Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Duvortuxizumab (JNJ-64052781) Plus Ibrutinib in Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
About this trial
This is an interventional treatment trial for Leukemia, Lymphocytic, Chronic, B-Cell focused on measuring B-Cell, Malignancy, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphocytic, Chronic, B-Cell, JNJ-64052781, Ibrutinib
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Dose Optimization:Participant with Certain B-Cell Malignancies
Dose Expansion: Participants with DLBCL
Dose Expansion: Participants with FL
Dose Expansion: Participants with MCL
Dose Expansion: Participants with CLL
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.
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.
Participants with FL 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.
Participants with MCL 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.
Participants with chronic lymphocytic leukemia (CLL) 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.