Actively Recruiting
A Study to Evaluate Zanubrutinib and Tislelizumab in Progressive Lymphoma Post CAR-T
Led by University Health Network, Toronto · Updated on 2025-06-19
76
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase ll study of participants with large B Cell lymphoma previously treated with anti-CD19 Chimeric antigen receptor (CAR-T) therapy. The purpose of the study is to to evaluate the efficacy of zanubrutinib and tislelizumab in patients with progressive lymphoma post anti-CD 19 CAR-T failure.
CONDITIONS
Official Title
A Study to Evaluate Zanubrutinib and Tislelizumab in Progressive Lymphoma Post CAR-T
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able and willing to provide written informed consent and follow study rules
- Measurable disease with at least one nodal lesion larger than 2.0 cm or extranodal lesion larger than 1.0 cm
- For intervention arm: more than one site of measurable disease
- Relapsed or refractory large B-cell lymphoma after anti-CD19 CAR-T therapy within 6 weeks before enrollment
- For intervention arm: hemoglobin at least 80 g/L at screening
- For intervention arm: platelet count at least 50 x 10^9/L at screening
- For intervention arm: neutrophil count at least 1.0 x 10^9/L at screening
- For intervention arm: performance status 2 or less at screening
- AST and ALT less than 2.5 times the upper limit of normal at screening
- Serum total bilirubin less than 1.5 times upper limit of normal, or less than 3 times upper limit if Gilbert's syndrome
- Creatinine clearance at least 30 mL/min at screening; blood counts may be supported with growth factors or transfusions
You will not qualify if you...
- Life expectancy less than 30 days at enrollment
- Prior treatment with BTK or PD-1 inhibitors
- Previous anaphylactic reaction to monoclonal antibody therapy
- Taking prednisone over 10 mg daily for at least 7 days before study treatment
- Uncontrolled autoimmune diseases
- Active central nervous system lymphoma
- History of allogeneic or organ transplant
- Active bleeding disorders or history of severe bleeding
- Stroke or brain hemorrhage within 180 days before study drug
- Difficulty swallowing oral medication or significant gastrointestinal problems
- Active uncontrolled infections or positive for certain viral infections without control
- Serious heart, lung, or cerebrovascular conditions including recent heart attack or stroke
- Other active cancers within 2 years except certain treated skin or cervical cancers
- Women of childbearing potential not using highly effective contraception during and 90 days after treatment
- Men not vasectomized or not using barrier contraception during and 90 days after treatment
- Major surgery within 4 weeks before study drug
- Live vaccine within 28 days before study drug
- Need for warfarin or vitamin K antagonists
- Severe lung disease or active significant infections
- Conditions requiring high-dose corticosteroids or immunosuppressants within 14 days before treatment
- Contraindications to zanubrutinib or tislelizumab
- Any other illness that may affect safety or study results
- Active or severe autoimmune diseases except certain controlled conditions such as vitiligo or type 1 diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Health Network (UHN)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
J
John Kuruvilla, FRCPC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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