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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | XmAb5574 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XmAb5574 | Biological | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the dose limiting toxicities | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John C Byrd, MD | Ohio State University, Columbus, Ohio | Principal Investigator |
| Farrukh Awan, MD | Georgia Health Sciences University, Augusta, Georgia | Principal Investigator |
| Ian W Flinn, MD, PhD | Sarah Cannon Research Institute, Nashville, Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Georgia | Augusta | Georgia | 30912 | United States | ||
| The Ohio State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25301708 | Derived | Woyach 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. |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000613469 | tafasitamab |
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| Columbus |
| Ohio |
| 43202 |
| United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |