Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2023-02-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research study is designed to selectively deplete CD117-positive cells from participants with AML and MDS-EB.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT01238211

Acute Myeloid Leukemia Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 +5 more

COMPLETED PHASE2

Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)

NCT03552029

Acute Myeloid Leukemia

TERMINATED PHASE1

Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia

NCT02003222

Acute Lymphoblastic Leukemia B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

ACTIVE_NOT_RECRUITING PHASE3

Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS

NCT05829434

Acute Myeloid Leukemia Myelodysplastic Neoplasm

WITHDRAWN PHASE2

Blinatumomab Intensification for MRD-Negative Acute B-Cell Lymphoblastic Leukemia Before Allogeneic Hematopoietic Stem Cell Transplantation

NCT07003737

Acute Lymphoblastic Leukemia, B-precursor

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential anti-leukemia activity and to establish the minimum safe and biologically-effective dose of a single dose of MGTA-117 in relapsed/refractory (R/R) CD117+ AML participants and participants with MDS-EB. The study consists of escalating single-dose cohorts using a standard 3+3 design.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myeloid Leukemia Myelodysplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single dose MGTA-117

Dosing of MGTA-117 prepared and administered by IV infusion.

Group Type EXPERIMENTAL

MGTA-117

Intervention Type BIOLOGICAL

MGTA-117 will be administered as an IV infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MGTA-117

MGTA-117 will be administered as an IV infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participant must have a World Health Organization (WHO)-defined diagnosis of R/R AML and meet one of the following criteria:

\- The participant has experienced primary AML induction failure or R/R AML

OR

\- The participant has a WHO-defined diagnosis of MDS-EB and has failed/is refractory to HMA

OR

\- Presence of MRD in morphologic CR
2. CD117+ based on IHC or flow cytometry
3. Participant must have an identified HSC donor (related donor or unrelated donor), haplo-identical transplant donor, or umbilical blood donor.
4. Participant's Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2.
5. Participant must have adequate baseline hepatic function. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤2 x upper limit of normal (ULN), and serum bilirubin ≤1.5 x ULN.
6. Estimated creatinine clearance ≥60 mL/min
7. Adequate cardiac function as demonstrated by cardiac left ventricular ejection fraction ≥40% or perform New York Heart Association (NYHA) classification I and II

Exclusion Criteria

1. Acute promyelocytic leukemia (APL).
2. Known active central nervous system (CNS) leukemia or chloroma (granulocyte sarcoma).
3. Received HSCT within 6 months prior to dosing
4. Received chimeric antigen-receptor cell therapies within 6 months prior to dosing
5. Has active graft-versus-host disease (GVHD).
6. Active hepatitis B (Hep-B) or hepatitis C (Hep-C) infection or history of human immunodeficiency virus (HIV).
7. Participant with a QTc value \>470 msec
8. Participant has received another investigational drug or device within 14 days or 5 half-lives of dosing, whichever is longer.
9. Participant has any clinically significant medical condition, which in the opinion of the Investigator may place the participant at an unacceptable risk.
10. Active uncontrolled systemic bacterial, fungal, or viral infection
11. Participant has a history of serious allergic reactions, which in the opinion of the Investigator may pose an increased risk of serious infusion reactions.
12. Participant has had any systemic antileukemia treatment within 14 days except hydroxyurea, which is permitted until 24 hours prior to MGTA-117 dosing.
13. Participant has received prior anti-CD117 antibody treatment.
14. Participant has received gemtuzumab ozogamicin (Mylotarg) within the last 3 months prior to dosing.
15. Participant has received recent monoclonal antibody as anti-leukemic therapy within the last 30 days or 5 half-lives, whichever is longer.
16. Participant has received recent vaccination within the last 14 days prior to dosing.
17. Participant has Grade 2 or higher electrolyte abnormality at screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No