Mantle Cell LymphomaPhase 2NCT07341191
Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
A Phase 2 study testing Zanubrutinib, Sonrotoclax and CAR-T Cell Therapy in people with Mantle Cell Lymphoma, run by Canadian Cancer Trials Group at 5 sites in Canada.
Trial summary
The purpose of this study is to evaluate the effects of adding two oral medications (sonrotoclax plus zanubrutinib) to standard of care chimeric antigen receptor (CAR-T) cell therapy in participants with mantle cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Zanubrutinib, Sonrotoclax and CAR-T Cell Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesCanada
- Study dates
- 24 Aug 2026to 31 Dec 2030
- 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
- Have histologically confirmed mantle cell lymphoma that is relapsed or refractory after at least one prior line of systemic therapy
- Eligible for and planned to receive Health Canada approved CAR-T.
- Have a formalin fixed paraffin embedded tumour tissue block available and must have provided informed consent for the release of the block.
- Presence of radiologically documented disease.
- Measurable disease (one site bidimensionally measurable).
- Age ≥ 18 years.
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- Have an ECOG performance status of 0, 1 or 2
- Anticipated life expectancy of ≥ 6 months
- Adequate hematologic and biochemical parameters
- Must have received prior systemic therapy as shown below;
- At least one line of systemic therapy including a Bruton's Tyrosine Kinase inhibitor (BTKi).
- Participants who have previously received venetoclax, sonrotoclax, or any other BCL2 inhibitor (BCL2i) are eligible as long as progressive disease did not occur within 6 months of the last dose of BCL2i. Participants with progressive disease during BCL2i therapy or within 6 months of last dose are not eligible.
- Participants must enter the study while on a BTKi or enroll to a substudy of the protocol to receive zanubrutinib for a minimum duration prior to enrolling to the main study.
- Participants previously exposed to zanubrutinib are eligible irrespective of response to treatment.
- Participants entering the study while on a BTKi must have their BTKi switched to zanubrutinib supplied through the study.
- Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.
- Adequate washout must be followed per protocol.
- Prior high-dose myelosuppresive radiation is permitted ≥28 prior to enrollment.
- Previous major surgery is permitted ≥28 days prior to enrollment. Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
Who cannot join
- • Participants on active anticancer therapy for other advanced or metastatic malignancies.
- Concurrent treatment with other anti-cancer therapy
- Serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol.
- Known hypersensitivity to the study drug(s) or their components.
- Prior CD19-directed CAR-T at any time, autologous hematopoietic cell transplantation within 6 weeks, or allogeneic hematopoietic cell transplantation within 3 months. Allogeneic hematopoietic cell transplantation recipients must be free of clinically-significant graft-versus-host disease (GvHD) and must be off immunosuppression for GvHD for at least 4 weeks before enrollment.
- Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or unstable angina congestive heart failure or myocardial infarction within the previous year.
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- Active, uncontrolled bacterial, fungal, or viral infection within 14 days prior to enrollment
- Pregnant or breastfeeding women.
- Inability to discontinue use of moderate or strong CYP3A inducers or inhibitors during the ramp-up treatment period with sonrotoclax.
- Live vaccination within 4 weeks prior to enrollment or who plan to receive a live vaccine during treatment or within 90 days post last dose.
- Inability to swallow capsules or tablets or have any diseases significantly affecting GI function
- Active central nervous system (CNS) disease; Participants with stable CNS disease are eligible.
- Growth factors within 28 days prior to enrollment.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Robert Puckrin, 403 944-5222
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Vladimir Sapon-Cousineau, 780 432-8697
- Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
Amaris Balitsky, 905 387-9495
- Recruiting
University Health Network
Toronto, Ontario, M5G 2M9
Sita Bhella
- Recruiting
BCCA - Vancouver
Vancouver, British Columbia, V5Z 4E6
Diego Villa Restrepo, 604 877-6000 ext. 2740
About this study
Official title: A Phase II Study of Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
The purpose of this study is to evaluate the effects of adding two oral medications (sonrotoclax plus zanubrutinib) to standard of care chimeric antigen receptor (CAR-T) cell therapy in participants with mantle cell lymphoma.
Read the detailed description
Combining sonrotoclax (a next-generation BCL-2 inhibitor) with zanubrutinib (a selective BTK inhibitor) in mantle cell lymphoma (MCL)-is expected to be driven by strong biologic synergy, complementary mechanisms, and more durable responses without chemotherapy. Patients participating in this study must already be planning, and be eligible for CAR-T cell therapy outside of this protocol. CAR-T will be administered according to local or provincial guidelines.
If a patient decides to take part in this study, the patient will first get zanubrutinib (if not on it before starting the study), then during the induction phase they will get a combination of sonrotoclax (with a ramp-up dosing schedule) plus zanubrutinib followed by CAR-T cell therapy, followed zanubrutinib alone/ maintenance.
After finishing study treatment, and even if patients stop treatment early, the study doctor will continue to follow the patient's condition for the rest of their life or until all study results are known
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Zanubrutinib, Sonrotoclax, CAR-T Cell Therapy
- Keywords
- CAR-T, Relapsed, Refractory, BTK inhibitor, BCL2 inhibitor
- Medical subject headings
- Lymphoma, Mantle-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
assigned at enrollment
SonrotoclaxDrug
assigned at enrollment
CAR-T Cell TherapyBiological
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Zanubrutinib + Sonrotoclax | Experimental | Not described Receives: Drug: Zanubrutinib; Drug: Sonrotoclax; Biological: CAR-T Cell Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response post CAR-T
Measured: 3.5 years
Secondary outcomes (4)
Objective Response Rate assessed by the Lugano Classification
Measured: 3.5 years
1 year Progression-Free Survival
Measured: 4 years
Overall Survival
Measured: 4 years
Number and Severity of Adverse Events
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start24 Aug 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- BeOne Medicines
- Responsible party
- Sponsor
- Investigators
- Diego Villa, Study chair, BCCA-Vancouver Cancer CentreRobert Puckrin, Study chair, Tom Baker Cancer Centre, Calgary, AB Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341191
- Sponsor's protocol ID
- I245
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2026
- Last updated
- 14 Oct 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
- ClinicalTrials.gov ID
- NCT07341191
- Acronym / sponsor ID
- I245
- Conditions
- Mantle Cell Lymphoma
- Keywords
- CAR-T, Relapsed, Refractory, BTK inhibitor, BCL2 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- BeOne Medicines
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Jan 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.
The purpose of this study is to evaluate the effects of adding two oral medications (sonrotoclax plus zanubrutinib) to standard of care chimeric antigen receptor (CAR-T) cell therapy in participants with mantle cell lymphoma.
Detailed description
Combining sonrotoclax (a next-generation BCL-2 inhibitor) with zanubrutinib (a selective BTK inhibitor) in mantle cell lymphoma (MCL)-is expected to be driven by strong biologic synergy, complementary mechanisms, and more durable responses without chemotherapy. Patients participating in this study must already be planning, and be eligible for CAR-T cell therapy outside of this protocol. CAR-T will be administered according to local or provincial guidelines.
If a patient decides to take part in this study, the patient will first get zanubrutinib (if not on it before starting the study), then during the induction phase they will get a combination of sonrotoclax (with a ramp-up dosing schedule) plus zanubrutinib followed by CAR-T cell therapy, followed zanubrutinib alone/ maintenance.
After finishing study treatment, and even if patients stop treatment early, the study doctor will continue to follow the patient's condition for the rest of their life or until all study results are known
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zanubrutinib + Sonrotoclax | Experimental | Drug: Zanubrutinib, Drug: Sonrotoclax, Biological: CAR-T Cell Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Have histologically confirmed mantle cell lymphoma that is relapsed or refractory after at least one prior line of systemic therapy
- Eligible for and planned to receive Health Canada approved CAR-T.
- Have a formalin fixed paraffin embedded tumour tissue block available and must have provided informed consent for the release of the block.
- Presence of radiologically documented disease.
- Measurable disease (one site bidimensionally measurable).
Key exclusion criteria (13 listed)
- • Participants on active anticancer therapy for other advanced or metastatic malignancies.
- Concurrent treatment with other anti-cancer therapy
- Serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol.
- Known hypersensitivity to the study drug(s) or their components.
- Prior CD19-directed CAR-T at any time, autologous hematopoietic cell transplantation within 6 weeks, or allogeneic hematopoietic cell transplantation within 3 months. Allogeneic hematopoietic cell transplantation recipients must be free of clinically-significant graft-versus-host disease (GvHD) and must be off immunosuppression for GvHD for at least 4 weeks before enrollment.
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 |
|---|---|---|
| Zanubrutinibassigned at enrollment | Drug | Zanubrutinib + Sonrotoclax |
| Sonrotoclaxassigned at enrollment | Drug | Zanubrutinib + Sonrotoclax |
| CAR-T Cell TherapyStandard of Care | Biological | Zanubrutinib + Sonrotoclax |
Primary outcome
Complete response post CAR-T
Time frame: 3.5 years
4 secondary outcomes
Objective Response Rate assessed by the Lugano Classification
Time frame: 3.5 years
1 year Progression-Free Survival
Time frame: 4 years
Overall Survival
Time frame: 4 years
Number and Severity of Adverse Events
Time frame: 3.5 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 14 Oct 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.
Diego Villa study chair
BCCA-Vancouver Cancer Centre
Robert Puckrin study chair
Tom Baker Cancer Centre, Calgary, AB Canada
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib, Sonrotoclax and CAR-T Cell Therapy in people with Mantle Cell Lymphoma, run by Canadian Cancer Trials Group at 5 sites in Canada.
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 19 inclusion and 13 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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 Annette Hay (613-533-6430, ahay@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response post CAR-T (time frame: 3.5 years). 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 14 Oct 2026.