A Phase IB, Open-Label, Multicenter, Single Arm Study Evaluating the Preliminary Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Patients With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

Description

The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have failed one prior line of therapy incorporating an anti-cluster of differentiation (CD) 20 antibody (i.e., rituximab) and an anthracycline, and who are transplant or chimeric antigen receptor T-cell (CAR-T) therapy eligible, defined as being medically eligible for intensive platinum-based salvage therapy followed by autologous stem cell transplantation (ASCT) or for CAR-T therapy.

Trial Eligibility

Inclusion Criteria: * Life expectancy ≥ 12 weeks * Histologically confirmed B-cell lymphoma * One line of prior systemic therapy including an anti-CD20 monoclonal antibody (i.e. rituximab) and an anthracycline * Relapsed or refractory disease after first-line chemoimmunotherapy * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Participant must be a candidate for high-dose chemotherapy followed by ASCT or CAR-T therapy Exclusion Criteria: * Treatment with more than one prior line of therapy for DLBCL * Primary mediastinal B-cell lymphoma * Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3 * Peripheral neuropathy assessed to be Grade \> 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment * Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment * Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment * Primary or secondary CNS lymphoma at the time of enrollment or history of CNS lymphoma * Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) * Known history of progressive multifocal leukoencephalopathy * Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia, or as otherwise permitted by inclusion criteria) * Prior solid organ transplantation * Prior allogeneic stem cell transplant * Prior ASCT for lymphoma * Prior autologous stem cell transplant for any indication other than lymphoma, within 5 years from the start of study treatment * Active autoimmune disease requiring treatment * Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 4 weeks prior to first dose of study treatment * Ongoing corticosteroid use \> 30 mg/day of prednisone or equivalent. Participants who received corticosteroid treatment with ≤ 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to Cycle 1 Day 1. Participants may have received a brief (≤ 7 days) course of systemic steroids (≤ 100 mg prednisone equivalent per day) prior to initiation of study therapy for control of lymphoma-related symptoms * Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis * Clinically significant history of cirrhotic liver disease

Study Info

Interventions

Locations Recruiting

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