Trials / Terminated
TerminatedNCT05223699
Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB)
A Phase I/II, Dose-Escalation Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Magenta Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This research study is designed to selectively deplete CD117-positive cells from participants with AML and MDS-EB.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MGTA-117 | MGTA-117 will be administered as an IV infusion |
Timeline
- Start date
- 2022-02-14
- Primary completion
- 2023-02-02
- Completion
- 2023-02-02
- First posted
- 2022-02-04
- Last updated
- 2023-02-09
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05223699. Inclusion in this directory is not an endorsement.