MCLPhase 2NCT06463691
Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients
A Phase 2 study testing BGB-11417, BGB-3111 and CD20 in people with MCL, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a an open-label, multi-center, single-arm study to evaluate the efficacy and safety of sonrotoclax, zanubrutinib and CD20mab in untreated MCL patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MCL
- What is being tested?
- BGB-11417, BGB-3111 and CD20
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be ≥ 18 years of age.
- Subject must have a confirmed Mantle Cell Lymphoma (MCL) diagnosis according to WHO (2008) criteria.
- Previously untreated MCL
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
- Nonsterile men and women of child-bearing potential must agree to use highly effective contraceptives (e.g., condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or sterilized partner) while on study; this should be maintained for 90 days after the last dose of study drug.
- Subject must have adequate bone marrow function at Screening as follows:
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- a.Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L (neutropenia due to marrow infiltration may be supported by growth factors);
- b. Platelets ≥ 75,000/mm3 (or ≥ 50,000/mm3 for patients with bone marrow involvement of lymphoma) within 7 days
- Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening as follows:
- aPTT and PT not to exceed 1.5 × the upper limit of normal (ULN); Serum creatinine not to exceed 2 x ULN, and a calculated creatinine clearance of at least 50 mL/min using the Cockcroft-Gault equation or a 24-hour urine collection;
- AST or ALT ≤ 3.0 × the upper normal limit (ULN) of institution's normal range; Bilirubin ≤ 1.5 × ULN. Subjects with documented Gilbert's Syndrome may have a bilirubin > 1.5 × ULN.
- Written informed consent form according to GCP and national regulations.
Who cannot join
- Subject has known central nervous system involvement by MCL.
- 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.
- Receiving any treatment with a moderate CYP3A4 inhibitor or strong CYP3A4 inhibitor or inducer within 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug or requiring long-term use of strong CYP3A4 inhibitors or inducers.
- Prior ASCT 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.
- Major surgery within 4 weeks of screening.
- Clinically significant cardiovascular disease including the following:
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- Myocardial infarction within 6 months before screening
- Unstable angina within 3 months before screening
- New York Heart Association class III or IV congestive heart failure
- History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation)
- QT interval corrected based on Fridericia's formula (QTcF) > 480 msec.
- History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
- Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHg at screening.
- Prior exposure to a BCL2 inhibitor (e.g., venetoclax/ABT-199).
- Prior exposure to a BTK inhibitor (e.g., ibrutinib, zanubrutinib).
- History of hypersensitivity to excipient(s) of the sonrotoclax tablet.
- Patients with unresolved hepatitis B or C infection or known HIV-positive infection：
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (< 20 IU/mL), and if they are willing to undergo monitoring for HBV reactivation.
- Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (< 15 IU/mL), and if they are willing to undergo monitoring for HCV reactivation.
- Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- Pregnant or lactating women.
- History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug.
- Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Huilai Zhang, 00862223359337, info@tjmuch.com
About this study
Official title: An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy and Safety of Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients
This is a an open-label, multi-center, single-arm study to evaluate the efficacy and safety of sonrotoclax, zanubrutinib and CD20mab in untreated MCL patients.
Read the detailed description
The benefits of efficacy and survival of immunotherapy regimen in TN MCL is limited, and not all patients are fit for receiving chemotherapy. Considering the balance of toxicity and efficacy, a chemo-free regimen will be a trend in 1L MCL patients. The study is to explore the sonrotoclax, zanubrutinib and CD20mab combination regimen for TN MCL.
- Conditions
- MCL
- Being tested
- BGB-11417, BGB-3111, CD20
- Keywords
- MCL, Sonrotoclax, Zanubrutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-11417Drug
Also called Sonrtotoclax
Sonrotoclax, orally, 320 mg once daily following a weekly ramp-up schedule
BGB-3111Drug
Also called Zanubrutinib
Zanubrutinib, orally, 320 mg total daily dose
CD20Drug
CD20mab is recommened as Rituximab as per the protocol, other CD20mab is also allowed.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Sonrotoclax, orally, 320 mg once daily following ramp-up. Zanubrutinib, orally, 320 mg total daily dose. CD20mab, which is recommended Rituximab, 375mg/m2, from C1 to C12 Receives: Drug: BGB-11417; Drug: BGB-3111; Drug: CD20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR (complete response) rate at cycle 12 by investigator (INV).
