Trial Title:
A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia
NCT ID:
NCT05886491
Condition:
Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
Drug Therapy
AML
acute myeloid leukemia
cell therapy
allogenic
gamma delta T cells
relapsed/ refractory
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GDX012
Description:
GDX012 suspension for IV infusion.
Arm group label:
Phase 1: Dose Escalation of GDX012
Arm group label:
Phase 2a: GDX012
Intervention type:
Drug
Intervention name:
Chemotherapy Agents
Description:
Chemotherapy agents (fludarabine/cyclophosphamide) as per standard of care.
Arm group label:
Phase 1: Dose Escalation of GDX012
Arm group label:
Phase 2a: GDX012
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham (UAB) Hospital
Address:
City:
Birmingham
Zip:
35205-5802
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
205-996-4093
Email:
mgutarra@uabmc.edu
Investigator:
Last name:
Manuel Espinoza-Gutarra
Email:
Principal Investigator
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010-3012
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
626-218-2405
Email:
malmalki@coh.org
Investigator:
Last name:
MONZR AL MALKI
Email:
Principal Investigator
Facility:
Name:
Stanford University
Address:
City:
Palo Alto
Zip:
94304-1812
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
650-353-6404
Email:
alice1@stanford.edu
Investigator:
Last name:
Alice Bertaina
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon/CBCI
Address:
City:
Denver
Zip:
80218-1258
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
720-754-4800
Email:
Alireza.Eghtedar@hcahealthcare.com
Investigator:
Last name:
Alireza Eghtedar
Email:
Principal Investigator
Facility:
Name:
Comprehensive Cancer Center of Northwestern University
Address:
City:
Chicago
Zip:
60611-3124
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
312-503-1817
Email:
j-altman@northwestern.edu
Investigator:
Last name:
Jessica Altman
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
617-632-1906
Email:
evan_chen@dfci.harvard.edu
Investigator:
Last name:
Evan CHEN
Email:
Principal Investigator
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110-1010
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
314-455-8317
Email:
jdipersi@wustl.edu
Investigator:
Last name:
John DiPersio
Email:
Principal Investigator
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14263-0001
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
716-845-3544
Email:
eunice.wang@roswellpark.org
Investigator:
Last name:
Eunice Wang
Email:
Principal Investigator
Facility:
Name:
Thomas Jefferson University
Address:
City:
New York
Zip:
10065-4870
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
215-955-4367
Email:
usama.gergis@jefferson.edu
Investigator:
Last name:
Usama Gergis
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195-0001
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
216-444-2200
Email:
mustafm8@ccf.org
Investigator:
Last name:
Moaath Mustafa Ali
Email:
Principal Investigator
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239-3011
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
503-494-5566
Email:
saultzje@ohsu.edu
Investigator:
Last name:
Jennifer Saultz
Email:
Principal Investigator
Facility:
Name:
Tri-Star BMT/Sarah Cannon Nashville
Address:
City:
Nashville
Zip:
37203-6521
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
615-342-7440
Email:
Stephen.Strickland@hcahealthcare.com
Investigator:
Last name:
Stephen Strickland
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
713-563-1487
Email:
amaiti@mdanderson.org
Investigator:
Last name:
Abhishek Maiti
Email:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226-3522
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
414-805-8753
Email:
kabarker@mcw.edu
Investigator:
Last name:
Karen Carlson
Email:
Principal Investigator
Start date:
July 11, 2023
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Takeda
Agency class:
Industry
Source:
Takeda
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05886491
