Intermediate-to-High-Risk Mantle Cell LymphomaPhase 1NCT07548255
The Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined With Obinutuzumab in MCL
A Phase 1 study testing Sonrotoclax, Zanubrutinib Combined with Obinutuzumab in people with Intermediate-to-High-Risk Mantle Cell Lymphoma and the Efficacy and Safety, run by Ruijin Hospital at 1 site in China.
Trial summary
A Single-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined with Obinutuzumab in the First-Line Treatment of Newly Diagnosed Intermediate-to-High-Risk Mantle Cell Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermediate-to-High-Risk Mantle Cell Lymphoma, the Efficacy and Safety
- What is being tested?
- Sonrotoclax, Zanubrutinib Combined with Obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 1 Mar 2029
- Phase
- Phase 1
- 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
- Age ≥18 years.
- Histologically confirmed, previously untreated mantle cell lymphoma (MCL), with at least one of the following high-risk features:
- Blastoid or pleomorphic morphology;
- Ki-67 ≥30%;
- TP53 mutation or deletion;
- 17p deletion;
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- High-risk MIPI group with an expected survival >3 months.
- Laboratory criteria meeting the following requirements:
- Absolute neutrophil count ≥1,000/mm³ or ≥1.0 × 10⁹/L, platelet count ≥50,000/mm³ or ≥50 × 10⁹/L, and hemoglobin ≥8 g/dL;
- Creatinine clearance ≥50 mL/min (calculated using the standard Cockcroft-Gault formula);
- Serum albumin ≥3.0 g/dL; total bilirubin ≤1.5 × the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, or ≤5.0 × ULN in cases of hepatic lymphoma involvement; serum amylase or lipase ≤ULN;
- International normalized ratio (INR) ≤1.5 × ULN or activated partial thromboplastin time (aPTT) ≤1.5 × ULN; for patients receiving warfarin anticoagulation therapy, INR may be between 2 and 3;
- Cardiac function: left ventricular ejection fraction (LVEF) ≥50%.
Who cannot join
- Contraindications to any of the study drugs.
- Known history of clinically significant liver disease, including viral or other hepatitis or cirrhosis (hepatitis B defined as positive hepatitis B core antibody [HBcAb] with HBV-DNA above the ULN; active hepatitis C defined as positive HCV antibody-patients with negative HCV-RNA may be enrolled).
- Human immunodeficiency virus (HIV) infection.
- Congestive heart failure (New York Heart Association [NYHA] Class >2); history of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to enrollment.
- Congenital long QT syndrome or QTc >480 ms (QTc must be calculated using Fridericia's formula: QTcF = QT/(RR)^0.33).
- History of other malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, carcinoma in situ of the breast, or other second primary malignancies that were curatively treated and have had no recurrence within 5 years.
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- Pregnant or breastfeeding women, or those planning to become pregnant during the study period (fertile men and women must agree to use effective contraception during the study and for 30 days after the last dose of study treatment, such as dual-barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. Postmenopausal women and surgically sterilized women are exempt).
- Prior history of significant neurological or psychiatric disorders, or history of psychotropic drug abuse or substance abuse.
- Clinically significant active infection.
- Inability to take oral medications, difficulty swallowing, chronic diarrhea, intestinal obstruction, or other conditions that may affect drug administration or absorption.
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
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200000
Weili Zhao, 021-64370045, zhao.weili@yahoo.com
About this study
Official title: A Single-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of Sonrotoclax and Zanubrutinib Combined With Obinutuzumab in the First-Line Treatment of Newly Diagnosed Intermediate-to-High-Risk Mantle Cell Lymphoma
A Single-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined with Obinutuzumab in the First-Line Treatment of Newly Diagnosed Intermediate-to-High-Risk Mantle Cell Lymphoma
- Being tested
- Sonrotoclax, Zanubrutinib Combined with Obinutuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonrotoclax, Zanubrutinib Combined with ObinutuzumabDrug
The treatment regimen was as follows: In cycle 1 (C1), obinutuzumab 1000 mg was administered intravenously on day 1 (D1); sotoroclax was given at 80 mg on D2, 160 mg on D3, and 320 mg on D4; zanubrutinib was administered at 160 mg twice daily (BID). Each cycle was defined as 28 days. From cycles 2 to 6 (C2-C6), patients received obinutuzumab 1000 mg intravenously on D1, sotoroclax 320 mg once daily, and zanubrutinib 160 mg BID.
| Study group | Role | What they receive |
|---|---|---|
| Sonrotoclax, Zanubrutinib Combined with Obinutuzumab treatment | Experimental | Not described Receives: Drug: Sonrotoclax, Zanubrutinib Combined with Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
The percentage of participants with a complete response at the end of Cycle 6 was determined on the basis of investigator assessments according to the Lugano Classification for Response Criteria in Lymphoma
Measured: At the end of Cycle 6 (each cycle is 28 days)
Secondary outcomes (4)
Overall survival
Overall survival (OS) was measured from the date of diagnosis to the date of death or the last follow-up.
