Clinical Trials
Orelabrutinib is under evaluation in numerous clinical trials ranging from Phase I to Phase IV, investigating various B-cell malignancies—including chronic lymphocytic leukemia, mantle cell, marginal zone, and diffuse large B-cell lymphomas—as well as immune thrombocytopenia and pharmacokinetic profiles in healthy volunteers. Sponsored by academic centers and pharmaceutical companies like Peking University People's Hospital and Beijing InnoCare Pharma Tech Co. Ltd., study statuses range from active recruiting to completed. Investigations include orelabrutinib for patients with suboptimal responses to prior ibrutinib therapy and in combination chemoimmunotherapy regimens for central nervous system lymphoma.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07784101 | NOT_YET_RECRUITING | Relapsed or Refractory Mantle Cell Lymphoma (MCL) |
Beijing InnoCare Pharma Tech Co., Ltd. |
2026-10 | PHASE3 |
| NCT06363994 | RECRUITING | Mantle Cell Lymphoma |
InnoCare Pharma Inc. |
2024-05-29 | PHASE3 |
| NCT07377578 | RECRUITING | Mantle Cell Lymphoma |
Guangzhou Lupeng Pharmaceutical Company LTD. |
2026-02-05 | PHASE3 |
| NCT06378138 | RECRUITING | Hematologic Malignancies |
Beijing InnoCare Pharma Tech Co., Ltd. |
2024-05-15 | PHASE2; PHASE3 |
| NCT07719855 | NOT_YET_RECRUITING | Follicular Lymphoma ( FL) |
Ruijin Hospital |
2026-07 | PHASE3 |
| NCT07299019 | RECRUITING | Secondary Progressive Multiple Sclerosis |
Zenas BioPharma (USA), LLC |
2026-03-23 | PHASE3 |
| NCT07067463 | RECRUITING | Multiple Sclerosis (MS) Primary Progressive |
Zenas BioPharma (USA), LLC |
2026-03-23 | PHASE3 |
| NCT07677813 | NOT_YET_RECRUITING | DLBCL - Diffuse Large B Cell Lymphoma |
Ou Bai, MD/PHD |
2026-06-16 | PHASE2 |
| NCT07585747 | NOT_YET_RECRUITING | Follicular Lymphoma |
Institute of Hematology & Blood Diseases Hospital, China |
2026-04-15 | PHASE2 |
| NCT07198464 | NOT_YET_RECRUITING | Primary Central Nervous System Lymphoma (PCNSL) |
Zhengzhou University |
2025-10-07 | |
| NCT07480863 | ACTIVE_NOT_RECRUITING | Marginal Zone Lymphoma(MZL) |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2025-10-01 | PHASE2 |
| NCT07719556 | RECRUITING | Mantle Cell Lymphoma (MCL) |
The First Affiliated Hospital with Nanjing Medical University |
2026-07-15 | PHASE2 |
| NCT07410520 | RECRUITING | Primary Central Nervous System Lymphoma (PCNSL); Secondary Central Nervous System Lymphoma (SCNSL) |
The First Affiliated Hospital with Nanjing Medical University |
2026-02-07 | PHASE2 |
| NCT06793189 | RECRUITING | Marginal Zone Lymphoma(MZL) |
Ruijin Hospital |
2025-01-23 | PHASE2 |
| NCT06516978 | NOT_YET_RECRUITING | Diffuse Large B Cell Lymphoma |
The First Affiliated Hospital with Nanjing Medical University |
2024-10-01 | PHASE2 |
| NCT07185373 | RECRUITING | Primary Central Nervous System Lymphoma |
Huashan Hospital |
2025-10-01 | PHASE2; PHASE3 |
| NCT07272499 | RECRUITING | Mantle Cell Lymphoma (MCL) |
Ruijin Hospital |
2025-09-10 | PHASE2 |
| NCT06082102 | RECRUITING | Relapsed/Refractory Marginal Zone Lymphoma |
Beijing InnoCare Pharma Tech Co., Ltd. |
2023-12-19 | PHASE3 |
| NCT07257510 | RECRUITING | Mantle Cell Lymphoma (MCL); POZ |
Peking University Third Hospital |
2025-08-01 | |
| NCT07705308 | NOT_YET_RECRUITING | Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) |
Ruijin Hospital |
2026-08-01 | PHASE2 |
| NCT07199296 | RECRUITING | Mantle Cell Lymphoma (MCL) |
Ruijin Hospital |
2025-07-01 | PHASE2 |
| NCT07208981 | RECRUITING | Marginal Zone Lymphoma(MZL) |
The First Affiliated Hospital with Nanjing Medical University |
