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Clinical Trials in the UK / NCT05471843
Active, not recruiting Phase 1/2

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

NCT05471843 · tracked via the Priya Life Science UK tracker
Sponsor
BeiGene
Phase
Phase 1/2
Started
2022-09-05
Last updated
2025-09-09

Condition(s) studied

Mantle Cell LymphomaRefractory Mantle Cell Lymphoma (MCL)Relapsed Mantle Cell Lymphoma

Investigational drug(s) / intervention(s)

BGB-11417

BGB-11417: Administered orally

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 1. Histologically confirmed diagnosis of MCL 2. Prior systemic treatments for MCL (at least one line of anti-cluster of differentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least one kind 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 undergo fresh tumor biopsy 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2. 7. Adequate organ function Key Exclusion Criteria: 1. Known central nervous system involvement by lymphoma 2. Prior malignancy other than MCL within the past 3 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. 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 autologous chimeric antigen receptor T-cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-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.

Primary outcome measure(s)

Trial sites (104)

FacilityCityRegionStatus
University of Alabama At Birmingham Hospital Birmingham Alabama
Medstar Georgetown University Hospital Washington D.C. District of Columbia
Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
Des Moines Oncology Research Association Des Moines Iowa
Tulane Cancer Center New Orleans Louisiana
Luminis Health Anne Arundel Medical Center Annapolis Maryland
Maryland Oncology Hematology, Pa Columbia Maryland
University of Missouri Hospital, Ellis Fischel Cancer Center Columbia Missouri
Nebraska Cancer Specialists Grand Island Nebraska
Dartmouth Cancer Center Lebanon New Hampshire
Hackensack University Medical Center Hackensack New Jersey
Novant Health Hematology Charlotte Charlotte North Carolina
The University of Texas Md Anderson Cancer Center Houston Texas
Hospital Aleman Buenos Aires Argentina
Az Sint Jan Brugge Bruges Belgium
Universitair Ziekenhuis Gent Ghent Belgium
University Hospitals Leuven Leuven Belgium
AZ DELTA Roeselare Belgium
Hospital Erasto Gaertner Curitiba Brazil
Hospital Mae de Deus Porto Alegre Brazil
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp Ribeirão Preto Brazil
Oncoclinicas Rio de Janeiro Sa Rio de Janeiro Brazil
Instituto Americas Ensino, Pesquisa E Inovacao Rio de Janeiro Brazil
Hospital Sao Rafael (Rede Dor) Salvador Brazil
Hospital Beneficencia Portuguesa de Sao Paulo São Paulo Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo São Paulo Brazil
Accamargo Cancer Center São Paulo Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular São Paulo Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo Brazil
Qeii Health Science Center Halifax Nova Scotia
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital Hefei Anhui
China Japan Friendship Hospital Beijing Beijing Municipality
Beijing Cancer Hospital Beijing Beijing Municipality
Beijing Friendship Hospital, Capital Medical University(Tongzhou) Beijing Beijing Municipality
Fujian Cancer Hospital Fuzhou Fujian
Sun Yat Sen University Cancer Center Guangzhou Guangdong
Guangdong Provincial Peoples Hospital Huifu Branch Guangzhou Guangdong
Jiangmen Central Hospital Jiangmen Guangdong
The Tumor Hospital Affiliated to Guangxi Medical University Nanning Guangxi
Cancer Hospital of Guizhou Medical University Guiyang Guizhou

+ 64 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05471843 on ClinicalTrials.gov ↗ ← All trials in the UK