Drug or treatment

Orelabrutinib clinical trials

• 41Clinical trials
• 24Countries

Newest trials

All recruiting trials (41)

• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

  This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.

  Recruiting at 2 sites The First Affiliated Hospital of Xiamen University · Xiamen, Fujian and 1 other locations · NCT07778212

• Orelabrutinib with Obinutuzumab and Short-Course Venetoclax in Treatment-Naïve Mantle Cell Lymphoma

  This trial tests whether a combo of orelabrutinib, obinutuzumab, and a short course of venetoclax is safe and effective for adults with newly diagnosed mantle cell lymphoma.

  Recruiting at 2 sites Phase 2 The First Affiliated Hospital with Nanjing Medical University · Changzhou, Jiangsu and 1 other locations · NCT07719556

• Orelabrutinib plus standard immunochemotherapy with or without auto-HSCT for newly diagnosed DLBCL

  This study tests whether adding orelabrutinib to standard chemotherapy, with or without autologous stem cell transplantation, helps newly diagnosed DLBCL patients.

  Recruiting Phase 2 The Affiliated Hospital of Xuzhou Medical University · Xuzhou, Jiangsu · NCT07680933

• High-dose dexamethasone plus orelabrutinib versus placebo for newly diagnosed adult ITP

  This trial tests whether adding orelabrutinib to high-dose dexamethasone helps adults newly diagnosed with primary ITP raise and maintain their platelet counts compared with placebo.

  Recruiting Phase 3 Shandong University · Jinan, Shandong · NCT07559331

• Ultra-low-dose radiation followed by orelabrutinib for early-stage MALT lymphoma

  This study will test whether a short course of very low-dose radiation followed by daily orelabrutinib helps adults with stage I–II MALT lymphoma keep their disease controlled with acceptable side effects.

  Recruiting at 2 sites Phase 2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang and 1 other locations · NCT07554898

• Orelabrutinib for relapsed or refractory AIHA

  This study tests whether taking orelabrutinib by mouth can help adults with relapsed or refractory autoimmune hemolytic anemia (AIHA).

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07453368

• Orelabrutinib plus rituximab with optional lenalidomide for untreated marginal zone lymphoma using a response-adapted plan

  This will test whether giving orelabrutinib with rituximab, and adding lenalidomide for those who don't fully respond, helps people with newly diagnosed marginal zone lymphoma achieve complete remissions.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07448324

• Orelabrutinib for adults with early-stage untreated marginal zone lymphoma

  This trial will try orelabrutinib, a selective oral BTK inhibitor, as first-line treatment for adults with stage I–II marginal zone lymphoma to see if it works and is safe.

  Recruiting at 14 sites Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Guangzhou, Guangdong and 13 other locations · NCT07441993

• PD‑1 blocker with rituximab, high‑dose methotrexate, and orelabrutinib for newly diagnosed primary or secondary CNS lymphoma

  This trial will test whether combining a PD‑1 blocker with rituximab, high‑dose methotrexate, and orelabrutinib helps people with newly diagnosed primary or secondary central nervous system diffuse large B‑cell lymphoma.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07410520

• Orelabrutinib after short-course R-CHOP for people with newly diagnosed marginal zone lymphoma

  This treatment plan will try whether taking orelabrutinib after three cycles of R-CHOP helps people with newly diagnosed marginal zone lymphoma stay in remission.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07372365

• Orelabrutinib alone or with a CD20 antibody for people newly diagnosed with marginal zone lymphoma

  This trial tests if orelabrutinib by itself or together with a CD20 antibody can treat adults who have just been diagnosed with marginal zone lymphoma.

  Recruiting Phase 4 Beijing Tongren Hospital · Beijing and 2 other locations · NCT07355699

• Orelabrutinib for non-active secondary progressive multiple sclerosis

  This trial will try daily orelabrutinib versus placebo in adults with non-active secondary progressive multiple sclerosis to see if it slows disability progression.

  Recruiting at 89 sites Phase 3 Zenas BioPharma (USA), LLC · Phoenix, Arizona and 89 other locations · NCT07299019

• Orelabrutinib with lisaftoclax and rituximab for untreated high-risk mantle cell lymphoma

  This trial will try combining orelabrutinib, lisaftoclax, and rituximab in people with untreated, high-risk mantle cell lymphoma to see if it increases complete remissions and delays progression.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07272499

• Pomalidomide with orelabrutinib and zuberitamab for newly diagnosed mantle cell lymphoma

  This study tests whether adding pomalidomide to orelabrutinib and zuberitamab helps people with untreated mantle cell lymphoma become minimal residual disease (MRD) negative after six treatment cycles.

