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

Phase 1

Recruiting

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:

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Phase 1: Dose Escalation of GDX012	Chemotherapy Agents	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.
Phase 2a: GDX012	GDX012	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.
Phase 2a: GDX012	Chemotherapy Agents	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.
Phase 1: Dose Escalation of GDX012	GDX012	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Up to 14 months	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.
Number of Participants With Dose Limiting Toxicities (DLTs)	Up to 1 month
Maximum Tolerated Dose (MTD) of GDX012	Up to 1 month

Secondary Outcome Measures

Name	Time	Method
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	DOR is defined as the time from the date of first documented CR, CRh, or CRi to the date of relapse or death.
Number of Participants With Disease Response	Up to 14 months	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.
Overall Survival (OS)	Up to 14 months	OS is defined as the time from the date of the first GDX012 administration to the date of death.
Event-free Survival (EFS)	Up to 14 months	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.

Locations (14): Tri-Star BMT/Sarah Cannon Nashville
🇺🇸
Nashville, Tennessee, United States
Dana-Farber Cancer Institute
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Boston, Massachusetts, United States
Comprehensive Cancer Center of Northwestern University
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Chicago, Illinois, United States
MD Anderson Cancer Center
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Houston, Texas, United States
Roswell Park Comprehensive Cancer Center
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Buffalo, New York, United States
Cleveland Clinic
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Cleveland, Ohio, United States
University of Alabama at Birmingham (UAB) Hospital
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Birmingham, Alabama, United States
Sarah Cannon/CBCI
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Denver, Colorado, United States
City of Hope
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Duarte, California, United States
Washington University
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Saint Louis, Missouri, United States
OHSU Knight Cancer Institute
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Portland, Oregon, United States
Medical College of Wisconsin
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Milwaukee, Wisconsin, United States
Stanford University
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Palo Alto, California, United States
Thomas Jefferson University
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New York, New York, United States