Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

Xencor

Status and phase

Completed

Phase 1

Conditions

Small Lymphocytic Lymphoma

Chronic Lymphocytic Leukemia

Treatments

Biological: XmAb5574

Study type

Interventional

Funder types

Industry

Identifiers

NCT01161511

XmAb5574-01

Details and patient eligibility

About

This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574. The study was conducted to identify the maximum tolerated dose (MTD) and/or recommended dose(s) (RD) for further study, to characterize safety and tolerability, to characterize PK, PD and immunogenicity, and to evaluate preliminary antitumor activity of XmAb5574 in patients with relapsed or refractory CLL/SLL.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

relapsed or refractory CLL/SLL
at least 18 years of age
able to receive outpatient treatment and follow-up at the treating institution
completed all CLL therapies > 4 weeks prior to first study dose

Exclusion criteria

previously treated with an anti-CD19 antibody therapy
undergone prior allogeneic stem cell transplantation within 6 months or having active graft versus host disease
active Richter's syndrome
designated Class III or IV by the New York Heart Association (NYHA) criteria
history of myocardial infarction or stroke within the last 6 months
active viral, bacterial, or systemic fungal infection requiring treatment
HIV or Hepatitis C positive
Hepatitis B infection