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Monoclonal Antibodies

MGD024 for Blood Cancers

Phase 1
Recruiting
Research Sponsored by MacroGenics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures
Patients with primary or secondary acute myeloid leukemia (AML), primary or secondary myelodysplastic syndrome (MDS), classical Hodgkin lymphoma (cHL), chronic myelogenous leukemia (CML), b-cell acute lymphocytic leukemia (B-ALL), hariy cell leukemia (HCL), advanced systemic mastocytosis (ASM), or blastic plasmacytoid dendritic cell neoplasm (BPDCM)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study participation, up to 12 months.
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new drug, MGD024, for blood cancers that have not responded to standard therapies or have relapsed after treatment. The study will last up to 1 year, and patients will be checked for side effects and response to treatment throughout.

Who is the study for?
This trial is for adults over 18 with certain blood cancers like AML, MDS, Hodgkin's lymphoma, and others who've had no luck with standard treatments or have seen their cancer return. They must be able to consent, follow study rules, have a life expectancy of at least 12 weeks, decent lab results and heart function. Participants need to use effective birth control and can't join if they've had CNS disease involvement or recent other treatments.Check my eligibility
What is being tested?
MGD024 is being tested in patients with specific relapsed or treatment-resistant blood cancers. The study aims to evaluate the drug's safety, how it affects and is processed by the body, whether it triggers immune responses (like antibodies), and its initial effectiveness against cancer over up to one year of treatment cycles.See study design
What are the potential side effects?
While not explicitly listed here, side effects are monitored throughout the trial. Common side effects for similar therapies may include reactions at injection sites, fatigue, fever-like symptoms due to immune response activation; organ-specific inflammation; changes in blood counts leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older, can give consent, and will follow the study rules.
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I have been diagnosed with a specific blood cancer type.
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My condition did not improve after at least one treatment and there are no cure options left.
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My cancer cells show CD123 presence.
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I can take care of myself and am up and about more than half of my waking hours.
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My blood tests and heart function are within normal ranges.
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My side effects from previous treatments are mild.
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I agree to use effective birth control during and for 4 months after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study participation, up to 12 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study participation, up to 12 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and types of adverse events (AEs), including serious adverse events (SAEs), and AEs leading to treatment discontinuation.
Number of severe side effects in patients receiving MGD024
Secondary outcome measures
Anti-drug antibody formation
Area under the concentration-time curve (AUC)
Complete response rate
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment1 Intervention
Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level.

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor
48 Previous Clinical Trials
5,286 Total Patients Enrolled
Ashley Ward, M.D.Study DirectorMacroGenics
2 Previous Clinical Trials
525 Total Patients Enrolled

Media Library

MGD024 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05362773 — Phase 1
B-Cell Leukemia Research Study Groups: Dose Escalation
B-Cell Leukemia Clinical Trial 2023: MGD024 Highlights & Side Effects. Trial Name: NCT05362773 — Phase 1
MGD024 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05362773 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this investigation open to participants?

"Affirmative. Clinicaltrials.gov reveals that this research project, initially posted on July 13th 2022, is actively recruiting participants at the moment. Approximately 90 patients must be enrolled from 5 distinct medical facilities."

Answered by AI

What is the current size of the patient population taking part in this clinical trial?

"To successfully conclude this medical trial, 90 qualified patients must be recruited to participate. Medical centres in Durham and Grand Rapids are both accepting participants for the study."

Answered by AI

How many locations are actively participating in this experiment?

"There are 5 clinical trial sites currently enrolling patients, including Duke University Medical Center in Durham, South Texas Accelerated Research Therapeutics, LLC - Midwest in Grand Rapids and South Austin Medical Centre in Austin. In addition to these three locations there are other medical centres actively signing up participants."

Answered by AI

Has the FDA sanctioned MGD024 for use?

"Since this is an early phase trial, there are only limited confirmations of efficacy and safety. Consequently, MGD024 was rated a score of 1 on our scale."

Answered by AI
~29 spots leftby Mar 2025