Testing Zanubrutinib and Tislelizumab for Progressive Large B-Cell Lymphoma After CAR-T Therapy A Phase II Study of Combination and Monotherapy Treatments

What this Trial Is About

Researchers are evaluating the effectiveness and safety of zanubrutinib and tislelizumab in adults with large B-cell lymphoma that has progressed after treatment with anti-CD19 CAR-T therapy. This phase II study focuses on patients who have already received extensive prior treatments and aims to find better options for those with lymphoma that no longer responds to CAR-T therapy. The study is divided into two parts an initial safety run-in period and an expanded cohort phase. In the run-in period, 10 patients receive either zanubrutinib orally twice daily or tislelizumab intravenously every three weeks to evaluate safety and tolerability. After confirming safety, the expanded cohort phase begins where patients receive a combination of both drugs for up to 34 cycles about 2 years unless there is unacceptable toxicity or disease progression. Patients unable to join the intervention arms can receive standard care, which may include chemotherapy, steroids, or radiation. Participants will undergo regular assessments including imaging to measure disease response and safety evaluations. Researchers will monitor overall response rate as the primary outcome over two years, along with secondary outcomes such as duration of response, progression-free survival, event-free survival, and overall survival. The study includes ongoing safety monitoring and allows participants to continue treatment as long as it is tolerated and effective, with participation lasting up to approximately two years.

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