Clinical trial · Interventional
Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
A Phase 1 Study of XmAb®5574 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XmAb5574 | Biological | Tafasitamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- XmAb5574
- interventionNames
- Biological: XmAb5574
Primary outcomes (1)
- measure
- To determine the dose limiting toxicities
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWoyach JA, Awan F, Flinn IW, Berdeja JG, Wiley E, Mansoor S, Huang Y, Lozanski G, Foster PA, Byrd JC. A phase 1 trial of the Fc-engineered CD19 antibody XmAb5574 (MOR00208) demonstrates safety and preliminary efficacy in relapsed CLL. Blood. 2014 Dec 4;124(24):3553-60. doi: 10.1182/blood-2014-08-593269. Epub 2014 Oct 9. PMID 25301708