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Also known as hA20, humanized anti-CD20, IMMU-106, hA20-humanized anti-CD20 antibody, humanized CD20, epratuzumab-tetraxetan, 90Y-hLL2, IMMU-102
veltuzumab · 4 trials · 23 indications
safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.
| Arm | Type | Description |
|---|---|---|
| veltuzumab | EXPERIMENTAL | veltuzumab is a humanized CD20 antibody administered subcutaneously in this study. |
| Dose level 1 | EXPERIMENTAL | 120 mg/m2 |
| Dose level 2 | EXPERIMENTAL | 200 mg/m2 |
| Dose Level 3 | EXPERIMENTAL | 375 mg/m2 |
| Dose level 1B | EXPERIMENTAL | 80 mg/m2 |
| multi | EXPERIMENTAL | escalating in increments of 2.5 mCi/m2 |
| Name | Type | Description |
|---|---|---|
| veltuzumab | BIOLOGICAL | veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks. |
| hA20-humanized anti-CD20 antibody | DRUG | once weekly iv dosing for 4 weeks |
| 90Y-hLL2 | BIOLOGICAL | weekly dosing for either 2 or 3 weeks |
Inclusion Criteria: * Histologically confirmed diagnosis of CD20 positive chronic lymphocytic leukemia (CLL) * Either previously untreated or relapsed * Measurable disease (at least one lesion \> 1.5 cm for NHL, or ALC \> 5,000 for CLL) see full protocol for additional criteria Exclusion Criteria:...
Veltuzumab is an investigational monoclonal antibody developed by Gilead Sciences, Inc. (ticker GILD) for B-cell malignancies. It has been studied in Non-Hodgkin's Lymphoma and chronic lymphocytic leukemia. It is a Phase 1 agent and is not approved for commercial use.
Veltuzumab has been studied in Non-Hodgkin's Lymphoma, including follicular, diffuse, small lymphocytic, and intermediate-grade subtypes, as well as chronic lymphocytic leukemia. Trials enrolled adults aged 18 and older in the United States, France, and the United Kingdom. It remains investigational and is not approved for treating NHL.
Veltuzumab targets MS4A1, also known as CD20, a B-cell surface antigen. It is a monoclonal antibody binding agent directed at CD20-positive cells, which is why its clinical studies selected patients with CD20+ Non-Hodgkin's Lymphoma. Targeting CD20 is the basis for its investigation in B-cell malignancies.
Veltuzumab is developed by Gilead Sciences, Inc., which trades under the ticker GILD. The company is the sponsor associated with the clinical development of this monoclonal antibody in oncology.
Veltuzumab is in Phase 1 clinical development. It is an investigational monoclonal antibody and is not FDA approved. Its completed studies were early-stage trials evaluating safety and dosing in patients with CD20+ Non-Hodgkin's Lymphoma and related B-cell conditions.
Veltuzumab has been evaluated in completed Phase 1 studies, including NCT00596804, which tested different doses in CD20+ Non-Hodgkin's Lymphoma across France and the United Kingdom with 39 participants, and NCT00546793, which studied subcutaneous administration in NHL and CLL in the United States with 32 participants.