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New hope for blood cancer patients: drug aims to slash infection risk

NCT ID NCT05645107

Disease control Sponsor: Grifols Therapeutics LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study tests whether a medicine called XEMBIFY, given every two weeks alongside standard care, can reduce serious bacterial infections in adults with certain blood cancers (chronic lymphocytic leukemia, multiple myeloma, or non-Hodgkin lymphoma) who also have low antibody levels. About 386 participants will receive either XEMBIFY or a placebo for one year. The goal is to see if the drug helps prevent infections that can be dangerous for these patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 386 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

agammaglobulinemia B-cell chronic lymphocytic leukemia non-Hodgkin lymphoma plasma cell myeloma syndromic agammaglobulinemia bacterial infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell chronic lymphocytic leukemia Bacterial infections Hypogammaglobulinemia Multiple myleoma Non-Hodgkin lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    59 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GC2202 Decentralized Study Site 114

    RECRUITING

    Morrisville, North Carolina, 27560, United States

  • GC2202 Study Site 103

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • GC2202 Study Site 105

    RECRUITING

    Canton, Ohio, 44718, United States

  • GC2202 Study Site 109

    RECRUITING

    Greenville, North Carolina, 27843, United States

  • GC2202 Study Site 110

    WITHDRAWN

    Rockville, South Carolina, 29732, United States

  • GC2202 Study Site 111

    RECRUITING

    Bethesda, Maryland, 20889, United States

  • GC2202 Study Site 115

    RECRUITING

    Huntington Park, California, 90255, United States

  • GC2202 Study Site 201

    RECRUITING

    Sofia, 1431, Bulgaria

  • GC2202 Study Site 202

    RECRUITING

    Burgas, 8000, Bulgaria

  • GC2202 Study Site 203

    RECRUITING

    Plovdiv, 4000, Bulgaria

  • GC2202 Study Site 204

    RECRUITING

    Sofia, 1797, Bulgaria

  • GC2202 Study Site 205

    RECRUITING

    Rousse, 7000, Bulgaria

  • GC2202 Study Site 206

    RECRUITING

    Sofia, 1606, Bulgaria

  • GC2202 Study Site 207

    RECRUITING

    Sofia, 1612, Bulgaria

  • GC2202 Study Site 208

    RECRUITING

    Sofia, 1797, Bulgaria

  • GC2202 Study Site 209

    RECRUITING

    Sofia, 1142, Bulgaria

  • GC2202 Study Site 210

    RECRUITING

    Plovdiv, 4003, Bulgaria

  • GC2202 Study Site 211

    RECRUITING

    Sofia, 1618, Bulgaria

  • GC2202 Study Site 212

    RECRUITING

    Sofia, 1750, Bulgaria

  • GC2202 Study Site 213

    RECRUITING

    Sofia, 1756, Bulgaria

  • GC2202 Study Site 214

    RECRUITING

    Stara Zagora, 6000, Bulgaria

  • GC2202 Study Site 301

    RECRUITING

    Budapest, 1097, Hungary

  • GC2202 Study Site 302

    RECRUITING

    Győr, 9024, Hungary

  • GC2202 Study Site 303

    RECRUITING

    Szekszárd, 7110, Hungary

  • GC2202 Study Site 304

    RECRUITING

    Eger, 3300, Hungary

  • GC2202 Study Site 305

    WITHDRAWN

    Székesfehérvár, Fejér, 8000, Hungary

  • GC2202 Study Site 306

    RECRUITING

    Debrecen, 4032, Hungary

  • GC2202 Study Site 307

    RECRUITING

    Szeged, 6725, Hungary

  • GC2202 Study Site 308

    RECRUITING

    Budapest, 1122, Hungary

  • GC2202 Study Site 401

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30 688, Poland

  • GC2202 Study Site 401

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 31-501, Poland

  • GC2202 Study Site 402

    RECRUITING

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

  • GC2202 Study Site 403

    RECRUITING

    Legnica, Lower Silesian Voivodeship, 59-220, Poland

  • GC2202 Study Site 405

    RECRUITING

    Słupsk, Pomeranian Voivodeship, 76-200, Poland

  • GC2202 Study Site 406

    RECRUITING

    Wałbrzych, Lower Silesian Voivodeship, 58 309, Poland

  • GC2202 Study Site 406

    RECRUITING

    Wałbrzych, Lower Silesian Voivodeship, 58-309, Poland

  • GC2202 Study Site 407

    NOT_YET_RECRUITING

    Torun, 87-100, Poland

  • GC2202 Study Site 408

    RECRUITING

    Bydgoszcz, 85-168, Poland

  • GC2202 Study Site 409

    RECRUITING

    Olsztyn, 10-228, Poland

  • GC2202 Study Site 410

    NOT_YET_RECRUITING

    Krakow, 31-826, Poland

  • GC2202 Study Site 501

    RECRUITING

    Bucharest, Bucharest, 20125, Romania

  • GC2202 Study Site 502

    RECRUITING

    Timișoara, RO, 300041, Romania

  • GC2202 Study Site 503

    RECRUITING

    Brasov, RO, 500052, Romania

  • GC2202 Study Site 504

    RECRUITING

    Bucharest, RO, 30171, Romania

  • GC2202 Study Site 506

    RECRUITING

    Cluj-Napoca, RO, 400015, Romania

  • GC2202 Study Site 507

    RECRUITING

    Constanța, 905900, Romania

  • GC2202 Study Site 508

    RECRUITING

    Bucharest, 050098, Romania

  • GC2202 Study Site 509

    RECRUITING

    Bucharest, 022322, Romania

  • GC2202 Study Site 510

    RECRUITING

    Iași, 700483, Romania

  • GC2202 Study Site 511

    RECRUITING

    Bucharest, Bucharest, 022328, Romania

  • GC2202 Study Site 601

    RECRUITING

    Kragujevac, 34000, Serbia

  • GC2202 Study Site 602

    RECRUITING

    Belgrade, 11000, Serbia

  • GC2202 Study Site 603

    RECRUITING

    Kamenitz, 21204, Serbia

  • GC2202 Study Site 604

    RECRUITING

    Belgrade, 11000, Serbia

  • GC2202 Study Site 605

    WITHDRAWN

    Belgrade, 11080, Serbia

  • GC2202 Study Site 606

    RECRUITING

    Niš, 18000, Serbia

  • GC2202 Study Site 607

    RECRUITING

    Belgrade, 11080, Serbia

  • GC2202 Study Site 701

    NOT_YET_RECRUITING

    Sarajevo, 71000, Bosnia and Herzegovina

  • GC2202 Study Site 702

    RECRUITING

    Banja Luka, 780000, Bosnia and Herzegovina

  • GC2202 Study Site 703

    RECRUITING

    Mostar, 88000, Bosnia and Herzegovina

  • GC2202 Study Site 801

    RECRUITING

    Rijeka, 51000, Croatia

  • GC2202 Study Site 802

    RECRUITING

    Zagreb, 10000, Croatia

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