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hA20-humanized anti-CD20 antibody

Phase 1

Non-Hodgkin's Lymphoma | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 17, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment82

FDA Designations

No designations recorded

Clinical trial landscape

hA20-humanized anti-CD20 antibody · 1 trial · 1 indication

Phase 1 1
NCT00285428Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's LymphomaNon-Hodgkin's Lymphoma
COMPLETED82 Analytics
PHASE1COMPLETED
Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma
Non-Hodgkin's LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerance of different dose levels
12 weeks

Secondary Endpoints

Lack of immunogenicity
8 and 12 weeks
Pharmacodynamics
over 12 weeks
Pharmacokinetics
over 12 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose level 1EXPERIMENTAL120 mg/m2
Dose level 2EXPERIMENTAL200 mg/m2
Dose Level 3EXPERIMENTAL375 mg/m2
Dose level 1BEXPERIMENTAL80 mg/m2

Interventions

NameTypeDescription
hA20-humanized anti-CD20 antibodyDRUGonce weekly iv dosing for 4 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease

Countries:United States
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Frequently asked questions about hA20-humanized anti-CD20 antibody

What is hA20-humanized anti-CD20 antibody used for?

hA20-humanized anti-CD20 antibody is an investigational therapy being studied for the treatment of Non-Hodgkin's Lymphoma, specifically in patients with CD20+ disease. It is a humanized antibody designed to target CD20, a protein found on the surface of B-cells. The drug is currently in clinical development and has not been approved by regulatory authorities.

What does hA20-humanized anti-CD20 antibody target?

hA20-humanized anti-CD20 antibody targets the CD20 antigen, a cell surface marker expressed on B-cells. By binding to CD20, the antibody is intended to direct an immune response against CD20-positive cells, which are implicated in Non-Hodgkin's Lymphoma. This mechanism is being evaluated in clinical trials for its therapeutic potential.

Who makes hA20-humanized anti-CD20 antibody?

hA20-humanized anti-CD20 antibody is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is responsible for the clinical development and regulatory strategy for this investigational oncology asset.

What phase is hA20-humanized anti-CD20 antibody in?

hA20-humanized anti-CD20 antibody is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains under evaluation for safety and preliminary efficacy in Non-Hodgkin's Lymphoma.

What clinical trials is hA20-humanized anti-CD20 antibody in?

hA20-humanized anti-CD20 antibody has been studied in one completed Phase 1 clinical trial, identified by the National Clinical Trial number NCT00285428. The trial, titled 'Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma,' enrolled 82 participants in the United States. The study was controlled but not randomized or double-blinded.