Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Must have received: anti-CD20 monoclonal antibody

Relapsed after or failed to respond to at least one prior line of systemic therapy including anti-CD20 monoclonal antibody and alkylator-containing chemotherapy

Must have received: alkylating agent

Relapsed after or failed to respond to at least one prior line of systemic therapy including anti-CD20 monoclonal antibody and alkylator-containing chemotherapy

Cannot have received: BTK inhibitor

Exception: Participants who discontinued covalent BTK inhibitor therapy due to intolerance will not be excluded.

Participants who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor. Participants who discontinued a covalent BTK inhibitor due to disease progression or relapse.

Cannot have received: CD20/CD3-directed bispecific antibody

Any CD20/CD3-directed bispecific antibodies for treatment of lymphoma

Cannot have received: allogeneic stem cell transplant

Exception: Allowed if >6 months prior, off immunosuppression, and no active GVHD

Allogeneic stem cell transplant (SCT) within 6 months or on active immunosuppression or active graft versus host disease (GVHD)

Cannot have received: solid organ transplantation

Solid organ transplantation

Cannot have received: autologous stem cell transplant

Autologous SCT within 90 days prior to first study treatment

Cannot have received: CAR-T cell therapy

Exception: Allowed if >60 days prior and no ongoing toxicity ≥ grade 2

Chimeric antigen receptor (CAR) T-cell therapy within 60 days before first study treatment or if ongoing toxicity ≥ grade 2

Cannot have received: monoclonal antibody

Use of monoclonal antibodies or antibody-drug conjugates within 4 weeks prior to first study treatment

Cannot have received: antibody-drug conjugate

Use of monoclonal antibodies or antibody-drug conjugates within 4 weeks prior to first study treatment

Cannot have received: radioimmunoconjugate

Use of radioimmunoconjugates within 12 weeks prior to first study treatment

Cannot have received: systemic immunosuppressive medication (cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents)

Exception: Systemic corticosteroid treatment ≤10 mg/day prednisone or equivalent and inhaled corticosteroids are permitted. Acute, low-dose, systemic immunosuppressant medications (e.g., single dose of dexamethasone for nausea or B symptoms) is permitted. Mineralocorticoids for orthostatic hypotension and corticosteroids for adrenal insufficiency are permitted.

Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks or five half-lives (whichever is shorter) prior to first dose of study treatment.

Cannot have received: live, attenuated vaccine

Live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment

Cannot have received: radiation therapy

Exception: If received within 4 weeks, must have at least one measurable lesion outside of the radiation field

Radiotherapy within 2 weeks prior to the first dose of study treatment. If participants have received radiotherapy within 4 weeks prior to the first study treatment administration, participants must have at least one measurable lesion outside of the radiation field