Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
Sponsor: BeiGene
ClinicalTrials ID:NCT05471843
This clinical trial assesses the safety, tolerability, and efficacy of BGB-11417, an oral drug, in patients with relapsed or refractory mantle cell lymphoma. Eligible participants must have a confirmed MCL diagnosis, prior treatments including anti-CD20 therapy and BTK inhibitors, measurable disease, and adequate organ function. The study involves a dose-finding phase followed by an efficacy evaluation.
Patient Parameters
| Parameter | Options |
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Program Overview
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 Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of MCL
- 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).
- 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 0,1 or 2.
- Adequate organ function
Key
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 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.
- 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama At Birmingham Hospital | 35294 | Birmingham | Alabama |
| Medstar Georgetown University Hospital | 20007 | Washington | District of Columbia |
| Fort Wayne Medical Oncology and Hematology | 46804 | Fort Wayne | Indiana |
| Des Moines Oncology Research Association | 50309 | Des Moines | Iowa |
| Tulane Cancer Center | 70112 | New Orleans | Louisiana |
| Luminis Health Anne Arundel Medical Center | 21401 | Annapolis | Maryland |
| Maryland Oncology Hematology, Pa | 21044 | Columbia | Maryland |
| University of Missouri Hospital, Ellis Fischel Cancer Center | 65212 | Columbia | Missouri |
| Nebraska Cancer Specialists | 68803 | Grand Island | Nebraska |
| Dartmouth Cancer Center | 03756 | Lebanon | New Hampshire |
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