2025-08-14 | PHASE2 |
| NCT07372365 | RECRUITING | Marginal Zone Lymphoma (MZL) |
The First Affiliated Hospital of Soochow University |
2025-10-24 | PHASE2 |
| NCT07554898 | RECRUITING | MALT Lymphoma |
Zhejiang Cancer Hospital |
2026-04-16 | PHASE2 |
| NCT07448324 | RECRUITING | Marginal Zone Lymphoma(MZL) |
The First Affiliated Hospital with Nanjing Medical University |
2025-04-01 | PHASE2 |
| NCT07247383 | ACTIVE_NOT_RECRUITING | Marginal Zone Lymphoma of Ocular Adnexal; Marginal Zone Lymphoma(MZL) |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2025-09-19 | PHASE2 |
| NCT07499271 | RECRUITING | Diffuse Large B-Cell Lymphoma (DLBCL) |
The First Affiliated Hospital of Soochow University |
2026-01-01 | PHASE2 |
| NCT06958705 | RECRUITING | Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) |
The First Affiliated Hospital with Nanjing Medical University |
2025-12-01 | PHASE2 |
| NCT07441993 | RECRUITING | Marginal Zone Lymphoma |
Institute of Hematology & Blood Diseases Hospital, China |
2026-01-05 | PHASE2 |
| NCT07206264 | NOT_YET_RECRUITING | Mantle Cell Lymphoma |
Tianjin Medical University Cancer Institute and Hospital |
2025-10 | PHASE2 |
| NCT07355699 | RECRUITING | Marginal Zone Lymphoma(MZL) |
Beijing Tongren Hospital |
2025-11-25 | PHASE4 |
| NCT07778212 | RECRUITING | DLBCL - Diffuse Large B Cell Lymphoma; Intermediate-High Risk; First-Line |
The First Affiliated Hospital of Xiamen University |
2026-08-30 | |
| NCT07022223 | RECRUITING | Marginal Zone Lymphoma(MZL) |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2025-03-11 | PHASE2 |
| NCT07191431 | RECRUITING | Lymphoma Cns |
Ruijin Hospital |
2025-09-22 | |
| NCT06496308 | RECRUITING | Mantle Cell Lymphoma (MCL) |
Ruijin Hospital |
2024-07-10 | PHASE3 |
| NCT06504940 | RECRUITING | Marginal Zone Lymphoma |
First Affiliated Hospital of Zhejiang University |
2024-06-28 | PHASE2 |
| NCT07008053 | NOT_YET_RECRUITING | Marginal Zone Lymphomas |
Tianjin Medical University Cancer Institute and Hospital |
2025-07 | PHASE2 |
| NCT07680933 | RECRUITING | DLBCL - Diffuse Large B Cell Lymphoma |
The Affiliated Hospital of Xuzhou Medical University |
2026-03-01 | PHASE2 |
| NCT06478472 | RECRUITING | Marginal Zone Lymphoma |
The First Affiliated Hospital of Xiamen University |
2024-06-23 | |
| NCT07072208 | RECRUITING | Diffuse Large B-Cell Lymphoma |
The First Affiliated Hospital of Soochow University |
2024-11-01 | |
| NCT07559331 | RECRUITING | Primary Immune Thrombocytopenia (ITP) |
Shandong University |
2026-04-08 | PHASE3 |
| NCT07453368 | RECRUITING | Autoimmune Hemolytic Anemia (AIHA) |
Peking Union Medical College Hospital |
2026-03-01 | PHASE2 |
| NCT06134284 | RECRUITING | OR Regimen for Relapsed/Refractory Marginal Zone Lymphoma |
Lixia Sheng |
2023-01-02 | PHASE4 |
| NCT06701357 | RECRUITING | DLBCL |
Ruijin Hospital |
2024-12-10 | PHASE2 |
| NCT06656221 | NOT_YET_RECRUITING | Mantle Cell Lymphoma |
Ruijin Hospital |
2024-12-01 | PHASE2 |
| NCT06647940 | RECRUITING | Diffuse Large B Cell Lymphoma (DLBCL) |
Sun Yat-sen University |
2024-11-01 | PHASE2 |
| NCT06901999 | NOT_YET_RECRUITING | CNS Lymphoma |
Ruijin Hospital |
2025-04 | PHASE2 |
| NCT07078500 | RECRUITING | Diffuse Large B-Cell Lymphoma (DLBCL) |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2025-05-05 | PHASE2 |
| NCT07400250 | NOT_YET_RECRUITING | Primary Immune Thrombocytopenia (ITP) |
Peking Union Medical College Hospital |
2026-04-01 | PHASE2 |
| NCT06566807 | RECRUITING | Marginal Zone Lymphoma |
Huai'an First People's Hospital |