Measured: 2 years after enrollment
Overall response rate
The percentage of participants with overall response was determined on the basis of investigator assessments according to the Lugano Classification for Response Criteria in Lymphoma
Measured: Overall Response Rate At the end of Cycle 6 (each cycle is 28 days)
Progression free survival
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first.
Measured: 2 years after enrollment
Treatment-Related Adverse Events
An adverse event is any untoward medical occurrence in a participant receiving a pharmaceutical product that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease that is temporally associated with the use of a pharmaceutical product, whether or not it is considered related to the pharmaceutical product. Preexisting conditions that worsen during a study are also considered adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: From enrollment to study completion, a maximum of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate-to-High-Risk Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548255
- Sponsor's protocol ID
- Solide
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of Sonrotoclax and Zanubrutinib Combined With Obinutuzumab in the First-Line Treatment of Newly Diagnosed Intermediate-to-High-Risk Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07548255
- Acronym / sponsor ID
- Solide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 23 Apr 2026 (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.
A Single-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined with Obinutuzumab in the First-Line Treatment of Newly Diagnosed Intermediate-to-High-Risk Mantle Cell Lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonrotoclax, Zanubrutinib Combined with Obinutuzumab treatment | Experimental | Drug: Sonrotoclax, Zanubrutinib Combined with Obinutuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 years.
- Histologically confirmed, previously untreated mantle cell lymphoma (MCL), with at least one of the following high-risk features:
- Laboratory criteria meeting the following requirements:
Key exclusion criteria (10 listed)
- Contraindications to any of the study drugs.
- Known history of clinically significant liver disease, including viral or other hepatitis or cirrhosis (hepatitis B defined as positive hepatitis B core antibody [HBcAb] with HBV-DNA above the ULN; active hepatitis C defined as positive HCV antibody-patients with negative HCV-RNA may be enrolled).
- Human immunodeficiency virus (HIV) infection.
- Congestive heart failure (New York Heart Association [NYHA] Class >2); history of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to enrollment.
- Congenital long QT syndrome or QTc >480 ms (QTc must be calculated using Fridericia's formula: QTcF = QT/(RR)^0.33).
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 |
|---|---|---|
| Sonrotoclax, Zanubrutinib Combined with ObinutuzumabThe treatment regimen was as follows: In cycle 1 (C1), obinutuzumab 1000 mg was administered intravenously on day 1 (D1); sotoroclax was given at 80 mg on D2, 160 mg on D3, and 320 mg on D4; zanubrutinib was administered at 160 mg twice daily (BID). Each cycle was defined as 28 days. From cycles 2 to 6 (C2-C6), patients received obinutuzumab 1000 mg intravenously on D1, sotoroclax 320 mg once daily, and zanubrutinib 160 mg BID. | Drug | Sonrotoclax, Zanubrutinib Combined with Obinutuzumab treatment |
Primary outcome
Complete response rate
Time frame: At the end of Cycle 6 (each cycle is 28 days)
The percentage of participants with a complete response at the end of Cycle 6 was determined on the basis of investigator assessments according to the Lugano Classification for Response Criteria in Lymphoma
4 secondary outcomes
Overall survival
Time frame: 2 years after enrollment
Overall response rate
Time frame: Overall Response Rate At the end of Cycle 6 (each cycle is 28 days)
Progression free survival
Time frame: 2 years after enrollment
Treatment-Related Adverse Events
Time frame: From enrollment to study completion, a maximum of 3 years.
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 23 Apr 2026.
- Individual participant dataSharing planned: No
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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 1 study testing Sonrotoclax, Zanubrutinib Combined with Obinutuzumab in people with Intermediate-to-High-Risk Mantle Cell Lymphoma and the Efficacy and Safety, run by Ruijin 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 13 inclusion and 10 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: opening soon, as of the sponsor's last update on 23 Apr 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Weili Zhao (+86 02164370045, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: At the end of Cycle 6 (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 23 Apr 2026.