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Active Not Recruiting NCT04077723

A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Conditions: Lymphoma, Non-Hodgkin

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 498
Sponsor: Hoffmann-La Roche

Location: City of Hope Medical Center Pasadena California

Summary

This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of englumafusp alfa (RO7227166) in participants with relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL). Englumafusp alfa will be administered by intravenous (IV) infusion in combination with obinutuzumab and in combination with glofitamab. A fixed dose of obinutuzumab (Gpt; pre-treatment) will be administered up to seven days prior to the first administration of englumafusp alfa and seven days prior to the first administration of glofitamab. This entry-into-human study is divided into a dose-escalation stage (Part I and Part II) and a dose expansion stage (Part III).

Eligibility Criteria

Inclusion Criteria: * History or status of a histologically-confirmed hematological malignancy that is expected to express CD19 and CD20; relapse after or failure to respond to at least one prior treatment regimen; no available treatment options that are expected to prolong survival (Part I and II); relapsed after or failed to respond to only one prior systemic treatment regimen (Part III) * Must have at least one measurable target lesion (\>/= 1.5 cm) in its largest dimension by computed tomography scan * Able and willing to provide a fresh biopsy from a safely accessible site, per Investigator's determination, providing the participant has more than one measurable target lesion * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or \/= 12 weeks * Adverse events from prior anti-cancer therapy must have resolved to Grade \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04077723). StuddyBuddy aggregates publicly available trial information.