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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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Tislelizumab

    Drug

    Tislelizumab 200mg intravenously every 3 weeks

  • Zanubrutinib

    Drug

    Zanubrutinib 160 mg oral twice daily

  • Tislelizumab + Zanubrutinib

    Drug

    Tislelizumab 200mg intravenously day 1 of each cycle every 3 weeks + Zanubrutinib 160 mg oral twice daily starts day 1 of each cycle

Treatment groups

76 Participants
are divided into 4 treatment groups
Group A: TislelizumabExperimental treatment 1 intervention
Group B: ZanubrutinibExperimental treatment 1 intervention
Group C: Tislelizumab + ZanubrutinibExperimental treatment 1 intervention
Group D: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

determine the best overall response rate (ORR)

To determine the best overall response rate (ORR) of the combination of zanubrutinib and tislelizumab as well as standard of care in patients previously treated with anti-CD19 CAR-T cell therapy. The best ORR is defined as the proportion of patients with a complete response (CR) or a partial response (PR) during the study, as determined by the investigator using Lugano 2014 criteria.

Time frame
2 years

Secondary outcomes

1

Duration of response (DOR)

DOR is defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression or relapse, as determined by the investigator using Lugano 2014 criteria, or death from any cause, whichever occurs first

Time frame
2 years
2

Progression free survival (PFS)

PFS is defined as the date of enrollment until disease progression, relapse or death from any cause

Time frame
2 years
3

Event free survival (EFS)

EFS is defined as the date of enrollment until disease progression, relapse, death, or discontinuation of treatment for one of three reasons: toxicity, patient preference, initiation of new treatment without documented progression

Time frame
2 years
4

Overall survival (OS)

OS is define as the date of enrollment to death from any cause

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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