A Study to Evaluate Zanubrutinib and Tislelizumab in Progressive Lymphoma Post CAR-T

Sponsor
University Health Network, Toronto
Study ID
NCT06167785
Phase
PHASE2
Status
Recruiting
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Conditions

  • Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Dec 13, 2023
Start date
Jun 4, 2025
Status verified
Jun 2026
Primary completion
Apr 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
76 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Tislelizumab
    Tislelizumab 200mg intravenously every 3 weeks - initial safety run-in period
  • Experimental: Zanubrutinib
    Zanubrutinib 160 mg oral twice daily - initial safety run-in period
  • Experimental: Tislelizumab + Zanubrutinib
    Tislelizumab 200mg intravenously day 1 of each cycle every 3 weeks * Zanubrutinib 160 mg oral twice daily starts day 1 of each cycle - expanded cohort
  • No Intervention: Standard of Care
    Patients will receive standard of care, which is up to the investigator's discretion. This may include, but not limited to, palliative chemotherapy, steroids and/or radiation as deemed appropriate.

Primary Outcome Measure

determine the best overall response rate (ORR) [ Time Frame: 2 years ]

Central Contacts

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