Actively Recruiting
Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
Led by Canadian Cancer Trials Group · Updated on 2026-05-14
40
Participants Needed
2
Research Sites
235 weeks
Total Duration
On this page
Sponsors
C
Canadian Cancer Trials Group
Lead Sponsor
B
BeOne Medicines
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have confirmed mantle cell lymphoma that has returned or not responded after at least one prior systemic therapy
- Eligible for and planned to receive Health Canada approved CAR-T therapy
- Have a formalin fixed paraffin embedded tumor tissue block available and consented for its release
- Have radiologically documented disease
- Have measurable disease at one site (measurable in two dimensions)
- Are 18 years of age or older
- Have an ECOG performance status of 0, 1, or 2
- Have an anticipated life expectancy of at least 6 months
- Have adequate blood and biochemical test results
- Have received at least one prior systemic therapy including a Bruton's Tyrosine Kinase inhibitor (BTKi)
- If previously treated with venetoclax, sonrotoclax, or other BCL2 inhibitors, must not have had disease progression within 6 months of last dose
- Must be on a BTKi or enroll in a substudy to receive zanubrutinib before joining the main study
- Previous zanubrutinib exposure is allowed regardless of response
- If currently on a BTKi, must switch to study-supplied zanubrutinib
- Must have recovered to grade 1 or less from all reversible side effects of prior treatments
- Must follow adequate washout periods as per protocol
- Prior high-dose myelosuppressive radiation allowed if more than 28 days before enrollment
- Previous major surgery allowed if more than 28 days before enrollment
- Participants of childbearing potential must agree to use effective contraception
You will not qualify if you...
- Currently receiving active anticancer treatment for other advanced or metastatic cancers
- Receiving other anti-cancer treatments concurrently
- Have serious illnesses or medical conditions preventing study management
- Known allergy to study drugs or their components
- Prior CD19-directed CAR-T therapy at any time
- Autologous stem cell transplant within 6 weeks or allogeneic transplant within 3 months
- Allogeneic transplant recipients must be free from significant graft-versus-host disease and off immunosuppression for at least 4 weeks
- Untreated or uncontrolled heart conditions including symptomatic dysfunction or recent major cardiac events
- Active, uncontrolled infections within 14 days before enrollment
- Pregnant or breastfeeding women
- Unable to stop moderate or strong CYP3A inducers or inhibitors during sonrotoclax ramp-up
- Received live vaccine within 4 weeks before enrollment or planning live vaccine during treatment or 90 days after last dose
- Unable to swallow capsules or tablets or have significant gastrointestinal disorders
- Active central nervous system disease; stable CNS disease allowed
- Received growth factors within 28 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
BCCA - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Not Yet Recruiting
2
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
A
Annette Hay
CONTACT
L
Laura Pearce
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here