36 recruiting, 29 unknown, 13 not yet recruiting, 7 completed. 59 Phase 2, 17 Phase 3, 10 Phase 1, 5 Not applicable, 1 Phase 4.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL). ICP-248, Pirtobrutinib, Orelabrutinib - Relapsed or Refractory Mantle Cell Lymphoma (MCL) | Phase 3 | Not yet recruiting | Beijing InnoCare Pharma Tech Co., Ltd. | 280 | 2026-10-01 | 2026-08-25 |
| Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS) Orelabrutinib - Amyotrophic Lateral Sclerosis (ALS) | Phase 1 | Not yet recruiting | Liu Qing | 12 | 2026-10-01 | 2026-10-15 |
| Orelabrutinib Plus ICP 248 vs Orelabrutinib for Relapsed/Refractory Marginal Zone Lymphoma Orelabrutinib, ICP-248 - Relapsed/Refractory Marginal Zone Lymphoma (MZL) | Phase 3 | Not yet recruiting | Beijing InnoCare Pharma Tech Co., Ltd. | 292 | 2026-10-01 | 2026-10-27 |
| Orelabrutinib Combined With Pola-R-CHP as First-Line Treatment for Patients With Intermediate- to High-Risk DLBCL Orelabrutinib Combined with Pola-R-CHP Regimen - DLBCL - Diffuse Large B Cell Lymphoma, Intermediate-High Risk | Not applicable | Recruiting | The First Affiliated Hospital of Xiamen University | 30 | 2026-08-30 | 2026-08-21 |
| Orelabrutinib Combined With Obinutuzumab and Short-Course Venetoclax in Patients With Treatment-Naïve Mantle Cell Lymphoma (MCL) Orelabrutinib, Obinutuzumab, Venetoclax - Mantle Cell Lymphoma (MCL) | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 39 | 2026-07-15 | 2026-07-22 |
| A Multicenter, Prospective, Open-Label, Randomized Controlled Clinical Study of Orelabrutinib Combined With Obinutuzumab and Lenalidomide Versus Obinutuzumab Plus Chemotherapy for Treatment-Naive Follicular Lymphoma Orelabrutinib, obinutuzumab, Lenalidomide - Follicular Lymphoma ( FL) | Phase 3 | Not yet recruiting | Ruijin Hospital | 652 | 2026-07-01 | 2026-07-22 |
| Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma R-CHOP+Orelabrutinib, POLA-R-CHP+orelabrutinib, R-miniCHOP +orelabrutinib - DLBCL - Diffuse Large B Cell Lymphoma | Phase 2 | Not yet recruiting | Ou Bai, MD/PHD | 66 | 2026-06-16 | 2026-07-01 |
| Ultra-low-dose Radiation Therapy Followed by Orelabrutinib as First-line Treatment for Stage Ⅰ-Ⅱ MALT Lymphoma Orelabrutinib, Ultra-low-dose Radiation Therapy - MALT Lymphoma | Phase 2 | Recruiting | Zhejiang Cancer Hospital | 60 | 2026-04-16 | 2026-05-11 |
| A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide Orelabrutinib, Tafasitamab, Lenalidomide - Follicular Lymphoma | Phase 2 | Not yet recruiting | Institute of Hematology & Blood Diseases Hospital, China | 27 | 2026-04-15 | 2026-05-14 |
| High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia High-Dose Dexamethasone Combined with Orelabrutinib, High-Dose Dexamethasone Combined with Placebo - Primary Immune Thrombocytopenia (ITP) | Phase 3 | Recruiting | Shandong University | 86 | 2026-04-08 | 2026-04-30 |
| Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy Orelabrutinib, Romiplostim N01 - Primary Immune Thrombocytopenia (ITP) | Phase 2 | Not yet recruiting | Peking Union Medical College Hospital | 28 | 2026-04-01 | 2026-02-10 |
| A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis Orelabrutinib, Placebo - Multiple Sclerosis (MS) Primary Progressive | Phase 3 | Recruiting | Zenas BioPharma (USA), LLC | 705 | 2026-03-23 | 2026-10-27 |
| A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis Orelabrutinib, Placebo - Secondary Progressive Multiple Sclerosis | Phase 3 | Recruiting | Zenas BioPharma (USA), LLC | 990 | 2026-03-23 | 2026-10-27 |
| PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL. PD -1/PD-L1 monoclonal antibody, Rituximab (R), Methotrexate - Primary Central Nervous System Lymphoma (PCNSL), Secondary Central Nervous System Lymphoma (SCNSL) | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 50 | 2026-02-07 | 2026-02-13 |
| A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma Rocbrutinib, Ibrutinib, Acalabrutinib - Mantle Cell Lymphoma | Phase 3 | Recruiting | Guangzhou Lupeng Pharmaceutical Company LTD. | 394 | 2026-02-05 | 2026-02-06 |
| Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL Orelabrutinib - Marginal Zone Lymphoma | Phase 2 | Recruiting | Institute of Hematology & Blood Diseases Hospital, China | 30 | 2026-01-05 | 2026-03-02 |
| Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation POLA-R-CHP, Orelabrutinib - Diffuse Large B-Cell Lymphoma (DLBCL) | Phase 2 | Recruiting | The First Affiliated Hospital of Soochow University | 35 | 2026-01-01 | 2026-03-30 |
| Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy Venetoclax combined with Ibrutinib, Venetoclax combined with Zanubrutinib, Venetoclax combined with Acalabrutinib - Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) | Phase 2 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 79 | 2025-12-01 | 2025-11-25 |
| Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma Orelabrutinib - Marginal Zone Lymphoma(MZL) | Phase 4 | Recruiting | Beijing Tongren Hospital | 88 | 2025-11-25 | 2026-01-21 |
| Treatment of Orelabrutinib+Hi-CVP Regimen for Previously Untreated MZL Orelabrutinib, Zuberitamab, Cyclophosphamide - Marginal Zone Lymphoma(MZL) | Phase 2 | Active not recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 65 | 2025-10-01 | 2026-04-02 |
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Lymphoma, B-Cell, Marginal Zone (16) · Lymphoma, Mantle-Cell (12) · Lymphoma, Large B-Cell, Diffuse (8) · Purpura, Thrombocytopenic, Idiopathic (5) · Recurrence (4) · Lymphoma (3) · Lymphoma, Follicular (3) · Dendritic Cell Sarcoma, Interdigitating (2) · Leukemia, Lymphocytic, Chronic, B-Cell (2) · Lupus Erythematosus, Systemic (2) · Lymphoma, B-Cell (2) · Multiple Sclerosis, Chronic Progressive (2) · Amyotrophic Lateral Sclerosis (1) · Bronchiolitis Obliterans Syndrome (1) · Hematologic Neoplasms (1)
Beijing InnoCare Pharma Tech Co., Ltd. (16) · Ruijin Hospital (11) · The First Affiliated Hospital with Nanjing Medical University (8) · Peking Union Medical College Hospital (5) · Huashan Hospital (3) · Institute of Hematology & Blood Diseases Hospital, China (3) · Peking University People's Hospital (3) · Second Affiliated Hospital, Zhejiang University, School of Medicine (3) · Sun Yat-sen University (3) · The First Affiliated Hospital of Soochow University (3) · Fei Li (2) · Fudan University (2) · InnoCare Pharma Inc. (2) · Shandong University (2) · The First Affiliated Hospital of Xiamen University (2)
China (79) · Poland (4) · Ukraine (4) · United States (4) · Bulgaria (2) · Croatia (2) · Czechia (2) · Estonia (2) · Georgia (2) · Italy (2) · Puerto Rico (2) · Serbia (2) · Spain (2) · Australia (1) · Germany (1)
Tong Chen (3) · Shenmiao Yang (2) · Bing Xu (1) · Bing Xu, PhD，MD (1) · Fei Li, professor (1) · Huilai Zhang, PHD (1) · Jianyong Li, Phd, MD (1) · Jun Shi (1) · Liang Wang (1) · Liang Wang, MD (1) · Ming Hou, MD,PhD (1) · Qingqing Cai (1) · Rong Tao (1) · Ru Feng, Master (1) · Shaoying Chen (1)
PMID 40550489, PMID 26096944, PMID 38546375, PMID 40425940, PMID 42214214, PMID 42630801