2024-08-25 | PHASE2 |
| NCT04989621 | RECRUITING | Follicular Lymphoma; Relapsed and Refractory Follicular Lymphoma |
Sun Yat-sen University |
2021-08-01 | PHASE2 |
| NCT04014205 | ACTIVE_NOT_RECRUITING | Part 1：r/r B-cell Malignancies; Part 2：B-cell Malignancies |
Beijing InnoCare Pharma Tech Co., Ltd. |
2019-11-18 | PHASE1; PHASE2 |
| NCT06513234 | RECRUITING | Marginal Zone Lymphoma |
Institute of Hematology & Blood Diseases Hospital, China |
2024-07-11 | PHASE2 |
| NCT06454968 | RECRUITING | Marginal Zone Lymphoma |
Peking Union Medical College Hospital |
2024-06-20 | PHASE2 |
| NCT05351346 | UNKNOWN | Diffuse Large B Cell Lymphoma |
Ruijin Hospital |
2022-06-01 | PHASE3 |
| NCT06700798 | RECRUITING | Marginal Zone Lymphoma(MZL) |
Fei Li |
2024-12-01 | PHASE2 |
| NCT05926427 | UNKNOWN | CNS Lymphoma |
Ruijin Hospital |
2023-08-10 | PHASE2 |
| NCT06476899 | NOT_YET_RECRUITING | CLL/SLL |
Fei Li |
2024-07-24 | PHASE2 |
| NCT04711148 | UNKNOWN | Relapsing Remitting Multiple Sclerosis |
Beijing InnoCare Pharma Tech Co., Ltd. |
2021-03-01 | PHASE2 |
| NCT06530511 | UNKNOWN | Diffuse Large B Cell Lymphoma |
Affiliated Hospital of Nantong University |
2024-08-01 | PHASE2 |
| NCT06228963 | RECRUITING | MALT Lymphoma of Stomach; Helicobacter Pylori Infection |
Fudan University |
2024-03 | PHASE2 |
| NCT06004856 | UNKNOWN | Chronic Primary Immune Thrombocytopenia (ITP) |
Beijing InnoCare Pharma Tech Co., Ltd. |
2023-10-26 | PHASE3 |
| NCT05600660 | RECRUITING | Primary Central Nervous System Lymphoma |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2022-08-01 | PHASE2 |
| NCT04961515 | RECRUITING | Primary Central Nervous System Hodgkin Lymphoma |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2021-07-01 | PHASE2 |
| NCT04304040 | UNKNOWN | B-cell Lymphoma Recurrent; B-cell Lymphoma Refractory |
Beijing InnoCare Pharma Tech Co., Ltd. |
2020-07-28 | PHASE1; PHASE2 |
| NCT06985472 | RECRUITING | Initial MZL; Untreated MZL; BTKi; CD20 |
Li Zhiming |
2024-11-13 | PHASE2 |
| NCT06503276 | RECRUITING | Extranodal Marginal Zone B-cell Lymphoma |
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
2023-11-01 | PHASE2 |
| NCT05728658 | RECRUITING | Hematological Malignancies |
Beijing InnoCare Pharma Tech Co., Ltd. |
2023-03-09 | PHASE1 |
| NCT05688696 | UNKNOWN | Systemic Lupus Erythematosus, SLE |
Beijing InnoCare Pharma Tech Co., Ltd. |
2023-04-29 | PHASE2 |
| NCT06583837 | ACTIVE_NOT_RECRUITING | Lymphoma, B-Cell, Marginal Zone |
Fudan University |
2024-09-10 | PHASE2 |
| NCT05809180 | UNKNOWN | Diffuse Large B Cell Lymphoma |
The First Affiliated Hospital of Soochow University |
2023-01-04 | |
| NCT05051891 | COMPLETED | Treatment-naїve Mantle Cell Lymphoma |
Beijing InnoCare Pharma Tech Co., Ltd. |
2021-12-22 | PHASE3 |
| NCT05209620 | RECRUITING | Central Nervous System Lymphoma |
Henan Cancer Hospital |
2021-12-21 | PHASE2 |
| NCT06290817 | UNKNOWN | Diffuse Large B-cell Lymphoma |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2023-03-30 | PHASE2 |
| NCT05322733 | UNKNOWN | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
The First Affiliated Hospital with Nanjing Medical University |
2022-04-15 | PHASE2 |
| NCT05918276 | NOT_YET_RECRUITING | CLL/SLL |
Nanfang Hospital, Southern Medical University |
2023-07-15 | PHASE2 |
| NCT05933967 | RECRUITING | The First Affiliated Hospital of Nanchang University |
Shandong Cancer Hospital and Institute |
2023-06-01 | PHASE2 |
| NCT05978739 | COMPLETED | Mantle Cell Lymphoma |
InnoCare Pharma Inc. |
2023-08-18 | PHASE2 |
