Recruiting
Phase 3

XEMBIFY

Sponsor:

Grifols Therapeutics LLC

Code:

NCT05645107

Conditions

Hypogammaglobulinemia

Bacterial Infections

B-cell Chronic Lymphocytic Leukemia

Multiple Myleoma

Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Xembify

Placebo

Study Details

Brief summary:

The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.

Conditions

Hypogammaglobulinemia

Bacterial Infections

B-cell Chronic Lymphocytic Leukemia

Multiple Myleoma

Non-Hodgkin Lymphoma

Study ID

NCT05645107

Start date

Dec 26, 2022

Status verified date

Jul, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants ≥18 years of age at screening visit
  • Participants with documented and confirmed diagnosis of any of the below diseases:

  • B-cell CLL according to International Workshop on CLL (iwCLL) criteria and RAI staging of intermediate (1 and 2) or high (3 and 4)
  • 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 less than 5 g/L. (Note: For MM subjects, the IgG level is adjusted by subtracting the M-protein \[Mspike\] to reflect the true polyclonal IgG concentration.)
  • Participants with documented history of at least one severe bacterial infection (bacterial or viral) or recurrent bacterial/viral infections (that is., ≥ 3 infections) within 12 months before the screening visit. Severe bacterial/viral infections ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events \[CTCAE\] Grades).

Exclusion Criteria:

  • Participants with documented history of hematopoietic stem cell transplant (allogenic transplant in the previous 24 months, and autologous transplant in the previous 3 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 active infections at time of screening visit. Specific supportive anti-infective prophylactic defined in the CLL National Comprehensive Cancer Network (NCCN) or iwCLL guidelines and/or local/international guidelines for the CLL, and defined in local/international guidelines for MM and NHL are allowed, or recommended in the updated labelling of specific active target disease medicines used during the participation in the trial is also allowed.
  • Participants with active second malignancies.
  • Participants with known primary immunodeficiency (PI).
  • 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 subject at undue medical risk.
  • Participants have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product.
  • Participants have a history of blistering skin disease, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study based upon the Investigator's discretion.
  • Participants 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 primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement).
  • Participants with severe known kidney disease \[as defined by estimated glomerular filtration rate \[eGFR\] less than (\<) 30 milliliter (mL)/min/1.73 square meter (m2)\] as determined by the Principal Investigator.
  • Participants that have liver enzyme levels (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gammaglutamyl transferase \[GGT\], or lactate dehydrogenase \[LDH\]) greater than 3 times the upper limit of normal (ULN) at the Screening Visit as defined by the testing laboratory.
  • Participants have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (example, myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis.
  • Participants currently have a known hyperviscosity syndrome or hypercoagulable states.
  • Participants have a known previous infection or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.
  • Participants with non-controlled arterial hypertension (systolic blood pressure \[SBP\] greater than 140 millimeters of mercury (mmHg) and/or diastolic blood pressure \[DBP\] greater than 90 mmHg), and/or a heart rate (HR) greater than100 bpm.
  • Participants with 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 (observational studies without investigative treatments \[non-interventional\] are permitted).

Study Design

Enrollment

386 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: XEMBIFY + Standard Medical Treatment (SMT)

Participants will receive a loading dose of 150 milligrams per kilograms per day (mg/kg/day) (Week 1, Days 1 to 5) subcutaneously (SC) for 5 consecutive daily doses followed by biweekly infusions of 300 mg/kg/2-week starting Week 3 (Day 15) through Week 51 (end of Treatment Phase).

The SMT will include the active treatments and the other supportive treatments that the participants will need during their participation.

placebo comparator: Placebo + SMT

Participants will receive sterile 0.9 percent Sodium Chloride Injection (commercially available in the corresponding country) starting at Week 1 (Days 1 to 5) SC for 5 consecutive daily doses followed by biweekly infusions starting at Week 3 (Day 15) through Week 51.

The SMT will include the active treatments and the other supportive treatments that the participants will need during their participation.

Interventions

Xembify

SC infusion pump

Placebo

SC infusion pump

Primary outcome measure

  • Annual Rate of Major Bacterial Infections per Year [ Time Frame: Up to Week 51 ]

Central Contacts and Locations

Central contacts

Karen Pellath

+1 9194337967karen.pellath@grifols.com

Marina Acosta Enslen

marina.acostaenslen@grifols.com

Locations

GC2202 Study Site 115

Recruiting

Huntington Park, California, United States, 90255

Contacts

SM-GC2202_Xembify_Study@grifols.com

GC2202 Study Site 103

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

SM-GC2202_Xembify_Study@grifols.com

GC2202 Study Site 111

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

SM-GC2202_Xembify_Study@grifols.com

GC2202 Study Site 109

Recruiting

Greenville, North Carolina, United States, 27843

Contacts

SM-GC2202_Xembify_Study@grifols.com

GC2202 Decentralized Study Site 114

Recruiting

Morrisville, North Carolina, United States, 27560

Contacts

SM-GC2202_Xembify_Study@grifols.com

GC2202 Study Site 105

Recruiting

Canton, Ohio, United States, 44718

Contacts

SM-GC2202_Xembify_Study@grifols.com

More Information

Sponsor

Grifols Therapeutics LLC

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • XEMBIFY
  • CLL
  • SMT
  • Hypogammaglobulinemia (HGG)
  • MM
  • NHL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Grifols Therapeutics LLC on 2026-07-29.