Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    75
  • sponsor
    Gilead Sciences
Updated on 31 July 2021
hodgkin's disease
rituximab
flow cytometry
cell transplantation
gilbert's syndrome
neutrophil count
follicular lymphoma
diffuse large b-cell lymphoma
b-cell lymphoma
marginal zone lymphoma
large b-cell lymphoma
indolent lymphoma
refractory non-hodgkin's lymphoma
non-hodgkin's lymphoma refractory

Summary

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).

Description

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.

Details
Condition Lymphoma, Lymphoma, Non-Hodgkin's Lymphoma, non-hodgkin's lymphoma (nhl)
Treatment Rituximab, FSI-189, GS-0189
Clinical Study IdentifierNCT04502706
SponsorGilead Sciences
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

DLBCL, follicular lymphoma (FL), or marginal zone lymphoma (MZL) expressing CD20 by immunohistochemistry (IHC) or flow cytometry, 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: Individuals must have de novo or transformed DLBCL expressing CD20 by IHC or flow cytometry, 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

Exclusion Criteria

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
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
Prior allogeneic stem cell transplant
Rituximab-containing cohorts only: Receipt of live/attenuated vaccines within 30 days of rituximab dosing
Known active or chronic hepatitis B or C infection or human immunodeficiency virus
Prior treatment with CD47 or signal regulatory protein alpha (SIRP)-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. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, severely immunocompromised state, and congestive heart failure New York Heart Association Classes II to IV
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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