Overview

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.