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New treatment option for Large B-cell Lymphoma
Official title A Study to Evaluate Zanubrutinib and Tislelizumab in Progressive Lymphoma Post CAR-T
ClinicalTrials.gov ID: NCT06167785
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for large b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Able and willing to provide written informed consent and to comply with the study protocol
- Radiologically measurable disease (≥ 1 nodal lesion \> 2.0 cm in the longest diameter, and/or extranodal lesion \> 1.0cm in the longest diameter)
- Intervention arm: Radiological measurable disease per inclusion criterion #3 with more than one site of disease.
- Relapse or refractory Large B cell Lymphoma post-CD19 directed CAR-T cell therapy within 6 weeks prior to enrollment (histological confirmation...
You likely can't join if
- Life expectancy \< 30 days at the time of enrollment
- Prior exposure to BTK or PD-1 inhibitor at any time prior to enrollment
- Prior anaphylactic reaction to monoclonal antibody therapy at any time prior to enrollment
- Intervention arm: On higher than physiologic doses (10mg daily) of prednisone daily at least 7 days prior to initiation of trial treatment. SOC arm...
- Uncontrolled autoimmune disease
- Known active CNS involvement disease
See the full eligibility criteria
Who can join
- Age ≥ 18 years
- Able and willing to provide written informed consent and to comply with the study protocol
- Radiologically measurable disease (≥ 1 nodal lesion \> 2.0 cm in the longest diameter, and/or extranodal lesion \> 1.0cm in the longest diameter)
- Intervention arm: Radiological measurable disease per inclusion criterion #3 with more than one site of disease.
- Relapse or refractory Large B cell Lymphoma post-CD19 directed CAR-T cell therapy within 6 weeks prior to enrollment (histological confirmation highly recommended although not mandatory)
- Intervention arm: Hemoglobin ≥ 80 g/L at screening\
- Intervention arm: Platelet count ≥ 75 x 109/L at screening\
- Intervention arm: Neutrophil count ≥ 1.0 x 109/L at screening\
- Intervention arm: ECOG performance status ≤ 2 at screening
- AST and ALT \< 2.5 x ULN at screening
- Serum total bilirubin \< 1.5 x ULN, except in patients with documented Gilberts syndrome at screening
- Creatinine clearance ≥ 30 mL/min as estimated by Cockcroft-gault equation at screening \ Counts can be supported with growth factors or transfusions as per standard transfusion protocols.
What rules you out
- Life expectancy \< 30 days at the time of enrollment
- Prior exposure to BTK or PD-1 inhibitor at any time prior to enrollment
- Prior anaphylactic reaction to monoclonal antibody therapy at any time prior to enrollment
- Intervention arm: On higher than physiologic doses (10mg daily) of prednisone daily at least 7 days prior to initiation of trial treatment. SOC arm: On prednisone for symptom management only.
- Uncontrolled autoimmune disease
- Known active CNS involvement disease
- History of prior allogeneic transplant or organ transplant
- Active bleeding or history of bleeding diathesis including, but not limited to,
- History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
- History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
- Difficulty with or unable to swallow oral medication, or known conditions that would significantly affect gastrointestinal function that would limit absorption of oral medication
- History of chronic or active, uncontrolled bacterial, viral or fungal infection; human T-cell lymphotropic virus type 1 seropositive status.
- Serologic status reflecting active viral hepatitis B or C infection as follows:
- 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 (\< 20IU), and if...
- Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable.
- Individuals with known active HIV infection are eligible if CD4 and viral titres are controlled
- Any serious intercurrent illness, life threatening condition, organ system dysfunction including:
- (1) Clinically significant cardiovascular including:
- prolonged QTc \> 480ms,
- history of Mobitz II second degree or third degree heart block without a permanent pacemaker in situ,
- uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure reading on 2 separate occasions showing systolic BP \> 170 mmHg and/or diastolic BP \> 105mmHg at screening,
- uncontrolled or history of symptomatic arrhythmias (ie. sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes),
- congestive heart failure or NYHA class ≥ 3,
- myocardial infarction within 6 months prior to enrollment;
- (2) History of significant cerebrovascular events including stroke or intracranial hemorrhage within 6 months prior to enrollment
- History of other active malignancies within 2 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of cervix; localized basal cell or squamous cell carcinoma of skin; or previous...
- Female patients of childbearing potential must practice highly effective methods (Section 6.7.1.1) of contraception initiated prior to first dose of study drug, for the duration of the study, and for ≥ 120 days after...
- Male patients are eligible if vasectomized or if they agree to the use of barrier contraception with highly effective methods during the study treatment period and for ≥ 120 days after the last dose of zanubrutinib or...
- Major surgery within 4 weeks of the first dose of study drug
- Vaccination with a live vaccine within 28 days prior to the first dose of study drug
- Patient requires treatment with warfarin or other vitamin K antagonists
- Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, congestive obstructive pulmonary disease).
- History of interstitial lung disease or non-infectious pneumonitis or pulmonary fibrosis, except for those induced by radiation therapy.
- Active and symptomatic fungal, bacterial, and/or viral infection; human T-cell lymphotropic virus type 1 seropositive status.
- Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any study endpoint.
- Active autoimmune diseases or history of severe autoimmune diseases; these include but are not limited to a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy...
- A condition requiring systemic treatment with either corticosteroids (\> 20 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration, except for PCNSL and...
- Major surgery in the past 4 weeks prior to the first day of screening.
- Patients with contraindications for zanubrutinib and Tislelizumab
- Pregnant or lactating women.
- Hypersensitivity to zanubrutinib and Tislelizumab or any of the other ingredients of the applicable study drugs
- Patients with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not constituting a likely safety risk
- With uncontrolled diabetes or \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥ Grade 3 hypoalbuminemia ≤ 14 days before randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.