Complete response rate (CRR) of the study population from the initiation of the first cycle treatment. CRR is defined as the proportion of patients that achieved the best response of CR, determined by INV.
Measured: From enrollment to the end of treatment at the end of cycle 12 (each cycle is 28 days)
Secondary outcomes (2)
ORR (Overall response rate)
ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR), as determined by INV -PFS defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by INV.
Measured: From enrollment to the end of treatment at the end of cycle 36 (each cycle is 28 days)
Overall survival (OS)
Overall survival (OS) is defined as the duration from the date of initiation of the first cycle of treatment to the date of death because of any cause.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Aug 2024
- Primary completionDec 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCLStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sonrotoclax, Zanubrutinib and CD20mab
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463691
- Sponsor's protocol ID
- BGB-11417- 2003-IIT
- Status last verified
- May 2025
- First submitted
- 5 Jun 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy and Safety of Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients
- ClinicalTrials.gov ID
- NCT06463691
- Acronym / sponsor ID
- BGB-11417- 2003-IIT
- Conditions
- MCL
- Keywords
- MCL, Sonrotoclax, Zanubrutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a an open-label, multi-center, single-arm study to evaluate the efficacy and safety of sonrotoclax, zanubrutinib and CD20mab in untreated MCL patients.
Detailed description
The benefits of efficacy and survival of immunotherapy regimen in TN MCL is limited, and not all patients are fit for receiving chemotherapy. Considering the balance of toxicity and efficacy, a chemo-free regimen will be a trend in 1L MCL patients. The study is to explore the sonrotoclax, zanubrutinib and CD20mab combination regimen for TN MCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sonrotoclax, Zanubrutinib and CD20mab
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: BGB-11417, Drug: BGB-3111, Drug: CD20Sonrotoclax, orally, 320 mg once daily following ramp-up. Zanubrutinib, orally, 320 mg total daily dose. CD20mab, which is recommended Rituximab, 375mg/m2, from C1 to C12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject must be ≥ 18 years of age.
- Subject must have a confirmed Mantle Cell Lymphoma (MCL) diagnosis according to WHO (2008) criteria.
- Previously untreated MCL
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
- Nonsterile men and women of child-bearing potential must agree to use highly effective contraceptives (e.g., condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or sterilized partner) while on study; this should be maintained for 90 days after the last dose of study drug.
Key exclusion criteria (23 listed)
- Subject has known central nervous system involvement by MCL.
- 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.
- Receiving any treatment with a moderate CYP3A4 inhibitor or strong CYP3A4 inhibitor or inducer within 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug or requiring long-term use of strong CYP3A4 inhibitors or inducers.
- Prior ASCT 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.
- Major surgery within 4 weeks of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGB-11417Also: SonrtotoclaxSonrotoclax, orally, 320 mg once daily following a weekly ramp-up schedule | Drug | Treatment arm |
| BGB-3111Also: ZanubrutinibZanubrutinib, orally, 320 mg total daily dose | Drug | Treatment arm |
| CD20CD20mab is recommened as Rituximab as per the protocol, other CD20mab is also allowed. | Drug | Treatment arm |
Primary outcome
CR (complete response) rate at cycle 12 by investigator (INV).
Time frame: From enrollment to the end of treatment at the end of cycle 12 (each cycle is 28 days)
Complete response rate (CRR) of the study population from the initiation of the first cycle treatment. CRR is defined as the proportion of patients that achieved the best response of CR, determined by INV.
2 secondary outcomes
ORR (Overall response rate)
Time frame: From enrollment to the end of treatment at the end of cycle 36 (each cycle is 28 days)
Overall survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BGB-11417, BGB-3111 and CD20 in people with MCL, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huilai Zhang, MD, PhD (0086-22-23359337, info@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR (complete response) rate at cycle 12 by investigator (INV). (time frame: From enrollment to the end of treatment at the end of cycle 12 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.