Clinical trial · Interventional
A Study of Zilovertamab and Ibrutinib in Patients With Relapsed or Refractory Mantle Cell Lymphoma
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Zilovertamab (an ROR1 Antibody) Plus Ibrutinib Versus Ibrutinib Plus Placebo in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to a strategic reprioritization based on the rapidly changing clinical and commercial landscape for Bruton's tyrosine kinase inhibitors (BTK inhibitors)
Summary
Brief summary (as posted)
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).
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immune System Diseases | — | UNRESOLVED | — |
| Immunoproliferative Disorders | — | UNRESOLVED | — |
| Lymphatic Diseases | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorders | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Zilovertamab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Oral Ibrutinib
- description
- Open Label Ibrutinib Monotherapy Phase (16 weeks)
- interventionNames
- Drug: Ibrutinib
- type
- EXPERIMENTAL
- label
- Arm A: IV Infusion of Ziloveramab and Oral Ibrutinib
- description
- Randomized, Double-Blind Treatment Phase
- interventionNames
- Drug: Zilovertamab
- Drug: Ibrutinib
- type
- PLACEBO_COMPARATOR
- label
- Arm B: IV Infusion of Placebo and Oral Ibrutinib
- description
- Randomized, Double-Blind Treatment Phase
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDCheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800. PMID 25113753