What side effects are associated with this type of intervention?

Common treatments for B-Cell Leukemia, such as monoclonal antibodies (e.g., rituximab, ofatumumab) and targeted therapies, often result in side effects like infusion reactions, which can be severe, especially during the first cycle. These reactions include fever, chills, and hypotension. Chemotherapy agents used in combination, such as bendamustine, can cause additional side effects like nausea, fatigue, and hematologic toxicities (e.g., neutropenia, thrombocytopenia). Targeted therapies may also lead to specific toxicities such as hypertension, atrial fibrillation, and infections. Patients are monitored closely to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of B-Cell Leukemia. Notable among these are monoclonal antibodies such as rituximab, ofatumumab, and obinutuzumab, which target the CD20 antigen on B-cells. Additionally, idelalisib, a PI3K inhibitor, has been approved for use in combination with rituximab. These therapies are designed to target specific pathways involved in the proliferation and survival of malignant B-cells, similar to the approach being studied with MGD024.

What other types of research exist?

Promising alternatives to MGD024 for B-Cell Leukemia patients include BTK inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib, which have shown high response rates and improved progression-free survival. Venetoclax, a BCL2 inhibitor, combined with obinutuzumab, is another effective option, particularly for achieving undetectable minimal residual disease (MRD). These therapies are supported by robust clinical trial data and offer targeted treatment approaches for B-Cell Leukemia.

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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

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

Must not have

Known involvement of central nervous system (CNS) by the disease under investigation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study participation, up to 12 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called MGD024 in patients with certain blood cancers that haven't responded to other treatments. Researchers want to see if MGD024 is safe, how it works in the body, and if it helps fight cancer. Patients will receive the drug periodically, and their response will be monitored regularly.

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or spinal cord.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Complete response rate

Mean area under the concentration-time curve (AUC)

Mean maximum concentration

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for B-Cell Leukemia, such as ibrutinib, idelalisib, and rituximab, work by targeting specific pathways and proteins critical for the survival and proliferation of cancerous B-cells. Ibrutinib inhibits Bruton's tyrosine kinase (BTK), disrupting B-cell receptor signaling and leading to cancer cell death. Idelalisib targets the PI3K delta pathway, which is crucial for B-cell growth and survival. Rituximab is an anti-CD20 monoclonal antibody that induces cell death by binding to the CD20 protein on the surface of B-cells. These targeted therapies are significant for B-Cell Leukemia patients as they offer more precise treatment options with potentially fewer side effects compared to traditional chemotherapy. MGD024, being studied in clinical trials, likely represents a novel therapeutic agent that targets specific pathways in blood cancers, offering hope for improved outcomes in relapsed or refractory cases.

Selinexor (KTP-330) - a selective inhibitor of nuclear export (SINE): anti-tumor activity in diffuse large B-cell lymphoma (DLBCL).B-cell receptor pathway modulators in NHL.A critical appraisal of ibrutinib in the treatment of mantle cell lymphoma and chronic lymphocytic leukemia.