Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Last updated: March 31, 2025
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Lymphoma

Mantle Cell Lymphoma

Lymphoproliferative Disorders

Treatment

BGB-11417

Clinical Study ID

NCT05471843
BGB-11417-201
U1111-1279-0851
CTR20221815
2022-500687-35-00
  • Ages > 18
  • All Genders

Study Summary

The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Histologically confirmed diagnosis of MCL

  2. Prior systemic treatments for MCL (at least one line of anti-cluster ofdifferentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least onekind of covalent or non-covalent adequate Bruton Tyrosine Kinase (BTK) inhibitor).

  3. Relapsed/refractory disease

  4. Presence of measurable disease

  5. Availability of archival tissue confirming diagnosis of MCL, or willing to undergofresh tumor biopsy

  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.

  7. Adequate organ function

Exclusion

Key Exclusion Criteria:

  1. Known central nervous system involvement by lymphoma

  2. Prior malignancy other than MCL within the past 3 years, except for curativelytreated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma insitu of the cervix or breast, or localized Gleason score 6 prostate cancer.

  3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).

  4. Prior autologous stem cell transplant within the last 3 months; or prior autologouschimeric antigen receptor T-cell therapy within the last 3 months; or priorallogeneic stem cell transplant within the last 6 months or currently has an activegraft-vs-host disease requiring the use of immunosuppressants.

  5. Clinically significant cardiovascular disease.

  6. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.

  7. Active fungal, bacterial or viral infection requiring systemic treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 126
Treatment Group(s): 1
Primary Treatment: BGB-11417
Phase: 1/2
Study Start date:
September 05, 2022
Estimated Completion Date:
August 31, 2027

Connect with a study center

  • Hospital Aleman

    Ciudad Autonoma de Buenos Aires, C1118
    Argentina

    Site Not Available

  • Az Sint Jan Brugge

    Brugge, 8000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • University Hospitals Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • AZ DELTA

    Roeselare, 8800
    Belgium

    Site Not Available

  • Hospital Erasto Gaertner

    Curitiba, 81520-060
    Brazil

    Site Not Available

  • Hospital Mae de Deus

    Porto Alegre, 90110-270
    Brazil

    Site Not Available

  • Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp

    Ribeirao Preto, 14051-140
    Brazil

    Site Not Available

  • Instituto Americas Ensino, Pesquisa E Inovacao

    Rio de Janeiro, 22775-001
    Brazil

    Site Not Available

  • Oncoclinicas Rio de Janeiro Sa

    Rio de Janeiro, 22250-905
    Brazil

    Site Not Available

  • Hospital Sao Rafael (Rede Dor)

    Salvador, 41253-190
    Brazil

    Site Not Available

  • Accamargo Cancer Center

    Sao Paulo, 01508-010
    Brazil

    Site Not Available

  • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

    Sao Paulo, 05402-000
    Brazil

    Site Not Available

  • Hospital Beneficencia Portuguesa de Sao Paulo

    Sao Paulo, 01323-001
    Brazil

    Site Not Available

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    Sao Paulo, 01401-002
    Brazil

    Site Not Available

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    Sao Paulo, 05653-120
    Brazil

    Site Not Available

  • Qeii Health Science Center

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

    Hefei, Anhui 230088
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing
    China

    Active - Recruiting

  • Beijing Friendship Hospital, Capital Medical University(Tongzhou)

    Beijing, Beijing 101100
    China

    Site Not Available

  • China Japan Friendship Hospital

    Beijing, Beijing 100029
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Guangdong Provincial Peoples Hospital Huifu Branch

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Jiangmen Central Hospital

    Jiangmen, Guangdong 529030
    China

    Site Not Available

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangdong, Guangzhou
    China

    Site Not Available

  • Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou 550000
    China

    Site Not Available

  • Hainan General Hospital

    Haikou, Hainan 570206
    China

    Site Not Available

  • Hainan General Hospital

    Hainan, Hainan
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • The first affiliated hospital of Zhengzhou University - Oncology - Oncology

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu 201203
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • The affiliated Hospital of Xuzhou Medical university

    Xuzhou, Jiangsu 221006
    China

    Active - Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi 330029
    China

    Active - Recruiting

  • Jiangxi Province Cancer Hospital

    Nanchang, Jiangxi 330029
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning 110042
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750004
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University

    Huangdao, Qingdao 266500
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University Branch West Coast

    Qingdao, Shandong 266555
    China

    Site Not Available

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi 030013
    China

    Site Not Available

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi 140100
    China

    Site Not Available

  • West China Hospital ,Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin 300020
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • The First Peoples Hospital of Kashgar

    Kashgar, Xinjiang 844099
    China

    Site Not Available

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Urumqi, Xinjiang 830000
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • Centre Hospitalier Le Mans

    Le Mans, 72037
    France

    Site Not Available

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes Cedex, 44093
    France

    Site Not Available

  • Hopital Pitie Salpetriere Service Hematologie

    Paris, 75013
    France

    Site Not Available

  • Necker University Hospital

    Paris, 75015
    France

    Site Not Available

  • Chu Hopital Lyon Sud

    PierreBenite, 69495
    France

    Site Not Available

  • Chu Tours Hopital Bretonneau Service Pneumologie

    Tours, 37000
    France

    Site Not Available

  • Chu Tours Hopital Bretonneau Service Pneumologie

    Tours Cedex, 37000
    France

    Site Not Available

  • Universitatsklinikum Dusseldorf

    Dusseldorf, 40225
    Germany

    Site Not Available

  • Universitatsklinikum Essen (Aor)

    Essen, D-45147
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig Holstein, Campus Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Universitatsklinikum Koln, Innere Medizin I

    Koeln, 50937
    Germany

    Site Not Available

  • Assuta Ashdod Medical Center

    Ashdod, 7747629
    Israel

    Site Not Available

  • Hadassah En Karem Medical Center

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Rabin Medical Center

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Rabin Medical Centre

    Petach Tikva, 49100
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Tel Aviv, 5262100
    Israel

    Site Not Available

  • Sourasky Tel Aviv Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Tel Aviv Medical Center

    Tel Aviv, 64239
    Israel

    Active - Recruiting

  • Irccs Istituto Tumori Giovanni Paolo Ii

    Bari, 70124
    Italy

    Site Not Available

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    Meldola, 47014
    Italy

    Site Not Available

  • Aou Maggiore Della Carita

    Novara, 28100
    Italy

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952
    Poland

    Site Not Available

  • Pratia McM Krakow

    Krakow, 30-727
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr W Lublinie

    Lublin, 20-954
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Nr W Lublinie

    Lublin, 20-090
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy

    Warszawa, 02-034
    Poland

    Site Not Available

  • Auxilio Mutuo Cancer Center

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Institut Catala Dandoncologia

    Barcelona, 08908
    Spain

    Site Not Available

  • Institut Catala Doncologia

    Barcelona, 08908
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Ankara University Medical Faculty

    Ankara, 06620
    Turkey

    Site Not Available

  • Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

    Ankara, 06620
    Turkey

    Site Not Available

  • Gazi University

    Ankara, 6500
    Turkey

    Site Not Available

  • Ondokuz Mayis University Medicine Faculty Hospital

    Atakum Samsun, 55200
    Turkey

    Site Not Available

  • Bagcilar Medipol Mega Hospital

    Istanbul, 34214
    Turkey

    Site Not Available

  • Vkv American Hospital

    Istanbul, 34365
    Turkey

    Site Not Available

  • Ege University Medical Faculty

    Izmir, 35100
    Turkey

    Site Not Available

  • Erciyes University School of Medicine

    Kayseri, 38039
    Turkey

    Site Not Available

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380
    Turkey

    Site Not Available

  • The Christie Hospital

    Greater Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington, OX3 7LE
    United Kingdom

    Site Not Available

  • University College Hospital

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • Clatterbridge Cancer Centre

    Wirral, CH63 4JY
    United Kingdom

    Site Not Available

  • University of Alabama At Birmingham Hospital

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Banner MD Anderson Cancer Center

    Phoenix, Arizona 85234
    United States

    Site Not Available

  • Georgetown University Medical Center

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Medstar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Des Moines Oncology Research Association

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Iowa Oncology Research Association

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

  • Mission Cancer + Blood

    Newton, Iowa 50208
    United States

    Site Not Available

  • Tulane Cancer Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Maryland Oncology & Hematology

    Columbia, Maryland 21044
    United States

    Active - Recruiting

  • Maryland Oncology Hematology, Pa

    Columbia, Maryland 21044
    United States

    Site Not Available

  • University of Missouri Hospital, Ellis Fischel Cancer Center

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Nebraska Cancer Specialists

    Grand Island, Nebraska 68803
    United States

    Site Not Available

  • Dartmouth Cancer Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Novant Health Hematology Charlotte

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Northwest Medical Specialties

    Puyallup, Washington 98373
    United States

    Site Not Available

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