A Study of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

• Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
• Nature of dose-limiting toxicities (DLTs) [ Time Frame: 21 days ] [ Designated as safety issue: No ]

• Incidence of adverse events [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
• Nature of adverse events [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
• Severity of adverse events [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
• Incidence of anti-therapeutic antibodies (ATAs) against DCDS4501A [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

This is a Phase I, multicenter, open-label, dose-escalation study of DCDS4501A administered as a single agent by IV infusion to patients with relapsed or refractory hematologic malignancies. In Phase Ib, patients will receive DCDS4501A in combination with rituximab.

• Drug: DCDS4501A
  Escalating intravenous dose
• Drug: rituximab
  375 mg/m2 iv, Day 1 of each 21-day cycle

• Experimental: A
  Intervention: Drug: DCDS4501A
• Experimental: Phase Ib
  Interventions:

  • Drug: DCDS4501A
  • Drug: rituximab

Inclusion Criteria:

• Life expectancy of at least 12 weeks
• History of one of the following histologically-documented hematologic malignancy for which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL), Grade 3b FL, diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL)
• All patients (NHL and B-CLL) must have at least one bi-dimensionally measurable lesion
• For all men or women of childbearing potential (unless surgically sterile): use of adequate methods of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly

Exclusion Criteria:

• Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks before Cycle 1, Day 1
• Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1. Adverse events from any previous treatments must be resolved or stabilized prior to Cycle 1, Day 1, except for neuropathy
• Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
• Prior allogeneic stem cell transplant