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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout study participation, up to 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study participation, up to 12 months.
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer cells show CD123 presence.I have been diagnosed with a specific blood cancer type.I am 18 or older, can give consent, and will follow the study rules.I have not been treated with anti-CD123 drugs, except if I have BPDCN and received tagraxofusp.I haven't taken any cancer drugs, steroids, or immune suppressants in the last 14 days.My cancer has spread to my brain or spinal cord.I haven't had a live virus vaccine in the last 4 weeks, except for flu or COVID-19 shots.My blood tests and heart function are within normal ranges.I can take care of myself and am up and about more than half of my waking hours.I agree to use effective birth control during and for 4 months after the study.My condition did not improve after at least one treatment and there are no cure options left.My side effects from previous treatments are mild.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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