRh was defined as the sum of CRh and CRhMRD-. CRi was defined as the sum of CRi and CRiMRD- .
Up to 14 months
Event-free Survival (EFS)
Tijdsspanne: Up to 14 months

EFS was defined as the time from the date of the first GDX012 administration to the date of treatment failure, relapse for those who achieved CR, CRh, or CRi, or death from any cause, whichever came first. CR was defined as the sum of Complete Remission and Complete Remission without MRD (CRMRD-). CRh was defined as the sum of CRh and CRhMRD-. CRi was defined as the sum of CRi and CRiMRD-. EFS was analyzed using the Kaplan-Meier method.
Up to 14 months
Overall Survival (OS)
Tijdsspanne: Up to 14 months

OS was defined as the time from the date of the first GDX012 administration to the date of death from any cause. Participants without documentation of death at the time of analysis were censored at the last contact date. OS was analyzed using the Kaplan-Meier method.
Up to 14 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Takeda

Onderzoekers

  • Studie directeur: Medical Director, Takeda

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 juli 2023

Primaire voltooiing (Werkelijk)

20 augustus 2025

Studie voltooiing (Werkelijk)

30 november 2025

Studieregistratiedata

Eerst ingediend

24 mei 2023

Eerst ingediend dat voldeed aan de QC-criteria

24 mei 2023

Eerst geplaatst (Werkelijk)

2 juni 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

2 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TAK-012-1501
  • jRCT2033240022 (Register-ID: jRCT)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD-toegangscriteria voor delen

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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