drugset / Trial / NCT03088878
A Study of Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies
Phase 1/2
Completed
95 enrolled
Oncternal Therapeutics, Inc
California Institute for Regenerative Medicine (CIRM) · collabPharmacyclics LLC. · collabUniversity of California, San Diego · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is Phase 1b/2 study to investigate the safety and effectiveness of the investigational drug, cirmtuzumab, when given in combination with ibrutinib in patients with B-cell lymphoid malignancies. Cirmtuzumab is a monoclonal antibody that attaches to a protein (called ROR 1) that is found on hematologic tumor cells. ROR1 has been shown to play a role in cell signaling that cause leukemia and lymphoma cells to grow and survive. ROR1 is rarely found on healthy cells.
Timeline
- Start
- 2018-01-03
- Primary completion
- 2024-09-25
- Completion
- 2024-09-25
Publications
- Background Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.
- Background Cheson 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.
- Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cirmtuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Cirmtuzumab | Monoclonal antibody | 16 mg/kg | Intravenous |
| Subject | Cirmtuzumab | Monoclonal antibody | 300 mg | Intravenous |
| Subject | Cirmtuzumab | Monoclonal antibody | 600 mg | Intravenous |
| Comparator | Ibrutinib | Small molecule | 420 mg | Oral |
| Comparator | Ibrutinib | Small molecule | 560 mg | Oral |