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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 386 (estimated) |
| Sponsor | Grifols Therapeutics LLC Industry-sponsored |
| Locations | 62 sites (Bullhead City, Arizona and 61 other locations) |
| Status | Recruiting |
| Started | December 26, 2022 |
| Main results expected | August 2029 |
| Study ends | August 2029 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT05645107 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
- Study coordinator: Karen Pellath
- Email: karen.pellath@grifols.com
- Phone: +1 9194337967
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
New ways to diagnose lymphoma and multicentric Castleman disease in people living with HIV
This study tests a quick, point-of-care nucleic acid test to help diagnose lymphoma and multicentric Castleman disease in people living with HIV in sub-Saharan Africa.
-
Intrathecal Cytarabine and Hydrocortisone to Treat ICANS in NHL Patients Receiving CAR-T
This trial tests whether giving cytarabine and hydrocortisone into the spine early after CAR-T therapy can reduce brain-related side effects in adults with non-Hodgkin lymphoma.
-
Non-Hodgkin Lymphoma Sample Collection for MRD Testing
This study tests a blood-based and tissue-based approach to see if a molecular residual disease test can detect lingering cancer in adults with aggressive NHL who are starting standard therapy.
-
XNW5004 with CHOP/CHOEP in Untreated Peripheral T-Cell Lymphoma
This study tests XNW5004 together with CHOP or CHOEP in adults with newly diagnosed peripheral T-cell lymphoma to see if the combination is safe and active.
-
CTX-187 first-in-human test in healthy people and people with chronic bronchiectasis and Pseudomonas infection
This study tests CTX-187 to see if it is safe and tolerable when given as IV infusions to healthy adults and adults with chronic bronchiectasis and Pseudomonas aeruginosa infection.
-
Toxin exposure and immune factors in B-cell non-Hodgkin lymphoma
This study tests how toxin exposure, genetics, and immune issues relate to B-cell non-Hodgkin lymphoma in active-duty service members and other Military Health System beneficiaries.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.