Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Conditions
Keywords
CLL, SLL, CD19
Brief summary
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.
Interventions
BIOLOGICALXmAb5574
Intravenous infusion of XmAb5574 administered weekly during two 28-day cycles with an additional dose being administered during the first week of Cycle 1. (Cycle 1 on Days 1, 4, 8, 15, 22; Cycle 2 on Days 1, 8, 15, 22)
Sponsors
Xencor, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the dose limiting toxicities | 28 days |
Countries
United States
Outcome results
None listed