What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia (AML), including bispecific antibodies like Vibecotamab, often have side effects such as neutropenia, which increases the risk of infections, and other hematologic toxicities like anemia and thrombocytopenia. Chemotherapy regimens, such as those involving cytarabine and daunorubicin, can cause gastrointestinal issues, mucositis, and alopecia. Monoclonal antibodies and targeted therapies may also lead to infusion-related reactions, liver toxicity, and skin rashes. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Myeloid Leukemia (AML), including targeted therapies and immunotherapies. Notably, gemtuzumab ozogamicin, a CD33-targeting antibody-drug conjugate, has been approved for CD33-positive AML. Additionally, venetoclax, a BCL-2 inhibitor, and ivosidenib, an IDH1 inhibitor, have shown efficacy in combination with hypomethylating agents (HMAs) like azacitidine and decitabine. While specific bispecific antibodies like Vibecotamab (CD3-CD123) are still under investigation, these approved therapies highlight the evolving landscape of AML treatment, focusing on targeted and combination approaches.

What other types of research exist?

Promising novel alternatives to Vibecotamab for AML patients include: 1) Venetoclax in combination with hypomethylating agents or low-dose cytarabine, which has shown high response rates in elderly or unfit patients. 2) FLT3 inhibitors like Gilteritinib for patients with FLT3 mutations, which have demonstrated improved survival rates. 3) CPX-351 (liposomal daunorubicin and cytarabine) for secondary AML, which has shown better outcomes compared to traditional chemotherapy. 4) Immune checkpoint inhibitors such as Nivolumab or Pembrolizumab, which are being explored in combination with other agents for their potential to enhance anti-leukemic immune responses.

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Monoclonal Antibodies

Vibecotamab for Acute Myeloid Leukemia

Phase 2

Recruiting

Led By Nicholas Short, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance status 2 (ECOG Scale)

Male patients and their female partner of childbearing potential must agree to use highly effective contraception, as above, and refrain from donating sperm during the treatment period and for at least 4 weeks after the last dose of vibecotamab

Must not have

Treatment with any antileukemic agents or chemotherapy agents in the last 7 days or 5 half-lives before study entry

Patients who are expected to be able to proceed with stem cell transplantation within the next 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing vibecotamab, a medicine that helps the immune system target cancer cells, in patients with AML or MDS who haven't responded to standard treatments. It works by connecting immune cells to cancer cells, making it easier for the immune system to attack the cancer.

Who is the study for?

Adults over 18 with Acute Myeloid Leukemia (AML) in remission but still showing signs of disease, or Myelodysplastic Syndrome (MDS) unresponsive to prior treatments. Participants must have a certain level of CD123 expression on cancer cells and be able to perform daily activities with some limitations. Women who can bear children and men must use effective birth control.

What is being tested?

The trial is testing vibecotamab, an antibody targeting leukemia cells, along with supportive medications like dexamethasone, acetaminophen, and diphenhydramine for safety and effectiveness in AML patients with residual disease and MDS patients after treatment failure.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to the drug, such as fever or chills during infusion. Other common side effects may involve fatigue, headache, nausea, or allergic reactions due to the medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk and care for myself but cannot do any physical work.

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My partner and I agree to use effective birth control and I won't donate sperm while on vibecotamab and for 4 weeks after.

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My leukemia cells show at least 20% CD123 expression.

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I am 18 years old or older.

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My AML is in remission after intensive chemotherapy.

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My MDS is high risk and didn't improve after 4+ cycles of specific treatments.

Exclusion Criteria

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

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I haven't taken any cancer medication in the last 7 days or 5 half-lives.

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I am expected to undergo a stem cell transplant within the next 30 days.

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I do not have severe liver, kidney, heart problems, or uncontrolled infections.

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I have previously been treated with vibecotamab or anti-CD123 therapy.

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I have HIV with a detectable viral load.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: MDS post-HMA failure cohort onlyExperimental Treatment4 Interventions

Each study cycle is 28 days. Vibecotamab by vein (IV) over about 2 hours On Days 1, 3, 5, 8, 15 and 22 of Cycle 1 and then on Days 1, 8, 15 and 22 of Cycles 2-4.

Group II: AML MRD cohort onlyExperimental Treatment4 Interventions

Each study cycle is 28 days. Vibecotamab by vein (IV) over about 2 hours On Days 1, 3, 5, 8, 15 and 22 of Cycle 1 and then on Days 1, 8, 15 and 22 of Cycles 2-4.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetaminophen

2017

Completed Phase 4

~2030

Diphenhydramine

2002

Completed Phase 4

~1210

Dexamethasone

2007

Completed Phase 4

~2650

0 / 11Eligibility 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 Acute Myeloid Leukemia (AML) include intensive combination chemotherapy, targeted therapies, and immunotherapies. Chemotherapy aims to kill rapidly dividing cells, including cancer cells, but often comes with significant side effects. Targeted therapies focus on specific genetic mutations or proteins involved in AML, offering a more precise approach with potentially fewer side effects. Immunotherapies, such as bispecific antibodies like Vibecotamab, engage the patient's immune system to recognize and kill AML cells. Vibecotamab specifically targets CD123 on AML cells and CD3 on T-cells, bringing them into close proximity to facilitate the immune-mediated destruction of the cancer cells. This mechanism is crucial for AML patients as it offers a novel approach to treatment, especially for those who have not responded to conventional therapies.

CD123-targeted therapy in acute myeloid leukemia.Harnessing T Cells to Target Pediatric Acute Myeloid Leukemia: CARs, BiTEs, and Beyond.