  Recruiting Peking University Third Hospital · Beijing, Beijing Municipality · NCT07257510

• Orelabrutinib plus zebetuzumab and lenalidomide vs bendamustine‑rituximab for newly diagnosed marginal zone lymphoma

  This study will test whether a combination of orelabrutinib, zebetuzumab, and lenalidomide helps people with newly diagnosed marginal zone lymphoma compared with a standard bendamustine plus rituximab regimen.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07208981

• Orelabrutinib with rituximab and optional autologous stem cell transplant for mantle cell lymphoma

  This phase 2 trial tests whether adding the oral BTK inhibitor orelabrutinib to rituximab, with optional autologous stem cell transplant and orelabrutinib maintenance, works and is safe for people with newly diagnosed non-high-risk mantle cell lymphoma.

  Recruiting Phase 2 Ruijin Hospital · Shanghai · NCT07199296

• Orelabrutinib and selinexor with methotrexate, thiotepa, or temozolomide for relapsed or refractory CNS lymphoma

  This trial will try adding oral orelabrutinib and selinexor to methotrexate (or thiotepa if MTX can't be used, or temozolomide) to see if it helps people with relapsed or refractory primary or secondary CNS lymphoma.

  Recruiting Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07191431

• Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL

  In this study, adults with newly diagnosed primary CNS lymphoma try different induction regimens to see which one works best before consolidation therapy.

  Recruiting at 9 sites Phase 2/3 Huashan Hospital · Beijing and 14 other locations · NCT07185373

• Orelabrutinib plus Pola‑R‑CHP for untreated non‑GCB diffuse large B‑cell lymphoma

  This trial tests whether adding orelabrutinib to the Pola‑R‑CHP chemotherapy improves responses in adults with newly diagnosed non‑GCB diffuse large B‑cell lymphoma.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07078500

• Combining pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin for elderly diffuse large B‑cell lymphoma

  This tests whether adding polatuzumab vedotin to a pomalidomide, rituximab and orelabrutinib regimen helps patients aged 70 and older with newly diagnosed diffuse large B‑cell lymphoma.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07072208

• Orelabrutinib treatment for primary progressive multiple sclerosis

  This trial tests whether orelabrutinib, a brain-penetrant BTK inhibitor, can slow disability progression in adults with primary progressive MS.

  Recruiting at 86 sites Phase 3 Zenas BioPharma (USA), LLC · Pheonix, Arizona and 85 other locations · NCT07067463

• First-line treatment with orelabrutinib plus rituximab for marginal zone lymphoma

  This will test whether taking orelabrutinib together with rituximab works and is safe as a first systemic treatment for adults with marginal zone lymphoma.

  Recruiting at 18 sites Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang and 17 other locations · NCT07022223

• Combining Orelabrutinib and Zuberitamab for treating Marginal Zone Lymphoma

  This study is testing if combining two medications, Orelabrutinib and Zuberitamab, can help people with untreated Marginal Zone Lymphoma feel better and have fewer side effects.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong and 1 other locations · NCT06985472

• Orelabrutinib plus rituximab versus R‑CVP as first-line treatment for marginal zone lymphoma

  This test will see if orelabrutinib plus rituximab, followed by orelabrutinib maintenance, works as well or better than standard R‑CVP chemotherapy for adults with untreated marginal zone lymphoma.

  Recruiting Phase 2 The First Affiliated Hospital of Nanchang University · Nanchang, Jiangxi · NCT06700798

• Combining orelabrutinib with R-CHOP for treating CD5-positive DLBCL

  This study is testing if adding a new drug called orelabrutinib to the standard R-CHOP treatment can help people with untreated CD5-positive diffuse large B-cell lymphoma live longer without their cancer coming back.

  Recruiting at 11 sites Phase 2 Sun Yat-sen University · Guangzhou, China and 10 other locations · NCT06647940

• Orelabrutinib and Obinutuzumab for Treating Marginal Zone Lymphoma

  This study is testing a new treatment combining Orelabrutinib and Obinutuzumab for people with previously untreated Marginal Zone Lymphoma to see if it works better and is safer than traditional chemotherapy.

  Recruiting Phase 2 Huai'an First People's Hospital · Huai'an, Jiangsu · NCT06566807

• Orelabrutinib combined with BR/G for untreated Marginal Zone Lymphoma

  This study is testing if a new drug called Orelabrutinib, combined with other treatments, can help younger and older patients with untreated Marginal Zone Lymphoma feel better and have fewer side effects.

  Recruiting Phase 2 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT06504940

• Treatment for ocular adnexal lymphoma using Orelabrutinib and radiotherapy

  This study is testing if a new drug called Orelabrutinib combined with low-dose radiation can help newly diagnosed patients with early-stage ocular adnexal lymphoma feel better and live longer.

  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT06503276

• Combining Orelabrutinib with Bendamustine and Rituximab for treating Mantle Cell Lymphoma

  This study is testing if adding Orelabrutinib to the standard treatment of Bendamustine and Rituximab can help people with intermediate- to high-risk mantle cell lymphoma who can't have a transplant feel better and live longer.

