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

Primary Purpose

Leukemia

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GDX012
Chemotherapy Agents
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Drug Therapy, AML, acute myeloid leukemia, cell therapy, allogenic, gamma delta T cells, relapsed/ refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: 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. Exclusion criteria: 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.

Sites / Locations

  • University of Alabama at Birmingham (UAB) Hospital
  • City of HopeRecruiting
  • Stanford University
  • Sarah Cannon/CBCI
  • Comprehensive Cancer Center of Northwestern University
  • Dana-Farber Cancer Institute
  • Washington University
  • Roswell Park Comprehensive Cancer Center
  • Thomas Jefferson University
  • Cleveland Clinic
  • OHSU Knight Cancer Institute
  • Tri-Star BMT/Sarah Cannon NashvilleRecruiting
  • MD Anderson Cancer Center
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase 1: Dose Escalation of GDX012

Phase 2a: GDX012

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Dose Limiting Toxicities (DLTs)
Maximum Tolerated Dose (MTD) of GDX012
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.

Secondary Outcome Measures

Number of Participants With Disease Response
Disease response includes participants achieving complete response [CR] complete response with incomplete hematologic recovery [CRi] (complete response with partial hematologic recovery [CRh] morphological leukemia-free state [MLFS] or partial response [PR] (based on 2022 European Leukemia Net [ELN] response criteria for AML after GDX012 administration.
Number of Participants With Measurable Residual Disease (MRD) Negative Status as Determined by Flow Cytometry
Duration of Response (DOR)
DOR is defined as the time from the date of first documented CR, CRh, or CRi to the date of relapse or death.
Event-free Survival (EFS)
EFS is defined as the time from the date of the first GDX012 administration to the date of treatment failure, relapse or death, whichever comes first.
Overall Survival (OS)
OS is defined as the time from the date of the first GDX012 administration to the date of death.

Full Information

First Posted
May 24, 2023
Last Updated
October 12, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT05886491
Brief Title
A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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: GDX012 Dose 1 GDX012 Dose 2 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
Drug Therapy, AML, acute myeloid leukemia, cell therapy, allogenic, gamma delta T cells, relapsed/ refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Dose Escalation of GDX012
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase 2a: GDX012
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GDX012
Intervention Description
GDX012 suspension for IV infusion.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy Agents
Intervention Description
Chemotherapy agents (fludarabine/cyclophosphamide) as per standard of care.
Primary Outcome Measure Information:
Title
Number of Participants With Dose Limiting Toxicities (DLTs)
Time Frame
Up to 1 month
Title
Maximum Tolerated Dose (MTD) of GDX012
Time Frame
Up to 1 month
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to 14 months
Secondary Outcome Measure Information:
Title
Number of Participants With Disease Response
Description
Disease response includes participants achieving complete response [CR] complete response with incomplete hematologic recovery [CRi] (complete response with partial hematologic recovery [CRh] morphological leukemia-free state [MLFS] or partial response [PR] (based on 2022 European Leukemia Net [ELN] response criteria for AML after GDX012 administration.
Time Frame
Up to 14 months
Title
Number of Participants With Measurable Residual Disease (MRD) Negative Status as Determined by Flow Cytometry
Time Frame
Up to 14 months
Title
Duration of Response (DOR)
Description
DOR is defined as the time from the date of first documented CR, CRh, or CRi to the date of relapse or death.
Time Frame
Up to 14 months
Title
Event-free Survival (EFS)
Description
EFS is defined as the time from the date of the first GDX012 administration to the date of treatment failure, relapse or death, whichever comes first.
Time Frame
Up to 14 months
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of the first GDX012 administration to the date of death.
Time Frame
Up to 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB) Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
205-934-9591
Email
pvachhani@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Pankit Vachhani
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
626-218-2405
Email
malmalki@coh.org
First Name & Middle Initial & Last Name & Degree
MONZR AL MALKI
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
650-353-6404
Email
alice1@stanford.edu
First Name & Middle Initial & Last Name & Degree
Alice Bertaina
Facility Name
Sarah Cannon/CBCI
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
720-754-4800
Email
Alireza.Eghtedar@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Alireza Eghtedar
Facility Name
Comprehensive Cancer Center of Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
312-503-1817
Email
j-altman@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Jessica Altman
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
617-632-1906
Email
evan_chen@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Evan CHEN
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
314-455-8317
Email
jdipersi@wustl.edu
First Name & Middle Initial & Last Name & Degree
John DiPersio
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
716-845-3544
Email
eunice.wang@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Eunice Wang
Facility Name
Thomas Jefferson University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
215-955-4367
Email
usama.gergis@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Usama Gergis
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
216-444-2200
Email
mustafm8@ccf.org
First Name & Middle Initial & Last Name & Degree
Moaath Mustafa Ali
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
503-494-5566
Email
saultzje@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Saultz
Facility Name
Tri-Star BMT/Sarah Cannon Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
615-342-7440
Email
Stephen.Strickland@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Stephen Strickland
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
713-563-1487
Email
amaiti@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Abhishek Maiti
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
414-805-8753
Email
kabarker@mcw.edu
First Name & Middle Initial & Last Name & Degree
Karen Carlson

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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 Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/takeda/

Learn more about this trial

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

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