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 (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT05645107 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hematopoietic stem cell transplant, immunoglobulin replacement therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage RAI 1 or RAI 2 or RAI 3 or RAI 4 or R-ISS II or R-ISS III or III or IV or PROGRESSIVE/REFRACTORY or RECURRENT/RELAPSED is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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