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ACTIVE NOT RECRUITING Phase 1

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

NCT05471843 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG BGB-11417

Study Locations (20)

Other

  • Hospital Aleman — Buenos Aires
  • Az Sint Jan Brugge — Bruges
  • Universitair Ziekenhuis Gent — Ghent
  • University Hospitals Leuven — Leuven
  • AZ DELTA — Roeselare
  • Hospital Erasto Gaertner — Curitiba
  • Hospital Mae de Deus — Porto Alegre

Maryland

  • Luminis Health Anne Arundel Medical Center — Annapolis
  • Maryland Oncology Hematology, Pa — Columbia

Alabama

  • University of Alabama At Birmingham Hospital — Birmingham

District of Columbia

  • Medstar Georgetown University Hospital — Washington D.C.

Indiana

  • Fort Wayne Medical Oncology and Hematology — Fort Wayne

Iowa

  • Des Moines Oncology Research Association — Des Moines

Louisiana

  • Tulane Cancer Center — New Orleans

Missouri

  • University of Missouri Hospital, Ellis Fischel Cancer Center — Columbia

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2022-09-05
Est. Completion 2027-01-31
Phase Phase 1

Sponsor

BeiGene

91 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05471843

The ClinicalTrials.gov registry entry for NCT05471843 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BeiGene, which has 91 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention — of which BGB-11417 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05471843 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Maryland, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05471843 about?

NCT05471843 is a clinical study titled "Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma". 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 monothe...

What is the current status of trial NCT05471843?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2022-09-05. Estimated completion is 2027-01-31.

What conditions does trial NCT05471843 study?

This clinical trial studies the following conditions: Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05471843?

The interventions under investigation include: BGB-11417 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05471843?

This trial is sponsored by BeiGene, which has 91 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05471843 being conducted?

This trial has 20 study locations across Alabama, District of Columbia, Indiana, Iowa, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial