Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma

A Phase Ib, Multicenter, Open-label Study of HCD122 Administered Intravenously in Combination With Bendamustine in Patients With CD40+ Follicular Lymphoma Who Are Refractory to Rituximab

This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.

Inclusion Criteria:

• Confirmed diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization [REAL/WHO] classification
• Documented CD40+ follicular lymphoma
• Measurable lesion
• Refractory to rituximab
• Prior treatment with at least 1 chemotherapeutic regimen
• 18 years or older
• WHO Performance Status grade 0, 1, or 2
• Life expectancy > 3 months
• Obtained written informed consent

Exclusion Criteria:

• Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. DLBCL)
• History of another primary malignancy that is currently clinically significant or currently requires active intervention
• Prior allogeneic stem cell transplantation
• Prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
• Impaired cardiac function or clinically significant cardiac disease
• History of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis
• History of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment.
• Known diagnosis of human immunodeficiency virus (HIV) infection
• Evidence of previous hepatitis viral infection such as hepatitis B or hepatitis C
• Ongoing corticosteroid use (>10 mg/day prednisone or equivalent)
• Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply