Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies

Last updated: April 17, 2026
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

BGB-11417

Clinical Study ID

NCT04883957
BGB-11417-102
CTR20211017
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and tolerability of BGB-11417 monotherapy, define the maximum tolerated dose (MTD) or maximum administered dose and the recommended Phase 2 dose (RP2D) of BGB-11417 monotherapy for the selected B-cell malignancy dose finding cohorts, and evaluate the safety and tolerability of the ramp-up dosing schedule in the evaluated disease types.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Confirmed diagnosis of only one of the following: Cohort A a. Marginal Zone Lymphoma i. R/R extranodal, splenic or nodal disease defined as disease that has relapsedafter, or been refractory to, ≥ 1 line of anti-CD20 antibody-basedchemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy forMZL is available per investigator's assessment. ii. Active disease requiring treatment. b. Follicular Lymphoma i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors ofhematopoietic and lymphoid tissue) and defined as disease that has relapsed after,or been refractory to, ≥ 1 line of anti-CD20 antibody-based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for FL is available perinvestigator's assessment. ii. Active disease requiring treatment. c. Diffuse Large B-cell Lymphoma i. R/R DLBCL defined as disease that relapsed after, or been refractory to, at leastone line of anti-CD20 antibody based chemoimmunotherapy for ≥ 2 consecutive cycles,and no effective standard therapy for DLBCL is available per investigator'sassessment. ii. Active disease requiring treatment. d. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Cohort A that has transformed into a moreaggressive lymphoma. Patients with transformation from CLL or SLL (Richter'stransformation) are not eligible for Cohort A. ii. Active disease requiring treatment. Cohorts B and C a. CLL/SLL diagnosis that meets the International Workshop on Chronic LymphocyticLeukemia (IWCLL) criteria: i. R/R disease defined as disease that has relapsed after, or been refractory to, ≥ 1 line of standard therapy for ≥ 2 consecutive cycles, and no effective standardtherapy is available per investigator's assessment. ii. Requiring treatment based on IWCLL criteria.

  2. Measurable disease by computed tomography/magnetic resonance imaging, defined as:

  3. CLL: At least 1 lymph node > 1.5 centimeters (cm) in longest diameter andmeasurable in 2 perpendicular dimensions. For Cohort B, participants should notmeet with the definition of high tumor burden, which is required forparticipants enrolled in Cohort C.

  4. DLBCL, FL, MZL, SLL: At least 1 lymph node > 1.5 cm in longest diameter OR 1extranodal lesion > 1.0 cm in the longest diameter, measurable in 2perpendicular dimensions. For MZL isolated splenomegaly is considered toindicate measurable disease for this study. For SLL, participants in Cohort Bshould not meet with the definition of high tumor burden, which is required forparticipants enrolled in Cohort C.

Exclusion

Key Exclusion Criteria:

  1. Prior malignancy (other than the disease under study) within the past 2 years,except for curatively treated basal or squamous cell skin cancer, superficialbladder cancer, carcinoma in situ of the cervix or breast, or localized Gleasonscore ≤ 6 prostate cancer.

  2. Underlying medical conditions that, in the investigator's opinion, will render theadministration of study drug hazardous or obscure the interpretation of safety orefficacy results.

  3. Known central nervous system involvement by lymphoma/leukemia.

  4. Known plasma cell neoplasm, prolymphocytic leukemia, history of or currentlysuspected Richter's syndrome.

  5. Prior autologous stem cell transplant unless ≥ 3 months after transplant; or priorchimeric cell therapy unless ≥ 6 months after cell infusion.

  6. Prior allogeneic stem cell transplant.

Study Design

Total Participants: 64
Treatment Group(s): 1
Primary Treatment: BGB-11417
Phase: 1
Study Start date:
July 05, 2021
Estimated Completion Date:
June 30, 2026

Study Description

This study will have 3 cohorts for determining a monotherapy MTD and ramp-up schedule: Cohort A, participants with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R NHL); Cohort B, participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with low tumor burden; Cohort C, participants with R/R CLL/SLL with high tumor burden.

Connect with a study center

  • Peking University First Hospital

    Beijing, Beijing Municipality 100034
    China

    Site Not Available

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality 100044
    China

    Site Not Available

  • Peking University First Hospital

    Beijing 1816670, Beijing Municipality 2038349 100034
    China

    Site Not Available

  • Peking University Peoples Hospital

    Beijing 1816670, Beijing Municipality 2038349 100044
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Shenzhen Peoples Hospital

    Shenzhen, Guangdong 518020
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center

    Guangzhou 1809858, Guangdong 1809935 510060
    China

    Site Not Available

  • Shenzhen Peoples Hospital

    Shenzhen 1795565, Guangdong 1809935 518020
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou 1784658, Henan 1808520 450000
    China

    Site Not Available

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

    Wuhan, Hubei 430030
    China

    Site Not Available

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

    Wuhan 1791247, Hubei 1806949 430030
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha 1815577, Hunan 1806691 410013
    China

    Site Not Available

  • First Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou 1886760, Jiangsu 1806260 215006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang 1800163, Jiangxi 1806222 330006
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality 200032
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 200032
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310003
    China

    Site Not Available

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