Active not recruitingPHASE1, PHASE2INTERVENTIONAL

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

This research study is looking into a new medication called BGB-11417 (also known as sonrotoclax) for individuals with a type of cancer called mantle cell lymphoma. This lymphoma has either returned after initial treatment or hasn't responded to previous therapies. The study has two main parts. The first part focuses on understanding the drug's safety, any side effects, and finding the best dose to use. The second part then checks how effective this chosen dose is at treating the lymphoma. This is designed for adults aged 18 and over, of any gender, who meet specific health criteria.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

BeOne Medicines

Enrolment target

125

Start

05 Sep 2022

Estimated completion

31 Jan 2027

Mantle Cell Lymphoma Refractory Mantle Cell Lymphoma (MCL)Relapsed Mantle Cell Lymphoma

Results

Results from this study

Posted September 2026

Results have been published for this study.

Primary outcome

Part 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

DLTs included the following events without a clear alternative cause other than study drug: Hematologic Toxicity: * Grade ≥ 3 febrile neutropenia; * Grade ≥ 3 thrombocytopenia lasting \> 7 days or resulting in clinically significant bleeding; * Any Grade ≥ 4 hematological toxicities, except for Grade 4 neutropenia lasting ≤ 7 days with or without treatment, Grade 4 lymphopenia, or Grade 4 leukopenia. Nonhematologic Toxicity: • Any Grade ≥ 3 nonhematologic toxicity with the following exceptions: * Laboratory tumor lysis syndrome (TLS) defined by the Howard criteria that resolves (≤ Grade 1 or baseline) in ≤ 3 days; * Individual TLS-related laboratory adverse events that resolve (≤ Grade 1or baseline) in ≤ 3 days with or without treatment; * Grade 3 gastrointestinal toxicity that resolves to ≤ Grade 2 following therapeutic intervention in ≤ 7 days; * Asymptomatic biochemical laboratory abnormalities that resolve (≤ Grade 1 or baseline) in ≤ 7 days with or without supportive care.

Full results on the registry

What is this study about?

This study is focused on people who have mantle cell lymphoma, which is a type of cancer that starts in white blood cells. Specifically, it's for those whose lymphoma has either come back after treatment (this is called 'relapsed') or hasn't responded well to previous treatments (this is called 'refractory'). The main goal is to test a new medicine called BGB-11417, which is also known as sonrotoclax.

The study has two main parts. In the first part, doctors will give different doses of BGB-11417 to a small group of patients. Their main aim here is to find out if the medicine is safe and what the highest dose is that people can comfortably take without too many side effects. This will help them decide on the best dose to use going forward. They will also be looking for any common side effects.

Once they've found the best dose, the second part of the study will begin. In this part, more patients will receive the chosen dose. The doctors will then closely watch to see how well the medicine works at shrinking the lymphoma or stopping its growth. This helps researchers understand if BGB-11417 could be a helpful new treatment option for people living with mantle cell lymphoma.

Key takeaways

This study is for adults with mantle cell lymphoma that has returned or not responded to prior treatments.
It's testing a new drug called BGB-11417 (sonrotoclax).
The study aims to find a safe dose and see how effective the drug is.
Participation involves taking the study drug and regular health checks.
You must have already tried specific previous treatments for your lymphoma.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or older and have a confirmed diagnosis of mantle cell lymphoma. Your lymphoma must have either come back or not responded to previous treatments. You must also have already received certain standard treatments, including specific types of immunotherapy and at least two different Bruton's Tyrosine Kinase (BTK) inhibitor medications.

Additionally, your lymphoma needs to be 'measurable,' meaning doctors can see and track it, for example, on scans. They'll also need a sample of your lymphoma tissue, either an old one or you might need a new small procedure to get one. You should be generally well enough to take part in a study like this, as assessed by a doctor, and have healthy organ function.

There are also some reasons why you might not be able to join. For example, if your lymphoma has spread to your brain or spinal cord, or if you've had certain other cancers recently. If you've previously taken a similar type of drug to BGB-11417 (called a BCL-2 inhibitor), or had certain stem cell or CAR T-cell treatments recently, you also can't participate. Other reasons include significant heart problems, recent major surgery, or an active infection requiring strong medication.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have mantle cell lymphoma that has come back or not responded to previous treatments?
Have you already had at least two different types of BTK inhibitor medications and certain anti-CD20 treatments?
Is your lymphoma visible and trackable (measurable)?
Do you generally feel well enough to participate in a study, and are your organs functioning adequately?
Have you *not* had a similar drug (like venetoclax) before, or recent major surgeries/transplants?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study drug, BGB-11417. Initially, the drug might be given with a slow increase in dose over time to see how you tolerate it. You will have regular visits to the clinic so doctors can monitor your health, check for side effects, and see how the treatment is working. These visits will likely involve physical exams, blood tests, and scans to assess your lymphoma. The total duration of your participation will depend on how you respond to the treatment and the study's specific design, but it will involve ongoing assessments and follow-up.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't yet widely available, which might help your mantle cell lymphoma when other treatments haven't worked. However, like all medications, BGB-11417 may have side effects, and some could be serious or unexpected. The study doctors will carefully monitor you for any issues. Even though you are starting a new treatment, there is no guarantee it will improve your condition. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (65)

University of Alabama At Birmingham Hospital
Verified postcode
Birmingham, United States
Fort Wayne Medical Oncology and Hematology
Verified postcode
Fort Wayne, United States
Tulane Cancer Center
Verified postcode
New Orleans, United States
Maryland Oncology Hematology, Pa
Verified postcode
Columbia, United States
Hackensack University Medical Center
Verified postcode
Hackensack, United States
The University of Texas Md Anderson Cancer Center
Verified postcode
Houston, United States
Hospital Aleman
Approximate
Ciudad Autonoma Buenos Aires, Argentina
University Hospitals Leuven
Verified postcode
Leuven, Belgium
Hospital Erasto Gaertner
Verified postcode
Curitiba, Brazil
Hospital Mae de Deus
Verified postcode
Porto Alegre, Brazil
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Verified postcode
Ribeirão Preto, Brazil
Oncoclinicas Rio de Janeiro Sa
Verified postcode
Rio de Janeiro, Brazil

Common questions

What is BGB-11417?

BGB-11417, also known as sonrotoclax, is a new experimental drug being tested for mantle cell lymphoma.

What is 'relapsed or refractory' mantle cell lymphoma?

This means your lymphoma has either come back after treatment or hasn't responded to previous treatments.

Will I get this drug if I join the study?

Yes, if you meet the study criteria, you will receive BGB-11417 as part of the trial. This is not a placebo-controlled study.

What phase is this study in?

This study is in Phase 1 and Phase 2. Phase 1 focuses on safety and dosing, while Phase 2 looks at how well the drug works.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and it will not affect your future medical care.