A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma

NCT07582432 | Recruiting Phase 3 FDA Drug

• 1 other identifier: GC2502
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 5

Brief Summary

The main goal of this study is to show that people with certain immune problems (from Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma) get fewer serious infections when they receive Gamunex C through an IV once every 4 weeks, along with their usual medical care, for one year. All participants will receive Gamunex-C 500 mg/kg once every 4 weeks (total 13 doses) starting Day 1 (Week 1) through Week 48 (end of Treatment Phase).

Conditions

Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma

Keywords

Phase 3; Clinical trial; Secondary Antibody Deficiency Associated with Chronic Lymphocytic Leukemia; Multiple Myeloma; Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• 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.

• The rate of severe bacterial infections 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.

• The rate of all bacterial infections 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.

Study Arms (1)

GAMUNEX®-C administered via IV Q4W

EXPERIMENTAL

Drug: Gamunex-C, 10% Injectable Solution

Interventions

Gamunex-C, 10% Injectable Solution DRUG

Sterile solution

GAMUNEX®-C administered via IV Q4W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or, III; or
• Histologically confirmed diagnosis of B-cell NHL, Stage III or above (IV, Progressive/refractory, or recurrent/relapsed stage) according to the Lugano Classification.
• Participants with HGG with IgG levels \<5g/L at screening.

You may not qualify if:

• Participants with documented history of allogeneic hematopoietic stem cell transplant within 6 months before Screening Visit.
• Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement treatment (i.e., prior immune globulin replacement therapy) within 6 months before the Screening Visit.
• Participants with any active infections at the time of Screening Visit. Participants with active secondary malignancies.
• Participants with known PID.
• Participants with a life expectancy less than 1.5 years.
• Participants with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the participant at undue medical risk.
• Participants who have had known serious treatment related adverse events to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product.
• Females of childbearing potential who are pregnant, have a positive pregnancy test at Screening Visit (serum human chorionic gonadotropin-based assay), are breastfeeding, or unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence\*) throughout the study. Note: \*True abstinence: When this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.)
• Participants with severe known kidney disease (as defined by estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration \[eGFR CKD-EPI\] \<30 mL/min/1.73 m2) as determined by the Principal Investigator.
• Participants that have liver enzyme levels (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyl transferase \[GGT\], or lactate dehydrogenase \[LDH\]) greater than 3 times the upper limit of normal at the Screening Visit as defined by the testing laboratory.
• Participants who have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of thromboembolic events \[e.g., DVT, PE, ischemic stroke (transient ischemic attack, and any ischemic cerebrovascular accident), myocardial infarction (including unstable angina and ischemic heart disease diagnosed in the last 6 months), retinal artery occlusion, mesenteric ischemia, and peripheral arterial disease (Fontaine III and IV)\]\*.(Fontaine I: asymptomatic. IIa: mild claudication. IIb: moderate to severe claudication. III: ischemia with rest pain. IV: ulceration or gangrene).
• Participants who currently have a known hyperviscosity syndrome or hypercoagulable states.
• Participants who have clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.
• Participants with non-controlled arterial hypertension (i.e., SBP \> 160 mmHg and/or DBP \> 100 mmHg), and/or HR \>100 bpm.
• Participants have known substance or prescription drug abuse within 12 months before the Screening Visit.

Sponsors & Collaborators

• Grifols Biologicals, LLC: lead

Study Sites (5)

Study Site 102

St. Petersburg, Florida, 33709, United States

NOT YET RECRUITING

Study Site 101

Fort Wayne, Indiana, 46894, United States

RECRUITING

Study Site 105

Westbrook, Maine, 04092, United States

NOT YET RECRUITING

Study Site 104

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Study Site 103

Tacoma, Washington, 98405, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Multiple Myeloma; Lymphoma, Non-Hodgkin

Interventions

Hizentra

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoma

Central Study Contacts

Judith Wessels-Kranz

CONTACT

+49 6103 801-6395,; judith.wesselskranz@external.grifols.com,

Marina Acosta Enslen

CONTACT

+1 (919) 813 9725; marina.acostaenslen@grifols.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 12, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (5)