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Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects

About

Brief Summary

This study is directed towards subjects diagnosed with B cell non-Hodgkin lymphomas that has returned (relapsed) or is non responsive to standard treatment (refractory). This is a dose escalation study where subjects are enrolled with each successive group receiving a higher dose of the drug until side effects weighed against benefits of the drug prohibit further increase in dosage (Ascending Dose Cohorts). The study drug IGN002 is a combined protein composed of the standard of care drug rituximab, an antibody that attaches onto non-Hodgkin lymphomas (NHL) cells, linked to Interferon, a protein normally produced in small quantities by the immune system. The hope is that targeting the interferon to NHL cells will slow their growth and activate the subject s immune system to fight the cancer. The combined protein drug IGN002 has never been given to human participants. The main purpose of this phase I study is to test the safety of the study drug IGN002 at different dose levels. We want to find out what effects, good and/or bad, IGN002 has on lymphoma patients and their cancers, and to measure levels of IGN002 in subject s blood. This will allow study doctors to determine the appropriate dosing of IGN002 for the next round (phase II) of clinical trials. We will also assess for preliminary evidence of the ability of the drug to shrink patient s tumors. IGN002is not approved by the U.S. Food and Drug Administration (FDA). It is only available on clinical trials such as this one.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Adult subjects diagnosed with B cell non-Hodgkin lymphomas that has returned (relapsed) or is non responsive to standard treatment (refractory). \n\n For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Inclusion Criteria:

  • Documented history of immunohistochemistry (IHC)-confirmed CD20-positive (with no subsequent history of CD20-negativity) B-cell, NHL, including diffuse large B cell (DLBCL), mantle cell, marginal zone, lymphoplasmacytic, follicular, transformed follicular, or primary mediastinal B cell lymphoma
  • Refractory disease, having failed available therapies
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Life expectancy > 3 months
  • Adequate organ function

Exclusion Criteria:

  • Treatment with an approved or investigational chemotherapy drug within 28 days of Day 1
  • Treatment with an approved or investigational anti-CD20 drug within 28 days of Day 1
  • Treatment with an approved or investigational biologic drug that does not target CD20 within 90 days of Day 1
  • Radiation therapy within 4 weeks of Day 1

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Study Stats
Protocol No.
15-001053
Category
Hematology-Oncology
Oncology
Principal Investigator
Contact
NICOLE SOWDEN
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT02519270
For detailed technical eligibility, visit ClinicalTrials.gov.