Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies

A Phase IA/II, Multi-center, Open-label Study of HCD122 Administered Intravenously Once Weekly for Four Weeks in Adult Patients With Advanced Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies (CHIR-12.12-LYM-01)

This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.

Inclusion criteria:

Patients may be included in the study if they meet all of the following criteria:

• Patients must have confirmed diagnosis of HL or NHL (follicular, marginal zone / MALT, diffuse large B-cell, or mantle cell) per REAL/WHO classification
• Patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy)
• Patients must be ≥ 18 years
• Patients must have life expectancy > 3 months
• Patient must have adequate laboratory results
• Patients must have WHO Performance Status grade 0, 1, or 2
• Patients must have at least one site of measurable disease
• Patients must have discontinued any previous monoclonal antibody or radioimmunotherapy, and must have recovered fully from the side effects of that treatment prior to beginning study treatment.
• Patients must be willing and able to sign the informed consent form and comply with the study protocol

Exclusion criteria:

Patients will be excluded from the study if they meet any of the following criteria:

• Patients who have been treated with any anti-CD40 antibody
• Patients who have received prior allogeneic stem cell transplant
• Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
• Patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis
• Women of child-bearing potential (WCBP) who are pregnant or breast feeding.

Other protocol-defined inclusion/exclusion criteria may apply