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

Phase 1

Recruiting

• Conditions: Refractory Mantle Cell Lymphoma; MedDRA version: 21.1Level: PTClassification code: 10026801Term: Mantle cell lymphoma refractory Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-500687-35-00
• Lead Sponsor: Beigene Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Histologically confirmed diagnosis of MCL, Prior systemic treatments for MCL (at least one line of anti-cluster of differentiate 20 (CD20) based immune or chemoimmunotherapy and at least one line of treatment with covalent or non-covalent Bruton Tyrosine Kinase Inhibitor (BTKi) as mono- or combination therapy), relapsed/refractory disease, Presence of measurable disease, Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, Adequate organ function

Exclusion Criteria

Known central nervous system involvement by lymphoma, 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., Prior exposure to a Bcl-2 inhibitor (eg, venetoclax/ABT-199)., Prior autologous stem cell transplant within the last 3 months; or prior chimeric 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., Clinically significant cardiovascular disease., Major surgery or significant injury = 4 weeks prior to start of study treatment., Active fungal, bacterial or viral infection requiring systemic treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified