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hA20-humanized anti-CD20 antibody

Phase 2

Non-Hodgkin's Lymphoma | Small molecule | Oncology |Gilead Sciences, Inc.|Trials Updated: Aug 18, 2021

hA20-humanized anti-CD20 antibody development status

Highest phase Phase 2 run by Takeda (NCT01390545)
Phase scored for GILDPhase 1
Registered trials 9 across 5 sponsors since Feb 2006

hA20-humanized anti-CD20 antibody target and mechanism

ModalitySmall molecule

Also known as veltuzumab, IMMU-106, hA20

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials3
Total Enrollment153

FDA Designations

No designations recorded

hA20-humanized anti-CD20 antibody clinical trials

hA20-humanized anti-CD20 antibody · 3 trials · 21 indications

Phase 1 3
NCT00546793Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLLNHL
COMPLETED32 Analytics
NCT00285428Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's LymphomaNon-Hodgkin's Lymphoma
COMPLETED82 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
Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma
Non-Hodgkin's LymphomaUnlock 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 and tolerance of different dose levels
12 weeks
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

Lack of immunogenicity
8 and 12 weeks
Pharmacodynamics
over 12 weeks
Pharmacokinetics
over 12 weeks
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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.
Dose level 1EXPERIMENTAL120 mg/m2
Dose level 2EXPERIMENTAL200 mg/m2
Dose Level 3EXPERIMENTAL375 mg/m2
Dose level 1BEXPERIMENTAL80 mg/m2

Interventions

NameTypeDescription
veltuzumabBIOLOGICALveltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.
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 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 hA20-humanized anti-CD20 antibody

What is hA20-humanized anti-CD20 antibody?

hA20 is a humanized anti-CD20 antibody being developed by Gilead Sciences, Inc. (ticker: GILD) for the treatment of CD20-positive non-Hodgkin's lymphoma. It is an investigational therapy that has been studied in a Phase 1 clinical trial. The drug targets the CD20 antigen found on B cells.

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

hA20 is being studied for use in patients with CD20-positive non-Hodgkin's lymphoma. The Phase 1 trial enrolled 82 patients aged 18 years and older in the United States. It is an investigational agent and has not been approved for commercial use.

What does hA20-humanized anti-CD20 antibody target?

hA20 targets the CD20 antigen, a protein found on the surface of B cells. By binding to CD20, the antibody is designed to act against CD20-positive B-cell lymphomas. The trial specifically enrolled patients with CD20+ non-Hodgkin's lymphoma, indicating the therapy is biomarker-selected for CD20 expression.

Who makes hA20-humanized anti-CD20 antibody?

hA20 is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program evaluating this humanized anti-CD20 antibody in non-Hodgkin's lymphoma.

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

hA20 is in Phase 1 clinical development. The single Phase 1 trial, NCT00285428, has been completed and enrolled 82 patients. The drug is investigational and has not been approved by the FDA for any indication.

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

hA20 has been evaluated in one completed Phase 1 trial, NCT00285428, titled "Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma." The trial enrolled 82 patients in the United States and included a controlled design. No active trials are currently listed for this agent.