OncoMatch/Clinical Trials/NCT07418190
Efficacy and Safety of Zanubrutinib, Rituximab, and Lenalidomide (ZR²) in Combination With Tislelizumab for Relapsed/Refractory Follicular Lymphoma
Is NCT07418190 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies tislelizumab + zanubrutinib + rituximab + lenalidomide for relapsed/refractory follicular lymphoma.
Treatment: tislelizumab + zanubrutinib + rituximab + lenalidomide — This is a prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of zanubrutinib, rituximab, and lenalidomide (ZR²) in combination with tislelizumab in patients with relapsed/refractory follicular lymphoma who have relapsed or are refractory after ≥1 prior systemic therapy. After successful screening, enrolled patients will receive 6 treatment cycles (21 days per cycle). Disease response will be assessed by CT/PET-CT during treatment and after completion of induction. Patients who achieve CR/PR/SD will proceed to the maintenance phase; patients who do not achieve at least SD (i.e., fail to reach CR/PR/SD) during induction will discontinue the study. Patients with CR/PR/SD after induction will receive maintenance therapy with zanubrutinib plus tislelizumab until disease progression, unacceptable toxicity, or completion of 1 year of maintenance. Efficacy and safety assessments will be performed per protocol. Tumor response will be assessed by site investigators according to the 2014 Lugano criteria, including determination of response status, date of response, and date of progression/relapse.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-CD20 monoclonal antibody therapy
Received at least two prior lines of systemic therapy, including anti-CD20 monoclonal antibody therapy
Cannot have received: BTK inhibitor (zanubrutinib)
Prior exposure to zanubrutinib or other BTK inhibitors
Cannot have received: hematopoietic stem cell transplantation
Prior hematopoietic stem cell transplantation
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L (≥1,500/µL); Platelets ≥75,000/µL, with no platelet transfusion within 14 days prior to first dosing; Hemoglobin ≥10.0 g/dL (6.2 mmol/L), with no blood transfusion within 21 days prior to first dosing
Kidney function
serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min calculated by the Cockcroft-Gault formula
Liver function
Total bilirubin ≤1.5 × ULN; for patients with documented Gilbert syndrome: total bilirubin ≤3 × ULN with predominantly indirect hyperbilirubinemia. AST and ALT ≤3 × ULN.
Adequate hepatic function: Total bilirubin ≤1.5 × ULN; for patients with documented Gilbert syndrome: total bilirubin ≤3 × ULN with predominantly indirect hyperbilirubinemia. AST and ALT ≤3 × ULN. Adequate hematologic function: ANC ≥1.5 × 10⁹/L (≥1,500/µL) Platelets ≥75,000/µL, with no platelet transfusion within 14 days prior to first dosing on Cycle 1 Day 1 Hemoglobin ≥10.0 g/dL (6.2 mmol/L), with no blood transfusion within 21 days prior to first dosing on Cycle 1 Day 1 Adequate renal function: serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min calculated by the Cockcroft-Gault formula (see Appendix 14), for patients in whom serum creatinine may not adequately reflect renal function per investigator judgment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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