Clinical trial · Interventional
Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Duvortuxizumab (JNJ-64052781) Plus Ibrutinib in Lymphoma
A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of the Combination of Duvortuxizumab With Ibrutinib in Subjects With B-Cell Malignancies
NCT02743546CI-TRIAL-00085421withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether duvortuxizumab and ibrutinib can be combined safely and to establish the maximum tolerated dose (MTD) in Part 1 and the recommended Phase 2 dose (RP2D) and to further explore the safety of duvortuxizumab in combination with ibrutinib at the RP2D in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) in Part 2.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duvortuxizumab | Drug | — | UNRESOLVED |
| Ibrutinib | Drug | Ibrutinib | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Dose Optimization:Participant with Certain B-Cell Malignancies
- description
- Participants with certain B-cell malignancies (diffuse large B-cell lymphoma \[DLBCL\], mantle cell lymphoma \[MCL\], or follicular lymphoma \[FL\]) will receive rising doses of intravenous infusions of duvortuxizumab either with or without a priming dose in combination with oral ibrutinib until disease progression, unacceptable toxicity, or other protocol-specified withdrawal criteria are met. Dose escalation will continue until the recommended phase 2 dose or maximum tolerated dose is reached.
- interventionNames
- Drug: Duvortuxizumab
- Drug: Ibrutinib
- type
- EXPERIMENTAL
- label
- Dose Expansion: Participants with DLBCL
- description
- Participants with DLBCL will receive intravenous infusions of duvortuxizumab either with or without a priming dose in combination with oral ibrutinib at the recommended phase 2 dose until disease progression, unacceptable toxicity, or other protocol-specified withdrawal criteria are met.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The participant has a B-cell malignancy (diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], mantle cell lymphoma \[MCL\], or chronic lymphocytic leukemia \[CLL\]) with tumor progression following at least one (MCL and CLL) or two (DLBCL and FL) prior standard therapies * The participant has a radiographically measurable tumor that requires treatment according to the treating physician * The participant is able to carry out daily life activities with significant difficulty * The participant has adequate organ and blood cell counts * Sexually active participants must use medically acceptable methods of contraception during the course of the study Exclusion Criteria: * The participant has a brain tumor or significant side effects, including severe neurological side effects, from a previous anti-cancer treatment * Current severe, uncontrolled systemic disease including an ongoing, active infection or history of clinically significant heart problems * History of autoimmune disease, allogeneic hematopoietic stem cell transplant, or organ transplant * The participant has received any of the following: ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitor at any time; an agent targeting CD19-positive cells or CD3-expressing T cells at any time; or warfarin, a vitamin K antagonist, or a blood transfusion (red blood cells and/or platelets) within 1 week of starting the study * The participant is pregnant, breastfeeding, or planning to become pregnant or father a child
References
Publications (0)
Data not yet available
No reference posted for this study.