A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies (NCT05362773) | Clinical Trial Compass
RecruitingPhase 1
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
United States130 participantsStarted 2022-07-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.
* Participants with
* primary or secondary acute myeloid leukemia (AML) except acute promyelocytic leukemia,
* primary or secondary myelodysplastic syndrome (MDS) with prognostic score of \>3 and \<20% bone marrow blasts,
* 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.
* Evidence of at least 20% of malignant cells with CD123 expression.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
* Life expectancy of at least 12 weeks.
* Acceptable laboratory values, and heart function.
* Continuing side effects of prior treatment are mild
* Women and men of childbearing potential must agree to use highly effective forms of contraception throughout the study through 4 months after the last dose of MGD024.
Exclusion Criteria:
* Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp).
* Known involvement of central nervous system (CNS) by the disease under investigation.
* History or current evidence of any con…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of severe side effects in patients receiving MGD024
Timeframe: First 28 days of the study
2
Number and types of adverse events (AEs), including serious adverse events (SAEs), and AEs leading to treatment discontinuation.
Timeframe: Throughout study participation, up to 12 months.