HypogammaglobulinemiaPhase 3EXCELLNCT05645107
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
A Phase 3 study testing Xembify in people with Hypogammaglobulinemia and Bacterial Infections, run by Grifols Therapeutics LLC at 62 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypogammaglobulinemia, Bacterial Infections, B-cell Chronic Lymphocytic Leukemia
- What is being tested?
- Xembify
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 386 participants
- Where
- 62 sitesin 8 countries
- Study dates
- 26 Dec 2022to Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 18Show fewer
- 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).
Trial locations and contacts
62 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Marina Acosta Enslen contact
62 sites in 8 countries
Bulgaria14 sites, 14 recruiting
- Recruiting
GC2202 Study Site 202
Burgas, 8000
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 203
Plovdiv, 4000
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 210
Plovdiv, 4003
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 205
Rousse, 7000
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 209
Sofia, 1142
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 201
Sofia, 1431
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 206
Sofia, 1606
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 207
Sofia, 1612
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 211
Sofia, 1618
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 212
Sofia, 1750
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 213
Sofia, 1756
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 204
Sofia, 1797
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 208
Sofia, 1797
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 214
Stara Zagora, 6000
karen.pellath@grifols.com
Romania10 sites, 10 recruiting
- Recruiting
GC2202 Study Site 503
Brasov, RO, 500052
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 511
Bucharest, Bucharest, 022328
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 501
Bucharest, Bucharest, 20125
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 504
Bucharest, RO, 30171
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 509
Bucharest, 022322
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 508
Bucharest, 050098
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 506
Cluj-Napoca, RO, 400015
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 507
Constanța, 905900
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 510
Iași, 700483
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 502
Timișoara, RO, 300041
karen.pellath@grifols.com
United States9 sites, 8 recruiting
- Recruiting
GC2202 Study Site 111
Bethesda, Maryland, 20889
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 118
Bullhead City, Arizona, 86642
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 105
Canton, Ohio, 44718
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 109
Greenville, North Carolina, 27843
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 115
Huntington Park, California, 90255
karen.pellath@grifols.com
- Recruiting
GC2202 Decentralized Study Site 114
Morrisville, North Carolina, 27560
karen.pellath@grifols.com
- Withdrawn
GC2202 Study Site 110
Rockville, South Carolina, 29732
- Recruiting
GC2202 Study Site 103
St. Petersburg, Florida, 33701
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 117
Wilson, North Carolina, 27893
karen.pellath@grifols.com
Poland9 sites, 9 recruiting
- Recruiting
GC2202 Study Site 408
Bydgoszcz, 85-168
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 401
Krakow, Lesser Poland Voivodeship, 31-501
karen.pellath@grifols.com
- Not yet recruiting
GC2202 Study Site 410
Krakow, 31-826
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 403
Legnica, Lower Silesian Voivodeship, 59-220
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 409
Olsztyn, 10-228
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 405
Słupsk, Pomeranian Voivodeship, 76-200
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 402
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
karen.pellath@grifols.com
- Not yet recruiting
GC2202 Study Site 407
Torun, 87-100
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 406
Wałbrzych, Lower Silesian Voivodeship, 58 309
karen.pellath@grifols.com
Hungary8 sites, 7 recruiting
- Recruiting
GC2202 Study Site 301
Budapest, 1097
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 308
Budapest, 1122
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 306
Debrecen, 4032
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 304
Eger, 3300
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 302
Győr, 9024
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 307
Szeged, 6725
karen.pellath@grifols.com
- Withdrawn
GC2202 Study Site 305
Székesfehérvár, Fejér, 8000
- Recruiting
GC2202 Study Site 303
Szekszárd, 7110
karen.pellath@grifols.com
Serbia7 sites, 6 recruiting
- Recruiting
GC2202 Study Site 602
Belgrade, 11000
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 604
Belgrade, 11000
karen.pellath@grifols.com
- Withdrawn
GC2202 Study Site 605
Belgrade, 11080
- Recruiting
GC2202 Study Site 607
Belgrade, 11080
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 603
Kamenitz, 21204
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 601
Kragujevac, 34000
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 606
Niš, 18000
karen.pellath@grifols.com
Bosnia and Herzegovina3 sites, 3 recruiting
- Recruiting
GC2202 Study Site 702
Banja Luka, 780000
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 703
Mostar, 88000
karen.pellath@grifols.com
- Not yet recruiting
GC2202 Study Site 701
