OncoMatch/Clinical Trials/NCT05645107
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
Is NCT05645107 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Xembify for hypogammaglobulinemia.
Treatment: Xembify — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Disease stage
Required: Stage RAI 1, RAI 2, RAI 3, RAI 4, R-ISS II, R-ISS III, III, IV, PROGRESSIVE/REFRACTORY, RECURRENT/RELAPSED (RAI, R-ISS, Lugano)
RAI staging of intermediate (1 and 2) or high (3 and 4); R-ISS stage II or, III; Stage III or above (IV, Progressive/refractory, or recurrent/relapsed stage) according to the Lugano Classification
Prior therapy
Cannot have received: hematopoietic stem cell transplant
Participants with documented history of hematopoietic stem cell transplant
Cannot have received: immunoglobulin replacement therapy
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
Lab requirements
Kidney function
eGFR < 30 mL/min/1.73 m2 excluded
Liver function
ALT, AST, GGT, or LDH > 3x ULN excluded
liver enzyme levels (ALT, AST, GGT, or LDH) greater than 3 times the upper limit of normal (ULN) at the Screening Visit...severe known kidney disease [as defined by eGFR < 30 mL/min/1.73 m2]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- GC2202 Study Site 103 · St. Petersburg, Florida
- GC2202 Study Site 111 · Bethesda, Maryland
- GC2202 Study Site 109 · Greenville, North Carolina
- GC2202 Decentralized Study Site 114 · Morrisville, North Carolina
- GC2202 Study Site 105 · Canton, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify