Status:
ACTIVE_NOT_RECRUITING
Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies
Lead Sponsor:
BeiGene
Conditions:
Mature B-cell Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 (RP...
Detailed 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 wit...
Eligibility Criteria
Inclusion
- Key
- 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 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.
- Measurable disease by computed tomography/magnetic resonance imaging, defined as:
- 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.
- 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.
- Key
Exclusion
- Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer.
- 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.
- Known central nervous system involvement by lymphoma/leukemia.
- Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome.
- Prior autologous stem cell transplant unless ≥ 3 months after transplant; or prior chimeric cell therapy unless ≥ 6 months after cell infusion.
- Prior allogeneic stem cell transplant.
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04883957
Start Date
July 5 2021
End Date
April 1 2026
Last Update
December 19 2025
Active Locations (11)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
2
Peking University Peoples Hospital
Beijing, Beijing Municipality, China, 100044
3
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
4
Shenzhen Peoples Hospital
Shenzhen, Guangdong, China, 518020