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Gamunex-C, 10% Injectable

Phase 3

Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma | Small molecule | Oncology |Grifols, S.A.|Last Updated: May 12, 2026

Target and mechanism

ModalitySmall molecule

Also known as Gamunex-C, Gamunex-C, 10% Injectable Solution

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

Gamunex-C, 10% Injectable · 1 trial · 1 indication

Phase 3 1
NCT07582432A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin LymphomaChronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
RECRUITING49 Analytics
PHASE3RECRUITING
A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
NCT0758243249
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Study Endpoints

Primary Endpoints

serious bacterial infection (SBI) rate per-participant per year.
During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first

Secondary Endpoints

Time to first onset of SBI
During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first
Time to first onset of severe bacterial infection
During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Proportion of participants who experience at least one severe bacterial infection.
During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GAMUNEX®-C administered via IV Q4WEXPERIMENTAL -

Interventions

NameTypeDescription
Gamunex-C, 10% Injectable SolutionDRUGSterile solution
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Eligibility Criteria

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

Inclusion Criteria: Participants with documented and confirmed diagnosis of any of the diseases below: * B-cell CLL according to iwCLL criteria and Rai staging of intermediate (1 and 2) or high (3 and 4); or * MM according to the International Myeloma Working Group criteria (IMWG), R ISS stage II ...

Countries:United States
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Frequently asked questions about Gamunex-C, 10% Injectable

What is GAMUNEX-C used for?

GAMUNEX-C is an investigational immune globulin product being studied for use in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), chronic lymphocytic leukemia, multiple myeloma, non-Hodgkin lymphoma, primary immunodeficiency, and COVID-19. It is a monoclonal antibody product developed by Grifols, S.A. (NASDAQ: GRFS).

How does GAMUNEX-C work?

GAMUNEX-C is a monoclonal antibody product. It is a form of immune globulin that provides passive immunity by delivering antibodies to patients. The specific molecular target has not been disclosed in the available information.

Who makes GAMUNEX-C?

GAMUNEX-C is developed by Grifols, S.A., a biopharmaceutical company traded on NASDAQ under the ticker GRFS. The company is conducting clinical trials to evaluate the product's safety and efficacy across several indications.

What phase is GAMUNEX-C in?

GAMUNEX-C is in Phase 2 clinical development for COVID-19, with one completed Phase 2 trial. It is also being studied in Phase 3 trials for primary immunodeficiency, CIDP, and hematologic malignancies. It is investigational and not yet approved by the FDA.

What clinical trials is GAMUNEX-C in?

GAMUNEX-C has been studied in several trials. NCT04480424 is a completed Phase 2 trial in COVID-19. NCT04561115 is a completed Phase 3 trial in primary immunodeficiency. NCT07540221 is a recruiting Phase 3 trial in CIDP. NCT07582432 is a recruiting Phase 3 trial in chronic lymphocytic leukemia, multiple myeloma, or non-Hodgkin lymphoma.

Is GAMUNEX-C the same as Gamunex-C, 10% Injectable Solution?

Yes, GAMUNEX-C is also known as Gamunex-C, 10% Injectable Solution. The product is referred to by these alternative names in clinical trial documentation and regulatory filings.