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

Human Genome Sciences

Status and phase: Completed; Phase 2

Conditions: Lymphoma, Non-Hodgkin

Treatments: Drug: TRAIL-R1 mAb (TRM-1; HGS-ETR1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00094848

TRM1-HM01

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)