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 (Sep 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
Biomarker criteria
Required: IGHG1 expression (< 5 g/L)
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.)
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 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)
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) > 3x ULN excluded; severe known kidney disease [eGFR < 30 mL/min/1.73 m2] excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- GC2202 Study Site 115 · Huntington Park, California
- 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
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.
Does this trial require IGHG1?
Yes, IGHG1 expression is a required biomarker for 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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