Monthly IV Gamunex-C to reduce serious infections in people with low antibodies from CLL, MM, or NHL

An Open-label, Multi-Center, Single-arm Prospective Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex®-C Plus Standard Medical Treatment to Prevent Infections in Participants With Secondary Antibody Deficiency Associated With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma

This trial will try monthly IV Gamunex‑C for one year to see if people with low IgG from chronic lymphocytic leukemia, multiple myeloma, or non‑Hodgkin lymphoma get fewer serious infections.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Grifols Biologicals, LLC (Industry-sponsored)
• Locations: 5 sites (St. Petersburg, Florida and 4 other locations)
• Trial ID: NCT07582432 on ClinicalTrials.gov

What this trial studies

This Phase 3, open-label interventional trial gives all participants Gamunex‑C 500 mg/kg by IV once every 4 weeks for 13 doses over 48 weeks alongside their usual care to measure infection outcomes. The primary goal is to compare rates of serious infections in patients with secondary antibody deficiency related to B‑cell CLL, MM, or B‑cell NHL who have low IgG (<5 g/L) at screening. Key inclusion criteria specify disease stage (Rai intermediate/high for CLL, R‑ISS II/III for MM, or stage III/IV or relapsed/refractory B‑cell NHL) and exclude recent allogeneic transplant, recent Ig replacement therapy, or active infection at screening. The sponsor is Grifols Biologicals, LLC, and study visits are at a small set of U.S. clinical sites.

Who should consider this trial

Good fit: Ideal candidates are adults with B‑cell CLL (Rai intermediate/high), multiple myeloma (R‑ISS II/III), or B‑cell NHL (stage III/IV or relapsed/refractory) who have IgG levels below 5 g/L and do not have recent Ig replacement therapy or active infection.

Not a fit: Patients with normal IgG levels, those currently receiving Ig replacement therapy, recent allogeneic stem cell transplant within 6 months, or active infections are unlikely to be eligible and may not receive benefit from this protocol.

Why it matters

Potential benefit: If effective, monthly Gamunex‑C could reduce the number of serious infections, hospitalizations, and infection‑related complications in these immunocompromised patients.

How similar studies have performed: IV immunoglobulin replacement has previously reduced infection rates in patients with secondary antibody deficiency, so this approach builds on existing clinical experience rather than being entirely novel.

Eligibility criteria

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 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.

Exclusion Criteria:

* 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.
* Participants who have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral PI which have decreased IgA in addition to decreased IgG requiring IgG replacement).
* 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.
* Participants have participated in another clinical trial within 30 days prior to Screening Visit (NOTE: observational studies without investigative treatments \[non-interventional\] and interventional studies to treat CLL, MM, or NHL are permitted).
* Participants / caregivers are unwilling to comply with any aspect of the protocol for the duration of the study.
* In the opinion of the investigator, participants may have compliance problems with the protocol and the procedures of the protocol.

Where this trial is running

St. Petersburg, Florida and 4 other locations

• Study Site 102 — St. Petersburg, Florida, United States (Not_yet_recruiting)
• Study Site 101 — Fort Wayne, Indiana, United States (Recruiting)
• Study Site 105 — Westbrook, Maine, United States (Not_yet_recruiting)
• Study Site 104 — Columbus, Ohio, United States (Not_yet_recruiting)
• Study Site 103 — Tacoma, Washington, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Judith Wessels-Kranz

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