Clinical trial Recruiting at 56 sites Phase 3 Interventional Ages 18 and up

Evaluating XEMBIFY® with standard treatment to prevent infections in patients with certain blood cancers

Official title: A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma

Run by Grifols Therapeutics LLC · NCT05645107 · Data updated 2026-11-12

This study is testing if adding XEMBIFY® to standard treatment can help prevent serious infections in adults with certain blood cancers.

More Non-Hodgkin Lymphoma trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment386 (estimated)
SponsorGrifols Therapeutics LLC
Industry-sponsored
Locations62 sites (Bullhead City, Arizona and 61 other locations)
StatusRecruiting
StartedDecember 26, 2022
Main results expectedAugust 2029
Study endsAugust 2029
Registry record updatedSeptember 30, 2026
Trial IDNCT05645107 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with a confirmed diagnosis of B-cell CLL, MM, or NHL, who also have low IgG levels and a history of severe or recurrent infections.

Probably not a fit

Patients without a documented history of severe bacterial infections or those with IgG levels above 5 g/L may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy and safety of XEMBIFY® combined with Standard Medical Treatment (SMT) in reducing major bacterial infections in adults with hypogammaglobulinemia (HGG) associated with B-cell Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), and Non-Hodgkin Lymphoma (NHL). Participants will receive biweekly doses of XEMBIFY® or a placebo over a one-year period. The primary outcome will measure the rate of major bacterial infections per participant per year, comparing the treatment group to the placebo group. This Phase 3 interventional trial is designed to provide insights into the potential benefits of XEMBIFY® in this patient population.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of severe bacterial infections in patients with specific blood cancers and hypogammaglobulinemia.

How similar studies have gone: Previous studies have shown promising results with similar treatments in reducing infection rates in patients with hypogammaglobulinemia, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Where it's running

  • GC2202 Study Site 118
    Bullhead City, Arizona, United States
    Recruiting
  • GC2202 Study Site 115
    Huntington Park, California, United States
    Recruiting
  • GC2202 Study Site 103
    St. Petersburg, Florida, United States
    Recruiting
  • GC2202 Study Site 111
    Bethesda, Maryland, United States
    Recruiting
  • GC2202 Study Site 109
    Greenville, North Carolina, United States
    Recruiting
  • GC2202 Decentralized Study Site 114
    Morrisville, North Carolina, United States
    Recruiting
Show 44 more locations
  • GC2202 Study Site 117
    Wilson, North Carolina, United States
    Recruiting
  • GC2202 Study Site 105
    Canton, Ohio, United States
    Recruiting
  • GC2202 Study Site 702
    Banja Luka, Bosnia and Herzegovina
    Recruiting
  • GC2202 Study Site 703
    Mostar, Bosnia and Herzegovina
    Recruiting
  • GC2202 Study Site 202
    Burgas, Bulgaria
    Recruiting
  • GC2202 Study Site 203
    Plovdiv, Bulgaria
    Recruiting
  • GC2202 Study Site 210
    Plovdiv, Bulgaria
    Recruiting
  • GC2202 Study Site 205
    Rousse, Bulgaria
    Recruiting
  • GC2202 Study Site 209
    Sofia, Bulgaria
    Recruiting
  • GC2202 Study Site 201
    Sofia, Bulgaria
    Recruiting
  • GC2202 Study Site 206
    Sofia, Bulgaria
    Recruiting
  • GC2202 Study Site 207
    Sofia, Bulgaria
    Recruiting
  • GC2202 Study Site 211
    Sofia, Bulgaria
    Recruiting
  • GC2202 Study Site 212
    Sofia, Bulgaria
    Recruiting
  • GC2202 Study Site 213
    Sofia, Bulgaria
    Recruiting
  • GC2202 Study Site 204
    Sofia, Bulgaria
    Recruiting
  • GC2202 Study Site 208
    Sofia, Bulgaria
    Recruiting
  • GC2202 Study Site 214
    Stara Zagora, Bulgaria
    Recruiting
  • GC2202 Study Site 801
    Rijeka, Croatia
    Recruiting
  • GC2202 Study Site 802
    Zagreb, Croatia
    Recruiting
  • GC2202 Study Site 301
    Budapest, Hungary
    Recruiting
  • GC2202 Study Site 308
    Budapest, Hungary
    Recruiting
  • GC2202 Study Site 306
    Debrecen, Hungary
    Recruiting
  • GC2202 Study Site 304
    Eger, Hungary
    Recruiting
  • GC2202 Study Site 302
    Győr, Hungary
    Recruiting
  • GC2202 Study Site 307
    Szeged, Hungary
    Recruiting
  • GC2202 Study Site 303
    Szekszárd, Hungary
    Recruiting
  • GC2202 Study Site 402
    Torun, Kuyavian-Pomeranian Voivodeship, Poland
    Recruiting
  • GC2202 Study Site 401
    Krakow, Lesser Poland Voivodeship, Poland
    Recruiting
  • GC2202 Study Site 403
    Legnica, Lower Silesian Voivodeship, Poland
    Recruiting
  • GC2202 Study Site 406
    Wałbrzych, Lower Silesian Voivodeship, Poland
    Recruiting
  • GC2202 Study Site 405
    Słupsk, Pomeranian Voivodeship, Poland
    Recruiting
  • GC2202 Study Site 408
    Bydgoszcz, Poland
    Recruiting
  • GC2202 Study Site 409
    Olsztyn, Poland
    Recruiting
  • GC2202 Study Site 511
    Bucharest, Bucharest, Romania
    Recruiting
  • GC2202 Study Site 501
    Bucharest, Bucharest, Romania
    Recruiting
  • GC2202 Study Site 503
    Brasov, Ro, Romania
    Recruiting
  • GC2202 Study Site 504
    Bucharest, Ro, Romania
    Recruiting
  • GC2202 Study Site 506
    Cluj-Napoca, Ro, Romania
    Recruiting
  • GC2202 Study Site 502
    Timișoara, Ro, Romania
    Recruiting
  • GC2202 Study Site 509
    Bucharest, Romania
    Recruiting
  • GC2202 Study Site 508
    Bucharest, Romania
    Recruiting
  • GC2202 Study Site 507
    Constanța, Romania
    Recruiting
  • GC2202 Study Site 510
    Iași, Romania
    Recruiting

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.