What side effects are associated with this type of intervention?

Common treatments for Acute Lymphoblastic Leukemia (ALL), particularly those targeting CD123, such as cytarabine-based regimens, often result in side effects like severe or life-threatening cytopenias, hypersensitivity reactions, serious infections, and prolonged hypogammaglobulinemia. Other adverse events include prolonged cytopenias, second malignancies, and treatment-related deaths. Additionally, treatments like clofarabine can cause moderate but acceptable toxicity, including hypersensitivity reactions and serious infections.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for Acute Lymphoblastic Leukemia (ALL). Blinatumomab, a CD3/CD19-directed bispecific T-cell engager, is approved for relapsed or refractory B-cell precursor ALL. Additionally, tyrosine kinase inhibitors like imatinib and dasatinib are approved for Philadelphia chromosome-positive ALL. These treatments, while not targeting CD123 specifically, represent the class of targeted therapies similar to VIP943, which is under investigation for its efficacy in CD123+ hematologic malignancies.

What other types of research exist?

Promising alternatives to VIP943 for Acute Lymphoblastic Leukemia (ALL) patients include: 1) AMG 553, a chimeric antigen receptor (CAR) T-cell therapy targeting FLT3, which has shown targeted cytotoxicity against AML cells and may be applicable to ALL. 2) OP-5244, a small-molecule CD73 inhibitor that reverses immunosuppression and has shown efficacy in preclinical studies. 3) PF-06342674, a humanized monoclonal antibody against IL-7 receptor-α, which modulates immune activity and has shown potential in type 1 diabetes but may be relevant for ALL due to its immunomodulatory effects.

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Monoclonal Antibodies

VIP943 for Blood Cancers

Phase 1

Recruiting

Research Sponsored by Vincerx Pharma, Inc.

Eligibility Criteria Checklist

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

Must have

Evidence of CD123 expression from a local laboratory.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Must not have

Clinically significant cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose.

Known central nervous system (CNS) metastases and/or carcinomatous meningitis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing VIP943, a new drug, to find the safest and most effective dose for patients with advanced blood cancers who have no other treatment options. The drug works by targeting a protein on cancer cells to help kill them or stop their growth.

Who is the study for?

This trial is for people with advanced blood cancers like leukemia, who have a specific marker called CD123. They should be fairly active and able to care for themselves (ECOG 0-2) and must have tried all standard treatments or can't receive them. People with brain cancer spread or serious heart problems cannot join.

What is being tested?

The study is testing VIP943's safety and finding the highest dose patients can take without severe side effects in those with CD123+ hematologic malignancies. It starts with small doses that increase until they find the right balance between effectiveness and safety.

What are the potential side effects?

Specific side effects of VIP943 are not listed, but generally, such drugs may cause fatigue, nausea, fever, bleeding risks, allergic reactions during infusion into the vein, liver issues, or impact on bone marrow function.

Eligibility Criteria

Inclusion Criteria

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

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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 leukemia or myelodysplastic syndrome has not responded to standard treatments.

Exclusion Criteria

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

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I do not have serious heart problems like recent heart attacks or severe chest pain.

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My cancer has spread to my brain or its coverings.

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: Dose Escalation of VIP943 (QW)Experimental Treatment1 Intervention

Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration weekly (QW).

Group II: Dose Escalation of VIP943 (BIW)Experimental Treatment1 Intervention

Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration twice weekly (BIW).

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

The most common treatments for Acute Lymphoblastic Leukemia (ALL) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by using cytotoxic drugs to kill rapidly dividing leukemia cells, aiming to reduce the leukemia cell population to undetectable levels. Targeted therapies, such as tyrosine kinase inhibitors (e.g., imatinib, dasatinib), specifically inhibit proteins involved in the growth and survival of leukemia cells, such as the BCR-ABL protein in Philadelphia chromosome-positive ALL. Immunotherapies, including monoclonal antibodies and CAR-T cell therapy, harness the patient's immune system to recognize and destroy leukemia cells. Treatments like VIP943, which target CD123, a marker on leukemia cells, represent a form of immunotherapy that aims to selectively eliminate malignant cells while sparing normal cells. These mechanisms are crucial for ALL patients as they offer more precise and effective ways to eradicate leukemia cells, reduce relapse rates, and improve overall survival outcomes.