Study of BGB-11417 in Participants With Leukemia or Lymphoma Who Failed or Were Intolerant To Prior Treatment With Bruton Tyrosine Kinase Inhibitors

• Status: Not yet recruiting
• Trial end date: 2025-01-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of BGB-11417 in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who failed or were intolerant to prior treatment with Bruton tyrosine kinase inhibitors (BTKi)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene

Criteria

Key Inclusion Criteria 1. Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria

1. Have received ≥ 1 prior line of therapy (a line of therapy is considered ≥ 2 cycles of a systemic anticancer regimen), and

2. Have received ≥ 1 kind of adequate BTKi therapy (as monotherapy or in combination with other anticancer agents, consecutive treatment with BTKi for ≥ 8 weeks), and

3. Have documented failure to achieve at least PR-L or documented disease progression on or after the last line of treatment or were intolerant to BTKi when BTKi was used as monotherapy in the last line

2. Participants who require treatment based on the iwCLL 2018 criteria 3. Measurable disease by computed tomography scan (CT)/Magnetic resonance imaging (MRI), defined as ≥ 1 lymph node of > 1.5 cm in the longest diameter or ≥ 1 extranodal lesion of > 1.0 cm in the longest diameter, measurable in ≥ 2 perpendicular dimensions.

4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 5. Life expectancy of > 6 month

Key Exclusion Criteria

1. Prior malignancy 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 low risk (Gleason score ≤ 6) localized prostate cancer

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 plasma cell neoplasm, prolymphocytic leukemia, or a history of or currently suspected Richter's syndrome

4. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion)

5. Prior allogeneic stem cell transplant

Note: Other protocol defined Inclusion/Exclusion criteria may apply