NCT05886491

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_1 leukemia

Geographic Reach
2 countries

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 11, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

May 24, 2023

Last Update Submit

March 26, 2026

Conditions

Leukemia

Keywords

Drug TherapyAMLacute myeloid leukemiacell therapyallogenicgamma delta T cellsrelapsed/ refractory

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Dose Limiting Toxicities (DLTs)

    Up to 1 month

  • Maximum Tolerated Dose (MTD) of GDX012

    Up to 1 month

  • Number of Participants With Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.

    Up to 14 months

Secondary Outcomes (5)

  • Number of Participants With Disease Response

    Up to 14 months

  • Number of Participants With Measurable Residual Disease (MRD) Negative Status as Determined by Flow Cytometry

    Up to 14 months

  • Duration of Response (DOR)

    Up to 14 months

  • Event-free Survival (EFS)

    Up to 14 months

  • Overall Survival (OS)

    Up to 14 months

Study Arms (2)

Phase 1: Dose Escalation of GDX012

EXPERIMENTAL

Participants will receive GDX012 weight-based dose as intravenous (IV) infusion on Day 1 of Phase 1 after lymphodepleting chemotherapy. Three dose levels of GDX012 will be tested in Phase 1. Some participants may be eligible for a second dose.

Drug: GDX012Drug: Chemotherapy Agents

Phase 2a: GDX012

EXPERIMENTAL

Participants will receive GDX012 (weight-based) IV infusion at pre-selected one or two dose levels from Phase 1, on Day 1 after lymphodepleting chemotherapy. Some participants may be eligible for a second dose.

Drug: GDX012Drug: Chemotherapy Agents

Interventions

GDX012DRUG

GDX012 suspension for IV infusion.

Phase 1: Dose Escalation of GDX012Phase 2a: GDX012
Chemotherapy AgentsDRUG

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

Phase 1: Dose Escalation of GDX012Phase 2a: GDX012

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Total body weight of ≥40 kg.
  • Must have pathologically confirmed relapsed or refractory acute myeloid leukemia (R/R AML) including:
  • 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.
  • 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.
  • During dose escalation, participants must be ineligible for hematopoietic stem cell transplantation (HSCT).
  • Must have an anticipated life expectancy of \>3 months before lymphodepletion.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Participants must have adequate renal, cardiac, hepatic, pulmonary and bone marrow function as defined by the protocol.

You may not qualify if:

  • Diagnosis of acute promyelocytic leukemia.
  • Has received or plans to receive any of the excluded therapy/treatment within the specified timeframe before lymphodepleting chemotherapy as defined by the protocol.
  • Prior allogeneic HSCT within 3 months of signing informed consent form (ICF) or with ongoing requirement for systemic graft-versus-host therapy.
  • Active central nervous system (CNS) involvement.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama, 35205, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Sarah Cannon/CBCI

Denver, Colorado, 80218, United States

Location

Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Thomas Jefferson University

New York, New York, 10065, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Tri-Star BMT/Sarah Cannon Nashville

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

National Cancer Center Hospital East

Kashiwa, 277-8577, Japan

Location

Related Links

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 2, 2023

Study Start

July 11, 2023

Primary Completion

August 20, 2025

Study Completion

November 30, 2025

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Access Criteria
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.
More information

Locations

US(10)JP(1)