Study on BI-1206 and Rituximab for Treating Slow-Growing B-Cell Non-Hodgkin Lymphoma

Sponsor: BioInvent International AB

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03571568

Provider View

This clinical trial is testing a new treatment combining BI-1206, a monoclonal antibody, with rituximab to see if it can help patients with slow-growing B-cell Non-Hodgkin Lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if a new combination of drugs, BI-1206 and rituximab, can effectively treat patients with certain types of slow-growing B-cell Non-Hodgkin Lymphoma (NHL) that have either come back after treatment or have not responded to standard therapies. The trial is divided into two phases to determine the best dose and to evaluate the treatment's effectiveness.

Description

This clinical trial is divided into two main parts: Phase 1 and Phase 2a.

In Phase 1, researchers will test different doses of BI-1206, given either through an IV (intravenous) or under the skin (subcutaneous), in combination with rituximab, to find the safest and most effective dose. Participants will receive one cycle of this combination treatment.

In Phase 2a, the study will expand to include more participants to further evaluate the effectiveness of the best dose identified in Phase 1. Participants who benefit from the treatment after six weeks, showing either complete or partial response or stable disease, will continue to receive maintenance therapy every eight weeks for up to six cycles or one year, whichever comes first.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of B-cell Non-Hodgkin Lymphoma, specifically follicular lymphoma (except grade 3B), mantle cell lymphoma, or marginal zone lymphoma.
  • Have measurable lymph node disease.
  • Willing to undergo biopsies of affected tissue.
  • Have disease that has returned or not responded to standard treatments, including at least one rituximab-based regimen.
  • Have a life expectancy of at least 12 weeks.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have cancer cells that are CD20 positive.
  • Have blood and biochemical levels within specified ranges.

Exclusion Criteria

  • Have had a bone marrow or stem cell transplant within the past 12 months.
  • Have active chronic graft versus host disease.
  • Have cancer affecting the brain or spinal cord.
  • Have transformed lymphoma from a previous slow-growing lymphoma.
  • Have Waldenstrom's Macroglobulinemia or follicular lymphoma grade 3B.
  • Need high doses of steroids during the study.
  • Have allergies to rituximab or BI-1206.
  • Have heart or kidney amyloidosis.
  • Have received recent chemotherapy, radiotherapy, or immunotherapy.
  • Have ongoing side effects from previous treatments.
  • Are pregnant, breastfeeding, or able to become pregnant.
  • Have not recovered from major surgery.
  • Have serious non-cancerous diseases or active infections.
  • Test positive for hepatitis B, hepatitis C, or HIV.
  • Have an active autoimmune disease.
  • Have severe heart disease or other current cancers.

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