Study of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, efficacy and exposure to TRM-1 in subjects with relapsed or refractory Non-Hodgkin's Lymphoma (NHL).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Genome Sciences Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Mapatumumab

Criteria

Primary Inclusion Criteria:

• Relapsed or refractory histologically confirmed Non-Hodgkin's Lymphoma

• Previously treated with at least 1 therapeutic regimen and relapsed or progressed or failed to achieve a response after the last regimen

• 18 years of age or older

Primary Exclusion Criteria:

• Received a non-FDA approved investigational agent within the last 4 weeks

• Received cancer therapies (chemotherapy, biological therapy [including hormonotherapy], radiation therapy or immunosuppressants within the last 3 weeks, 8 weeks for monoclonal antibodies, radioimmunotherapy or nitrosourea

• Eligible for a hematopoietic stem cell transplant (HSCT) or have had an autologous HSCT within the last 16 weeks

• Prior history of an allogeneic HSCT

• HIV, AIDS-related lymphoma, central nervous system (CNS) lymphoma, Hepatitis-B or Hepatitis-C

• Infection requiring antibiotics within the last 4 weeks

• Major surgery within the last 4 weeks

• Pregnant or breast-feeding women

• History of other cancers within the past 5 years