A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma

NCT05645107 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: GC2202XEMBIFY® - CLL, MM, and NHL2022-502193-16-00
• Study Type: interventional
• Target: 386
• Locations: 8 countries
• Sites: 62

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; Multiple Myleoma; B-cell Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Annual Rate of Major Bacterial Infections per Year

  Up to Week 51

Secondary Outcomes (13)

• Time to First Onset of Major Bacterial Infection

  Up to Week 51

• Percentage of Participants who Experience Major Bacterial Infections

  Up to Week 51

• Rate of all Bacterial Infections Determined by the Investigator

  Up to Week 51

• Percentage of Participants who Experience Bacterial Infections

  Up to Week 51

• Time to First Onset of Non-Major Bacterial Infections

  Up to Week 51

Study Arms (2)

XEMBIFY + Standard Medical Treatment (SMT)

EXPERIMENTAL

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.

Drug: Xembify

Placebo + SMT

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Xembify DRUG

SC infusion pump

Also known as: Immune Globulin Subcutaneous (Human), 20% (IGSC 20%)

XEMBIFY + Standard Medical Treatment (SMT)

Placebo DRUG

SC infusion pump

Also known as: 0.9% Normal Saline

Placebo + SMT

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Grifols Therapeutics LLC: lead

Study Sites (62)

GC2202 Study Site 115

Huntington Park, California, 90255, United States

RECRUITING

GC2202 Study Site 103

St. Petersburg, Florida, 33701, United States

RECRUITING

GC2202 Study Site 111

Bethesda, Maryland, 20889, United States

RECRUITING

GC2202 Study Site 109

Greenville, North Carolina, 27843, United States

RECRUITING

GC2202 Decentralized Study Site 114

Morrisville, North Carolina, 27560, United States

RECRUITING

GC2202 Study Site 105

Canton, Ohio, 44718, United States

RECRUITING

GC2202 Study Site 110

Rockville, South Carolina, 29732, United States

WITHDRAWN

GC2202 Study Site 702

Banja Luka, 780000, Bosnia and Herzegovina

RECRUITING

GC2202 Study Site 703

Mostar, 88000, Bosnia and Herzegovina

RECRUITING

GC2202 Study Site 701

Sarajevo, 71000, Bosnia and Herzegovina

NOT YET RECRUITING

GC2202 Study Site 202

Burgas, 8000, Bulgaria

RECRUITING

GC2202 Study Site 203

Plovdiv, 4000, Bulgaria

RECRUITING

GC2202 Study Site 210

Plovdiv, 4003, Bulgaria

RECRUITING

GC2202 Study Site 205

Rousse, 7000, Bulgaria

RECRUITING

GC2202 Study Site 209

Sofia, 1142, Bulgaria

RECRUITING

GC2202 Study Site 201

Sofia, 1431, Bulgaria

RECRUITING

GC2202 Study Site 206

Sofia, 1606, Bulgaria

RECRUITING

GC2202 Study Site 207

Sofia, 1612, Bulgaria

RECRUITING

GC2202 Study Site 211

Sofia, 1618, Bulgaria

RECRUITING

GC2202 Study Site 212

Sofia, 1750, Bulgaria

RECRUITING

GC2202 Study Site 213

Sofia, 1756, Bulgaria

RECRUITING

GC2202 Study Site 204

Sofia, 1797, Bulgaria

RECRUITING

GC2202 Study Site 208

Sofia, 1797, Bulgaria

RECRUITING

GC2202 Study Site 214

Stara Zagora, 6000, Bulgaria

RECRUITING

GC2202 Study Site 801

Rijeka, 51000, Croatia

RECRUITING

GC2202 Study Site 802

Zagreb, 10000, Croatia

RECRUITING

GC2202 Study Site 305

Székesfehérvár, Fejér, 8000, Hungary

WITHDRAWN

GC2202 Study Site 301

Budapest, 1097, Hungary

RECRUITING

GC2202 Study Site 308

Budapest, 1122, Hungary

RECRUITING

GC2202 Study Site 306

Debrecen, 4032, Hungary

RECRUITING

GC2202 Study Site 304

Eger, 3300, Hungary

RECRUITING

GC2202 Study Site 302

Győr, 9024, Hungary

RECRUITING

GC2202 Study Site 307

Szeged, 6725, Hungary

RECRUITING

GC2202 Study Site 303

Szekszárd, 7110, Hungary

RECRUITING

GC2202 Study Site 402

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

RECRUITING

GC2202 Study Site 401

Krakow, Lesser Poland Voivodeship, 30 688, Poland

RECRUITING

GC2202 Study Site 401

Krakow, Lesser Poland Voivodeship, 31-501, Poland

RECRUITING

GC2202 Study Site 403

Legnica, Lower Silesian Voivodeship, 59-220, Poland

RECRUITING

GC2202 Study Site 406

Wałbrzych, Lower Silesian Voivodeship, 58 309, Poland

RECRUITING

GC2202 Study Site 406

Wałbrzych, Lower Silesian Voivodeship, 58-309, Poland

RECRUITING

GC2202 Study Site 405

Słupsk, Pomeranian Voivodeship, 76-200, Poland

RECRUITING

GC2202 Study Site 408

Bydgoszcz, 85-168, Poland

RECRUITING

GC2202 Study Site 410

Krakow, 31-826, Poland

NOT YET RECRUITING

GC2202 Study Site 409

Olsztyn, 10-228, Poland

RECRUITING

GC2202 Study Site 407

Torun, 87-100, Poland

NOT YET RECRUITING

GC2202 Study Site 511

Bucharest, Bucharest, 022328, Romania

RECRUITING

GC2202 Study Site 501

Bucharest, Bucharest, 20125, Romania

RECRUITING

GC2202 Study Site 503

Brasov, RO, 500052, Romania

RECRUITING

GC2202 Study Site 504

Bucharest, RO, 30171, Romania

RECRUITING

GC2202 Study Site 506

Cluj-Napoca, RO, 400015, Romania

RECRUITING

GC2202 Study Site 502

Timișoara, RO, 300041, Romania

RECRUITING

GC2202 Study Site 509

Bucharest, 022322, Romania

RECRUITING

GC2202 Study Site 508

Bucharest, 050098, Romania

RECRUITING

GC2202 Study Site 507

Constanța, 905900, Romania

RECRUITING

GC2202 Study Site 510

Iași, 700483, Romania

RECRUITING

GC2202 Study Site 602

Belgrade, 11000, Serbia

RECRUITING

GC2202 Study Site 604

Belgrade, 11000, Serbia

RECRUITING

GC2202 Study Site 605

Belgrade, 11080, Serbia

WITHDRAWN

GC2202 Study Site 607

Belgrade, 11080, Serbia

RECRUITING

GC2202 Study Site 603

Kamenitz, 21204, Serbia

RECRUITING

GC2202 Study Site 601

Kragujevac, 34000, Serbia

RECRUITING

GC2202 Study Site 606

Niš, 18000, Serbia

RECRUITING

MeSH Terms

Conditions

Agammaglobulinemia; Bacterial Infections; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin

Interventions

gamma-Globulins; Saline Solution

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Bacterial Infections and Mycoses; Infections; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Immunoproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Karen Pellath

CONTACT

+1 9194337967; karen.pellath@grifols.com

Marina Acosta Enslen

CONTACT

marina.acostaenslen@grifols.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: December 26, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BO (3); RO (10); PL (11); HU (8); SE (7); CR (2); BU (14); US (7)