Ocrevus (ocrelizumab)

P4, N=800, Active, not recruiting, The Cleveland Clinic | Recruiting --> Active, not recruiting

Historically, B and T cell (B-T cell) co-interaction was targeted through different pathways such as alemtuzumab, abatacept, and dapirolizumab with variable impact on B cell depletion (BCD), whereas the majority of patients with AID including rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis and organ transplantation benefit from targeted BCD with anti-CD20 monoclonal antibodies such as rituximab, ocrelizumab or ofatumumab...In the treatment of cancer, chimeric antigen receptor (CAR) T cell therapy and T cell engagers (TCE) that recruit T cells to induce B cell cytotoxicity have delivered promising results for anti-CD19 CAR T cell therapies, the CD19 TCE blinatumomab and CD20 TCE such as mosunetuzumab, glofitamab or epcoritamab. Limited evidence suggests that anti-CD19 CAR T cell therapy may be effective in managing refractory AID whereas we await evaluation of TCE for use in non-oncological indications. Therefore, here, we discuss the potential mechanistic advantages of novel therapies that rely on T cells as effector cells to disrupt B-T cell collaboration toward overcoming rituximab-resistant AID.

P1, N=134, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Jan 2023 --> Jun 2025

P=N/A, N=732, Active, not recruiting, State University of New York at Buffalo | Trial primary completion date: Mar 2024 --> Jun 2024

P=N/A, N=732, Active, not recruiting, State University of New York at Buffalo | Trial primary completion date: Mar 2024 --> Nov 2024

P3, N=1500, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Mar 2025 --> Sep 2025

P4, N=179, Active, not recruiting, Genentech, Inc. | Trial primary completion date: Dec 2022 --> Dec 2025

P3, N=236, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Mar 2023 --> Apr 2025

P=N/A, N=14, Active, not recruiting, Providence Health & Services | Trial completion date: Aug 2023 --> Dec 2024 | Trial primary completion date: Aug 2023 --> Dec 2024

P4, N=44, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting

P3, N=769, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Jul 2029 --> Mar 2029 | Trial primary completion date: Nov 2025 --> Apr 2025

P3, N=19, Completed, Providence Health & Services | Active, not recruiting --> Completed | N=52 --> 19

P2, N=220, Completed, Genentech, Inc. | Active, not recruiting --> Completed

P4, N=179, Active, not recruiting, Genentech, Inc. | Trial completion date: Aug 2025 --> Dec 2025

P=N/A, N=60, Recruiting, Kessler Foundation | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

P4, N=20, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting

P1/2, N=40, Recruiting, The Methodist Hospital Research Institute | Unknown status --> Recruiting

P=N/A, N=24, Completed, University of Maryland, Baltimore | Active, not recruiting --> Completed

P=N/A, N=150, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting

P4, N=0, Withdrawn, Hoffmann-La Roche | N=50 --> 0 | Not yet recruiting --> Withdrawn

P3, N=1500, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting

P4, N=44, Recruiting, Hoffmann-La Roche | Trial completion date: Jan 2025 --> Apr 2025 | Trial primary completion date: Feb 2024 --> May 2024

P3, N=770, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting

P4, N=20, Recruiting, Hoffmann-La Roche | Trial completion date: Oct 2024 --> Jan 2025

P2, N=36, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting

P4, N=10, Active, not recruiting, Johns Hopkins University | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P=N/A, N=25, Completed, Johns Hopkins University | Active, not recruiting --> Completed

P3, N=699, Recruiting, Hoffmann-La Roche | Active, not recruiting --> Recruiting

P4, N=20, Recruiting, Hoffmann-La Roche | Trial primary completion date: Nov 2023 --> Mar 2024

P3, N=1500, Recruiting, Hoffmann-La Roche | Active, not recruiting --> Recruiting | Phase classification: P3b/4 --> P3

P=N/A, N=64, Completed, NYU Langone Health | Active, not recruiting --> Completed | Trial completion date: Oct 2023 --> Apr 2023

P=N/A, N=150, Not yet recruiting, Novartis Pharmaceuticals

Women with MS have lower all-cause survival after breast cancer diagnosis than women without MS. Hence it is important to identify any risk factors or therapies that might be associated with increased risk of cancer.

P3, N=233, Recruiting, Hoffmann-La Roche | Trial completion date: Nov 2025 --> Sep 2029

P=N/A, N=60, Recruiting, Kessler Foundation | Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023

P3, N=1239, Completed, Hoffmann-La Roche | Trial primary completion date: Aug 2022 --> Apr 2023

P=N/A, N=1178, Recruiting, Biogen | N=825 --> 1178

P=N/A, N=732, Active, not recruiting, State University of New York at Buffalo | Not yet recruiting --> Active, not recruiting

P=N/A, N=732, Active, not recruiting, State University of New York at Buffalo | Not yet recruiting --> Active, not recruiting

P3, N=1300, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting

Samples that tested positive in the screening assay were subsequently analyzed in the confirmatory assay where another anti-CD20 mAb, obinutuzumab, was replaced by ocrelizumab, to verify NAb specificity. Our validated NAb assay showed a relative sensitivity of 743 ng/mL and can detect 1500 ng/mL of a surrogate positive control antibody in the presence of 1500 ng/mL ocrelizumab. This ADCC assay is the first reported NAb assay that directly measures target cell lysis by using thaw-and-use target and effector cells simultaneously.

P3, N=594, Recruiting, Rigshospitalet, Denmark | Trial completion date: Apr 2028 --> Dec 2028 | Trial primary completion date: Apr 2025 --> Dec 2025