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veltuzumab

Phase 1

NHL | Monoclonal antibody | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 18, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

veltuzumab · 2 trials · 21 indications

Phase 1 2
NCT00546793Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLLNHL
COMPLETED32 Analytics
NCT00596804Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's LymphomaNon-Hodgkin's Lymphoma
COMPLETED39 Analytics
PHASE1COMPLETED
Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL
NHLUnlock trial analytics
PHASE1COMPLETED
Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma
Non-Hodgkin's LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety/tolerability
over 2 years after treatment

safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.

Safety of hA20 with this administration schedule and dosing
first 12 weeks, then over 2 years
tolerance of hA20 with this administration schedule and dosing
first 12 weeks
immunogenicity of hA20 with this administration schedule and dosing
first 12 weeks, as needed over 2 years

Secondary Endpoints

Pharmacodynamics of hA20
first 12 weeks, then up to 2 years
pharmacokinetics hA20
first 12 weeks, then up to 2 years
assess efficacy
4 and 12 weeks, then every 3 months for 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
veltuzumabEXPERIMENTALveltuzumab is a humanized CD20 antibody administered subcutaneously in this study.

Interventions

NameTypeDescription
veltuzumabBIOLOGICALveltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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:...

Countries:United StatesFranceUnited Kingdom
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Frequently asked questions about veltuzumab

What is veltuzumab used for?

Veltuzumab is an investigational monoclonal antibody being studied for the treatment of Non-Hodgkin's Lymphoma (NHL). It is a CD20-targeted therapy developed by Gilead Sciences, Inc. (GILD). As of the available data, veltuzumab is in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does veltuzumab target?

Veltuzumab targets the CD20 antigen, which is expressed on B-cells. By binding to CD20, the antibody is designed to direct an immune response against malignant B-cells in conditions like Non-Hodgkin's Lymphoma. This mechanism is being evaluated in early-phase clinical trials to assess its safety and potential efficacy.

Who makes veltuzumab?

Veltuzumab is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The drug is an investigational monoclonal antibody in Phase 1 clinical development for Non-Hodgkin's Lymphoma, and it has not yet received regulatory approval.

What phase is veltuzumab in?

Veltuzumab is in Phase 1 clinical development. It is an investigational drug for Non-Hodgkin's Lymphoma and has not been approved by the FDA or other regulatory bodies. The available clinical data includes completed Phase 1 trials, and the drug remains under investigation for its safety and efficacy.

What clinical trials is veltuzumab in?

Veltuzumab has been studied in two completed Phase 1 clinical trials. NCT00546793 evaluated subcutaneous administration in patients with NHL and CLL, enrolling 32 participants in the United States. NCT00596804 assessed different doses in CD20+ Non-Hodgkin's Lymphoma, enrolling 39 participants in France and the United Kingdom.

Is veltuzumab the same as hA20?

Yes, veltuzumab is also known as hA20. In clinical trials, the drug is referred to by both names, such as in NCT00546793, which is titled 'Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL.' This alternative name is used interchangeably in research contexts.