Sarajevo, 71000
karen.pellath@grifols.com
Croatia2 sites, 2 recruiting
- Recruiting
GC2202 Study Site 801
Rijeka, 51000
karen.pellath@grifols.com
- Recruiting
GC2202 Study Site 802
Zagreb, 10000
karen.pellath@grifols.com
About this study
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
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
- Being tested
- Xembify, Placebo
- Keywords
- XEMBIFY, CLL, SMT, Hypogammaglobulinemia (HGG), MM, NHL
- Medical subject headings
- Agammaglobulinemia, Bacterial Infections, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XembifyDrug
Also called Immune Globulin Subcutaneous (Human), 20% (IGSC 20%)
SC infusion pump
PlaceboDrug
Also called 0.9% Normal Saline
SC infusion pump
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual Rate of Major Bacterial Infections per Year
Measured: Up to Week 51
Secondary outcomes (13)
Time to First Onset of Major Bacterial Infection
Measured: Up to Week 51
Percentage of Participants who Experience Major Bacterial Infections
Measured: Up to Week 51
Rate of all Bacterial Infections Determined by the Investigator
Measured: Up to Week 51
Percentage of Participants who Experience Bacterial Infections
Measured: Up to Week 51
Time to First Onset of Non-Major Bacterial Infections
Measured: Up to Week 51
Number of Days on Which Participants Were on Antibiotics
Measured: Up to Week 51
Number of Hospitalizations due to any Infections
Measured: Up to Week 51
Duration of Hospitalizations due to any Infections
Measured: Up to Week 51
Number of Hospitalizations due to Major Bacterial Infections
Measured: Up to Week 51
Duration of Hospitalizations due to Major Bacterial Infections
Measured: Up to Week 51
Rate of all Infections as Determined by the Investigator
Measured: Up to Week 51
Number of Participants with Validated Infections
Measured: Up to Week 51
Time to First Onset of any Infection
Measured: Up to Week 51
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start26 Dec 2022
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogammaglobulinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645107
- Sponsor's protocol ID
- GC2202
- Other IDs
- XEMBIFY® - CLL, MM, and NHL, 2022-502193-16-00
- Acronym
- EXCELL
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05645107
- Acronym / sponsor ID
- EXCELL / GC2202
- Conditions
- Hypogammaglobulinemia, Bacterial Infections, B-cell Chronic Lymphocytic Leukemia, Multiple Myleoma, Non-Hodgkin Lymphoma
- Keywords
- XEMBIFY, CLL, SMT, Hypogammaglobulinemia (HGG), MM, NHL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XEMBIFY + Standard Medical Treatment (SMT) | Experimental | Drug: XembifyParticipants 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 + SMT | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants ≥18 years of age at screening visit
- Participants with documented and confirmed diagnosis of any of the below diseases:
- 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).
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XembifyAlso: Immune Globulin Subcutaneous (Human), 20% (IGSC 20%)SC infusion pump | Drug | XEMBIFY + Standard Medical Treatment (SMT) |
| PlaceboAlso: 0.9% Normal SalineSC infusion pump | Drug | Placebo + SMT |
Primary outcome
Annual Rate of Major Bacterial Infections per Year
Time frame: Up to Week 51
13 secondary outcomes
Time to First Onset of Major Bacterial Infection
Time frame: Up to Week 51
Percentage of Participants who Experience Major Bacterial Infections
Time frame: Up to Week 51
Rate of all Bacterial Infections Determined by the Investigator
Time frame: Up to Week 51
Percentage of Participants who Experience Bacterial Infections
Time frame: Up to Week 51
Time to First Onset of Non-Major Bacterial Infections
Time frame: Up to Week 51
Number of Days on Which Participants Were on Antibiotics
Time frame: Up to Week 51
Number of Hospitalizations due to any Infections
Time frame: Up to Week 51
Duration of Hospitalizations due to any Infections
Time frame: Up to Week 51
Number of Hospitalizations due to Major Bacterial Infections
Time frame: Up to Week 51
Duration of Hospitalizations due to Major Bacterial Infections
Time frame: Up to Week 51
Rate of all Infections as Determined by the Investigator
Time frame: Up to Week 51
Number of Participants with Validated Infections
Time frame: Up to Week 51
Time to First Onset of any Infection
Time frame: Up to Week 51
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Hypogammaglobulinemia
RecruitingObservational study
Immune Regulation in Patients With Common Variable Immunodeficiency and Related Inborn Errors of Immunity (IEI)
XLA, CVID
RecruitingPhase 3
Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections
Hypogammaglobulinemia, Autoimmune Conditions
Enrolling by invitationPhase 1/2
Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM
WHIM, Warts
RecruitingPhase 3
Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies
Secondary Immune Deficiency
RecruitingPhase 2
Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
Multiple Myeloma, Hypogammaglobulinemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marina Acosta Enslen contact
62 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xembify in people with Hypogammaglobulinemia and Bacterial Infections, run by Grifols Therapeutics LLC at 62 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Bulgaria, Romania, United States, Poland, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Pellath (+1 9194337967, karen.pellath@grifols.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual Rate of Major Bacterial Infections per Year (time frame: Up to Week 51). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.