Non Hodgkin Lymphoma Clinical Trial
Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma
The primary objective of this study is to determine the safety and tolerability of GS-0189 (formerly FSI-189) as monotherapy and in combination with rituximab in participants with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL).
The study will consist of 5 parts: 1) an initial Monotherapy Dose Escalation (MDE) part, 2) a Combination Dose Escalation (CDE) part, 3) a Pharmacokinetic (PK) Evaluation part, 4) an Alternate Schedule Evaluation (ASE) part and 5) a diffuse large B-cell lymphoma (DLBCL) Expansion part.
Key Inclusion Criteria:
DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) relapsed/refractory (R/R) to at least 2 prior lines of therapy. Prior autologous hematopoietic cell transplantation and individuals with transformed lymphomas are permitted. Individuals must be at least 3 months out from prior autologous hematopoietic cell transplantation. Individuals with indolent lymphomas must be candidates for systemic treatment in the judgment of the treating physician.
In the DLBCL Expansion part: DLBCL that is relapsed or refractory to at least 2 prior lines of therapy. Prior autologous hematopoietic cell transplantation and individuals with transformed lymphomas are permitted.
Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.
For the DLBCL expansion cohort, disease must be measurable for response per Lugano criteria. For all other cohorts, disease must be measurable or assessable for response per Lugano criteria.
Exhibit acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests.
Key Exclusion Criteria:
Individuals with active brain metastases (Individuals with stable treated central nervous system (CNS) lesions who are off corticosteroid therapy for at least 3 weeks are not considered active.
Individuals with Burkitt's lymphoma.
Prior treatment with a chimeric antigen receptor (CAR) T-cell therapy ≤ 90 days from first dose of study drug.
Prior allogeneic stem cell transplant.
Previous anticancer therapy including chemotherapy, hormonal therapy, and investigational agents within 3 weeks or at least 4 half-lives (up to a maximum of 4 weeks), whichever is longer, prior to first dose of study drug.
Known active or chronic hepatitis B or C infection or human immunodeficiency virus.
Prior treatment with CD47 or signal regulatory protein alpha (SIRPα)-targeting agents.
Hypersensitivity to the active substance, to murine proteins, or to any of the other excipients of rituximab
Significant medical diseases or conditions, as assessed by the Investigator and Sponsor, that would substantially increase the risk:benefit ratio of participating in the study.
Rituximab-containing cohorts only: Receipt of live/attenuated vaccines within 30 days of rituximab dosing
Has persisting toxicity related to prior therapy of Grade > 1 in severity per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 5 Locations for this study
Birmingham Alabama, 35233, United States
Duarte California, 91010, United States
Sarasota Florida, 34232, United States
Saint Louis Missouri, 63110, United States
Oklahoma City Oklahoma, 73104, United States
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