A Study to Evaluate Zanubrutinib and Tislelizumab in Progressive Lymphoma Post CAR-T
ConditionLarge B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tislelizumab
- Zanubrutinib
- Tislelizumab + Zanubrutinib
Treatment groups
76 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov