A Study of Zilovertamab and Ibrutinib in Patients With Relapsed or Refractory Mantle Cell Lymphoma

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3 study to investigate the safety and efficacy of the investigational drug, zilovertamab, when given in combination with ibrutinib in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncternal Therapeutics, Inc
• Collaborator: Pharmacyclics LLC.

Criteria

Inclusion Criteria:

• Histologically confirmed MCL

• Has received one prior regimen for MCL

• Disease is relapsed or refractory

• At least 1 measurable site of disease that is ≥ 2.0 cm

• PET-CT performed less than 28 days before study entry

• If a subject has toxicities due to prior therapy for the treatment of MCL, must be stable and recovered

• Eastern Cooperative Oncology Group performance status of 0 or 1.

• Study-specific laboratory parameters must be met

• Females of childbearing potential and males must use highly effective contraception

Exclusion Criteria:

• Received more than one month of prior therapy with ibrutinib or any other Bruton's tyrosine kinase inhibitor

• Concurrent enrollment in another investigational study

• Transfusion-dependent thrombocytopenia

• Anticancer therapy within 25 days before the start of the study

• History of other malignancy, cancer, or carcinoma for at least three years before the start of the study

• Central nervous system (CNS) involvement with lymphoma

• CNS disorder ≤ 6 months of study entry

• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmias, class 3 or 4 congestive heart failure, or other clinically significant cardiac disease ≤ 6 months of study entry

• Active or prior cardiac (atrial or ventricular) lymphoma involvement

• History of atrial fibrillation or left or right bundle branch block

• History of symptomatic deep vein thrombosis or pulmonary embolism ≤ 6 months of study entry

• Chronic liver disease with hepatic impairment, Child-Pugh class B or C

• Bleeding disorder

• Prior stem cell transplant that requires ongoing immunosuppressive therapy or active clinical graft versus host disease

• Primary severe immunodeficiency

• Human immunodeficiency virus infection (HIV) or active hepatitis B or C infection

• Active infection requiring IV antimicrobial (antiviral, antibiotic, anti-fungal) therapy at the time of study entry

• Vaccination with a live, attenuated vaccine ≤ 4 weeks of the start of the study

• Hypersensitivity reaction to any of the agents used in this study

• Requires treatment with a strong cytochrome P450 enzyme (CYP) 3A (CYP3A) inhibitor/inducer.

• Unable or swallow capsules or tablets or has malabsorption syndrome or disease affecting gastrointestinal function

• Major surgery ≤ 4 weeks of study start

• Medical condition likely to interfere with assessment of safety or efficacy of the study drug

• Not eligible in the opinion of the Investigator

• Pregnant or breastfeeding

Other protocol-defined inclusion/exclusion criteria will apply.