  Recruiting Phase 3 Ruijin Hospital · Shanghai · NCT06496308

• Combining Orelabrutinib and Rituximab for Treating Marginal Zone Lymphoma

  This study is testing if combining two medications, Orelabrutinib and Rituximab, can help adults with Marginal Zone Lymphoma who haven't responded to other treatments or can't have local therapy.

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT06478472

• Combination treatment for marginal zone lymphoma

  This study is testing a new combination of three medications to see if it can help people with untreated marginal zone lymphoma get better.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT06454968

• Combining ICP-248 and Orelabrutinib for treating chronic lymphocytic leukemia

  This study is testing if combining two medications, ICP-248 and Orelabrutinib, can help people with newly diagnosed chronic lymphocytic leukemia or small lymphocytic lymphoma feel better and improve their treatment results.

  Recruiting at 44 sites Phase 2/3 Beijing InnoCare Pharma Tech Co., Ltd. · Bengbu, Anhui and 52 other locations · NCT06378138

• Comparing Orelabrutinib with standard treatment for mantle cell lymphoma

  This study is testing if adding a new drug called Orelabrutinib to the standard treatment can help older patients with untreated mantle cell lymphoma feel better and improve their outcomes.

  Recruiting at 19 sites Phase 3 InnoCare Pharma Inc. · Beijing and 38 other locations · NCT06363994

• Treatment of HP-positive gastric MALT lymphoma with Orelabrutinib

  This study is testing if a new treatment called Orelabrutinib, combined with standard therapy for Helicobacter pylori, can help people with HP-positive gastric MALT lymphoma feel better compared to usual treatments.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT06228963

• Testing a new treatment for relapsed marginal zone lymphoma

  This study is testing a new combination of Orelabrutinib and rituximab to see if it helps people with relapsed marginal zone lymphoma who haven't had success with other treatments.

  Recruiting at 3 sites Phase 4 Ningbo No. 1 Hospital · Hangzhou, Zhejiang and 2 other locations · NCT06134284

• Combining Orelabrutinib with Lenalidomide and Rituximab for treating relapsed Marginal Zone Lymphoma

  This study is testing if adding a new drug called Orelabrutinib to the standard treatment of Lenalidomide and Rituximab can help people with relapsed Marginal Zone Lymphoma feel better and improve their outcomes.

  Recruiting at 16 sites Phase 3 Beijing InnoCare Pharma Tech Co., Ltd. · Bengbu, Auhui and 18 other locations · NCT06082102

• Combining orelabrutinib with R-CHOP for treating newly diagnosed double expression DLBCL

  This study is testing if adding orelabrutinib to the standard R-CHOP treatment can help people newly diagnosed with a specific aggressive type of lymphoma feel better.

  Recruiting at 2 sites Phase 2 Shandong Cancer Hospital and Institute · Nanchang, Jiangxi and 1 other locations · NCT05933967

• Combination treatment for newly diagnosed primary central nervous system lymphoma

  This study is testing a new combination of treatments for people with newly diagnosed primary central nervous system lymphoma to see if it helps them respond better and live longer.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hanzhou, Zhejiang · NCT05600660

• Combining orelabrutinib and pemetrexed for treating relapsed central nervous system lymphoma

  This study is testing if combining orelabrutinib with pemetrexed can help people with relapsed central nervous system lymphoma feel better and improve their treatment outcomes.

  Recruiting Phase 2 Henan Cancer Hospital · Zhengzhou, Henan · NCT05209620

• Orelabrutinib plus rituximab followed by orelabrutinib maintenance for relapsed or refractory follicular lymphoma

  This trial tests whether combining orelabrutinib with rituximab, followed by orelabrutinib alone, helps people whose follicular lymphoma has come back or stopped responding.

  Recruiting at 2 sites Phase 2 Sun Yat-sen University · Guangzhou, Guangdong and 2 other locations · NCT04989621

• Combining orelabrutinib and sintilimab for treating relapsed central nervous system lymphoma

  This study is testing a combination of two drugs, orelabrutinib and sintilimab, to see if they can help people with relapsed central nervous system lymphoma feel better.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT04961515

Quick answers

How many clinical trials of Orelabrutinib are recruiting right now?

41, as of November 12, 2026. We update this list each time we refresh our data from ClinicalTrials.gov.

Where are these trials running?

In 24 countries. The most sites are in China (39 trials), Australia (2 trials), Bulgaria (2 trials), Croatia (2 trials), Czechia (2 trials). Each study page lists its sites and which ones are recruiting.

What phases are they in?

Phase 2: 26, Phase 3: 6, Phase 2/3: 2, Phase 4: 2. Trials with no phase listed are usually device, behavioural or observational studies.

How do I join one?

Open a study, check the "Is this trial a fit for you?" section, then contact the study team listed on the page. They will ask a few screening questions. Asking is free and does not commit you to anything. Talk it over with your doctor first.

Find the studies that fit you

A list is a starting point. Tell us your situation in your own words and we'll rank the studies that match and explain why. It's free and needs no account.

Describe your situation →