^
    2d
    A Study to Evaluate ICP-022 in Patients With R/R Mantle Cell Lymphoma (MCL) (clinicaltrials.gov)
    P1/2, N=106, Completed, Beijing InnoCare Pharma Tech Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    CCND1 (Cyclin D1)
    |
    Chr t(11;14)
    |
    Inokai (orelabrutinib)
    2d
    A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies (clinicaltrials.gov)
    P1/2, N=81, Active, not recruiting, Beijing InnoCare Pharma Tech Co., Ltd. | Trial completion date: Jan 2025 --> Jun 2026 | Trial primary completion date: Dec 2023 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Inokai (orelabrutinib)
    7d
    ICP-CL-00128: A phase 3 study of orelabrutinib in combination with rituximab plus bendamustine (BR) compared with BR in subjects with treatment-na?ve mantle cell lymphoma (2025-524241-27-00)
    P2/3, N=40, Not yet recruiting, Innocare Pharma Inc.
    New P2/3 trial
    |
    CCND1 (Cyclin D1)
    |
    Rituxan (rituximab) • Inokai (orelabrutinib) • bendamustine • Truxima (rituximab-abbs)
    23d
    A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis (clinicaltrials.gov)
    P3, N=705, Recruiting, Zenas BioPharma (USA), LLC | Initiation date: Dec 2025 --> Mar 2026
    Trial initiation date
    |
    Inokai (orelabrutinib)
    27d
    CUREMZL002: A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New P2 trial
    |
    lenalidomide • Inokai (orelabrutinib) • Monjuvi (tafasitamab-cxix)
    1m
    High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia (clinicaltrials.gov)
    P3, N=86, Recruiting, Shandong University
    New P3 trial
    |
    Inokai (orelabrutinib) • dexamethasone
    1m
    Ultra-low-dose Radiation Therapy Followed by Orelabrutinib as First-line Treatment for Stage Ⅰ-Ⅱ MALT Lymphoma: A Prospective, Multicenter Phase Ⅱ Study (clinicaltrials.gov)
    P2, N=60, Recruiting, Zhejiang Cancer Hospital
    New P2 trial
    |
    Inokai (orelabrutinib)
    2ms
    Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL) (clinicaltrials.gov)
    P2, N=32, Recruiting, Sun Yat-sen University | Trial completion date: Aug 2023 --> Aug 2028 | Trial primary completion date: Aug 2023 --> Aug 2026
    Trial completion date • Trial primary completion date
    |
    Rituxan (rituximab) • Inokai (orelabrutinib)
    2ms
    Orelabrutinib combined with rituximab for the treatment of MZL with pss (ChiCTR2600121587)
    P2, N=12, The FIrst Affiliated Hospital, College of Medicine, Zhejiang University; The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
    New P2 trial
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan (rituximab) • Inokai (orelabrutinib)
    2ms
    Orelabrutinib Combined With Rituximab and Lenalidomide (OR2 Regimen) as First-line Treatment for Marginal Zone Lymphoma: a Multicenter Prospective Single Arm Trial (ChiCTR2600120773)
    P=N/A, N=36, The First Hospital of Jilin University; The First Hospital of Jilin University
    New trial
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan (rituximab) • lenalidomide • Inokai (orelabrutinib)
    2ms
    dexamethasone and orelabrutinib in newly diagnosed primary immune thrombocytopenia (ChiCTR2600120287)
    P=N/A, N=66, HenanCancerHospital; HenanCancerHospital
    New trial
    |
    Inokai (orelabrutinib) • dexamethasone
    2ms
    Orelabrutinib and rituximab regimen combined with intravitreal methotrexate for treatment of primary vitreoretinal lymphoma: a case report and literature review. (PubMed, Front Oncol)
    Although agents such as lenalidomide and Bruton's tyrosine kinase(BTK) inhibitors have demonstrated efficacy in relapsed/refractory (R/R)PVRL, their role in treatment-naïve patients remains unclear. In conclusion, the combination of Orelabrutinib, rituximab, and intravitreal MTX is a feasible therapeutic strategy for PVRL. Our findings may contribute to a potential paradigm shift in the management of this rare disease.
    Journal
    |
    IL10 (Interleukin 10)
    |
    Rituxan (rituximab) • lenalidomide • methotrexate • Inokai (orelabrutinib)