OncoMatch/Clinical Trials/NCT05833763
A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure.
Is NCT05833763 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Glofitamab and Pirtobrutinib for mantle cell lymphoma.
Treatment: Glofitamab · Pirtobrutinib · Obinutuzumab · Tocilizumab — The goal of this clinical trial is to evaluate the safety and response of combining Pirtobrutinib and Glofitimab in patients with relapsed MCL. The main question it aims to answer are: * Will additive and synergistic effects be observed when using a combination of glofitamab and pirtobrutinib? * Will this combination be safe and lead to high complete- and remission rates with no residual disease? Pirtobrutinib will be given to all participants as an oral tablet for the duration of the entire study. Participants will receive other treatment in 3 phases: 1. Treatment Ramp-Up 1. Treatment with Obinutuzumab by Intravenous (IV) 2. An initial dose level of Glofitamab will evaluate step-up dosing. If excessive adverse events are observed, a lower initial dose will be used. 2. Fixed course combination phase: Treatment with Glofitamab by IV 3. Maintenance phase: Glofitamab is discontinued. 200mg oral daily
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BTK inhibitor
Prior therapy with a BTK inhibitor alone or in combination and: Progression or relapse post BTK inhibitor or Failed to achieve PR following 12 weeks of BTK inhibitor therapy
Cannot have received: pirtobrutinib (pirtobrutinib)
Prior treatment with pirtobrutinib
Cannot have received: CD20xCD3 bispecific antibody
demonstrated refractoriness to a CD20xCD3 bispecific antibody
Cannot have received: allogeneic stem cell transplant
Exception: if >12 months from enrollment and no chronic GVHD or immunosuppressive therapy (for safety cohort)
For patients enrolling on the safety cohort, a history of allogeneic transplantation within 12 months of enrolment or ongoing chronic GVHD or immunosuppressive therapy
Cannot have received: autologous stem cell transplant or CAR-T therapy
Exception: if >6 weeks from enrollment
Autologous SCT or CAR-T therapy within 6 weeks of enrolment
Lab requirements
Blood counts
Hemoglobin ≥ 80g/L (transfusion permitted); ANC ≥ 1.0x10^9/L (G-CSF supported permitted); Platelets ≥ 75 X 10^9/L (≥ 50 X 10^9/L if marrow involvement or splenomegaly, must be platelet transfusion independent for 7 days prior to first dose of obinutuzumab)
Kidney function
Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault)
Liver function
ALT and AST ≤ 3X ULN (≤ 5X ULN if liver involvement); Total bilirubin ≤ 1.5X ULN (≤ 5X ULN if liver involvement and/or Gilbert's Disease)
Cardiac function
LVEF ≥ 40%; no unstable angina/ACS within 2 months; no MI within 3 months; no NYHA Class III/IV heart failure; no uncontrolled/symptomatic arrhythmias; QTcF ≤ 470 msec
Adequate coagulation, defined as aPTT and PT not greater than 1.5xULN, unless laboratory abnormality is explained by concomitant anticoagulant medication, a lupus anticoagulant, or a factor deficiency not associated with an increased bleeding risk, as determined by the investigator. Adequate liver function: ALT and AST less than or equal to 3X ULN, or less than or equal to 5X ULN if documented liver involvement; Total bilirubin less than or equal to 1.5X ULN or less than or equal to 5X ULN if documented liver involvement and/or Gilbert's Disease. Adequate renal function: Creatinine clearance greater than or equal to 30mls/minute according to Cockroft-Gault formula. Adequate haematological parameters: Haemoglobin greater than or equal to 80g/L (transfusion support permitted); Absolute neutrophil count greater than or equal to 1.0x10^9/L (May be G-CSF supported); Platelets greater than or equal to 75 X 10^9/L. OR platelets greater than or equal to 50 X 10^9/L if documented marrow involvement or splenomegaly (must be platelet transfusion independent for 7 days prior to first dose of obinutuzumab). Significant cardiovascular disease defined as: Unstable angina or acute coronary syndrome within 2 months of registration; History of myocardial infarction within 3 months prior to registration; Documented LVEF by any method of = 40% during screening; Grade 3 or higher NYHA functional classification system of heart failure; Uncontrolled or symptomatic arrhythmias. Prolongation of the QT interval corrected for heart rate (QTcF) greater than 470 msec on at least 2/3 consecutive electrocardiograms (ECGs), and mean QTcF greater than 470 msec on all 3 ECGs, during Screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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