Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05362773

A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies

A Phase 1, First-in-Human, Dose Escalation Study of MGD024, a CD123 x CD3 Bispecific DART Molecule, in Patients With Select Relapsed or Refractory Hematologic Malignancies

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
130 (estimated)
Sponsor
MacroGenics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in participants with select blood cancers that have not responded to treatment with standard therapies or who have relapsed after treatment. The study is designed to determine the safety, tolerability, pharmacokinetics (affect of the body on the drug), pharmacodynamic (affect of the drug on the body), immunogenicity (development of antibodies against the drug), and preliminary anti-cancer effect of MGD024. Participants will receive treatment with MGD024 in consecutive 28-day cycles for a study treatment period of up to 12 cycles (approximately 1 year) or until treatment or study discontinuation criteria are met. Response assessments will be performed after Cycle 1 and then after every even numbered cycle starting with Cycle 2 until progression or study treatment discontinuation. Participants will be checked for side effects throughout the study.

Conditions

Interventions

TypeNameDescription
DRUGMGD024MGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes.

Timeline

Start date
2022-07-13
Primary completion
2026-11-01
Completion
2027-05-01
First posted
2022-05-05
Last updated
2026-01-13

Locations

7 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05362773. Inclusion in this directory is not an endorsement.