| NCT05491044 | UNKNOWN | CLL/SLL |
Peking University People's Hospital |
2022-01-01 | PHASE2 |
| NCT05234684 | UNKNOWN | Diffuse Large B Cell Lymphoma (DLBCL) |
Beijing InnoCare Pharma Tech Co., Ltd. |
2022-11-02 | PHASE3 |
| NCT06454266 | COMPLETED | Primary Central Nervous System Lymphoma |
Ningbo No. 1 Hospital |
2021-12-28 | PHASE2 |
| NCT05334238 | UNKNOWN | Primary Central Nervous System Lymphoma |
Ruijin Hospital |
2021-12-01 | PHASE3 |
| NCT05390749 | UNKNOWN | Primary Central Nervous System Lymphoma |
Peking Union Medical College Hospital |
2022-04-11 | PHASE2 |
| NCT05784987 | UNKNOWN | Diffuse Large B-cell Lymphoma |
The First Affiliated Hospital with Nanjing Medical University |
2023-04-15 | |
| NCT05498259 | UNKNOWN | Diffuse Large B-Cell Lymphoma |
The First Affiliated Hospital of Soochow University |
2022-07-27 | PHASE2 |
| NCT05097443 | UNKNOWN | High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements; High Grade B-Cell Lymphoma, Not Otherwise Specified; Diffuse Large B-cell Lymphoma; Mantle Cell Lymphoma; B-cell NonHodgkin Lymphoma |
Shandong Provincial Hospital |
2021-04-15 | PHASE3 |
| NCT05020288 | UNKNOWN | Immune Thrombocytopenia; Bruton's Tyrosine Kinase |
Shandong University |
2021-09-01 | PHASE2 |
| NCT05036577 | COMPLETED | Primary Central Nervous System Lymphoma |
Huashan Hospital |
2021-10-10 | PHASE1 |
| NCT05684653 | UNKNOWN | Hepatic Impairment |
Beijing InnoCare Pharma Tech Co., Ltd. |
2023-03-17 | PHASE1 |
| NCT05232149 | UNKNOWN | Primary Immune Thrombocytopenia |
Beijing InnoCare Pharma Tech Co., Ltd. |
2022-02-21 | PHASE2 |
| NCT05381506 | UNKNOWN | DLBCL |
Sun Yat-sen University |
2022-07 | PHASE2 |
| NCT05284175 | UNKNOWN | Neuromyelitis Optica Spectrum Disorder |
Peking Union Medical College Hospital |
2022-04 | |
| NCT05660720 | UNKNOWN | Healthy Subject |
Beijing InnoCare Pharma Tech Co., Ltd. |
2022-11-19 | PHASE1 |
| NCT05549284 | UNKNOWN | Primary Central Nervous System Lymphoma |
Affiliated Hospital to Academy of Military Medical Sciences |
2022-06-01 | PHASE2 |
| NCT04899427 | UNKNOWN | Primary Central Nervous System Lymphoma |
Peking Union Medical College Hospital |
2021-03-24 | PHASE2 |
| NCT05021770 | UNKNOWN | Refractory and Relapsed Primary CNS Lymphoma; PCNSL; Non Hodgkin Lymphoma |
Huiqiang Huang |
2021-12 | PHASE1; PHASE2 |
| NCT05076097 | UNKNOWN | Mantle Cell Lymphoma |
Tianjin Medical University Cancer Institute and Hospital |
2021-09-30 | PHASE2 |
| NCT05014100 | UNKNOWN | B-cell Lymphoma |
Puyang Oilfield General Hospital |
2021-09-01 | PHASE2 |
| NCT05124028 | UNKNOWN | Immune Thrombocytopenia |
Peking University People's Hospital |
2021-12-01 | PHASE1; PHASE2 |
| NCT05316857 | COMPLETED | Healthy Person |
Beijing InnoCare Pharma Tech Co., Ltd. |
2021-12-16 | PHASE1 |
| NCT05491044 | Recruiting | CLL/SLL |
Peking University People''s Hospital |
2022-01-01 | Phase 2 |
| NCT05021770 | Not yet recruiting | Refractory and Relapsed Primary CNS Lymphoma|PCNSL|Non Hodgkin Lymphoma |
Huiqiang Huang|Guangdong 999 Brain Hospital|Sun Yat-sen University |
2021-12 | Phase 1|Phase 2 |
| NCT05020288 | Not yet recruiting | Immune Thrombocytopenia|Bruton''s Tyrosine Kinase |
Shandong University |
2021-09-01 | Phase 2 |
| NCT04441450 | Completed | Healthy Volunteers |
Beijing InnoCare Pharma Tech Co. Ltd. |
2019-07-01 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2026-08-25)
Check the
Orelabrutinib
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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Note: Technical data last updated: Sep 1, 2026.