^
    6d
    BTKi orelabrutinib improved the outcome of newly-diagnosed PCNS-LBCL by alleviating MyD88L265P-induced PIM1 stability. (PubMed, J Hematol Oncol)
    To evaluate the intracranial delivery of BTK inhibitor(BTKi), patient-derived PCNS-LBCL xenografted mice models were treated with highly-selective BTKi orelabrutinib, either monotherapeutically or in combining with methotrexate...The mutations in CSF circulating tumor DNA (ctDNA) rather than plasma-ctDNA were more consistent to those in tumor tissue, indicating that CSF-ctDNA is a useful tool for monitoring PCNS-LBCL. In summary, our data provided the molecular rationale as well as clinical evidences that incorporation of BTKi into frontline induction therapy is a promising strategy for ND PCNS-LBCL.
    Journal
    |
    CD79B (CD79b Molecule) • PIM1 (Pim-1 Proto-Oncogene)
    |
    methotrexate • Inokai (orelabrutinib) • methotrexate IV
    12d
    Evaluating Different Doses of Orelabrutinib in MCL (clinicaltrials.gov)
    P2, N=40, Completed, InnoCare Pharma Inc. | Recruiting --> Completed
    Trial completion
    |
    Inokai (orelabrutinib)
    15d
    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)
    16d
    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)
    21d
    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)
    1m
    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)
    1m
    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)
    2ms
    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
    2ms
    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)