Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies
NCT ID: NCT04883957
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
64 participants
INTERVENTIONAL
2021-07-05
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: R/R NHL
Participants with R/R NHL, including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), or transformed NHL, will receive oral BGB-11417 until the MTD (or maximum ascending dose \[MAD\]) and the RP2D can be determined.
BGB-11417
Film-coated tablets administered orally as specified in the treatment arm.
Cohort B: R/R CLL/SLL (low tumor burden)
Participants with low tumor burden R/R CLL/SLL will receive oral BGB-11417 until the MTD (or MAD) and the RP2D can be determined.
BGB-11417
Film-coated tablets administered orally as specified in the treatment arm.
Cohort C: R/R CLL/SLL (high tumor burden)
Participants in this cohort will not be enrolled until the RP2D for Cohort B is established. Participants will be treated with the monotherapy ramp-up schedule and the RP2D established in Cohort B.
BGB-11417
Film-coated tablets administered orally as specified in the treatment arm.
Interventions
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BGB-11417
Film-coated tablets administered orally as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Cohort A
a. Marginal Zone Lymphoma
i. R/R extranodal, splenic or nodal disease 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 MZL 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 of hematopoietic 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 per investigator'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 least one line of anti-CD20 antibody based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for DLBCL is available per investigator's assessment.
ii. Active disease requiring treatment.
d. Transformed indolent B-cell NHL
i. Any lymphoma otherwise eligible for Cohort A that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) 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 Lymphocytic Leukemia (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 standard therapy is available per investigator's assessment.
ii. Requiring treatment based on IWCLL criteria.
2. Measurable disease by computed tomography/magnetic resonance imaging, defined as:
1. CLL: At least 1 lymph node \> 1.5 centimeters (cm) in longest diameter and measurable in 2 perpendicular dimensions. For Cohort B, participants should not meet with the definition of high tumor burden, which is required for participants enrolled in Cohort C.
2. DLBCL, FL, MZL, SLL: At least 1 lymph node \> 1.5 cm in longest diameter OR 1 extranodal lesion \> 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions. For MZL isolated splenomegaly is considered to indicate measurable disease for this study. For SLL, participants in Cohort B should not meet with the definition of high tumor burden, which is required for participants enrolled in Cohort C.
Exclusion Criteria
2. Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results.
3. Known central nervous system involvement by lymphoma/leukemia.
4. Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome.
5. Prior autologous stem cell transplant unless ≥ 3 months after transplant; or prior chimeric cell therapy unless ≥ 6 months after cell infusion.
6. Prior allogeneic stem cell transplant.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Lu Zhang, M.D.
Role: STUDY_DIRECTOR
BeiGene (Suzhou) Co., Ltd.
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Shenzhen Peoples Hospital
Shenzhen, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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BGB-11417-102
Identifier Type: -
Identifier Source: org_study_id
CTR20211017
Identifier Type: REGISTRY
Identifier Source: secondary_id