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OncoMatch/Clinical Trials/NCT06806033

Evaluate Optimization of CRS Profile for Glofit Monotherapy and Glofit+GemOx in R/R Aggressive B-NHL

Official title: A Phase II, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab Monotherapy and Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Is NCT06806033 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Obinutuzumab and Glofitamab for relapsed or refractory aggressive b-cell non-hodgkins lymphoma.

Phase 2RecruitingHoffmann-La RocheNCT06806033Data as of Oct 2026Location: International · 7 countries

Treatment: Obinutuzumab · Glofitamab · Gemcitabine · Oxaliplatin — This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) followed by glofitamab monotherapy treatment regimen (Cohort A), and for glofitamab monotherapy (Cohort B) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

ObinutuzumabGlofitamab

Chemotherapy

GemcitabineOxaliplatin

Cancer type

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: systemic therapy

At least one line of prior systemic therapy. R/R disease, defined as: relapsed = disease that has recurred following a response that lasted >= 6 months after completion of the last line of therapy; refractory = disease that did not respond to or that progressed < 6 months after completion of the last line of therapy.

Cannot have received: glofitamab or other bispecific antibodies targeting both CD20 and CD3

Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.

Cannot have received: gemcitabine (gemcitabine)

Exception: Cohort A only

For the Glofit-GemOx combination therapy cohort (Cohort A), prior treatment with gemcitabine or oxaliplatin.

Cannot have received: oxaliplatin (oxaliplatin)

Exception: Cohort A only

For the Glofit-GemOx combination therapy cohort (Cohort A), prior treatment with gemcitabine or oxaliplatin.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Alaska Oncology & Hematology, LLC · Anchorage, Alaska
  • Community Cancer Institute (CCI) · Clovis, California
  • Providence Medical Foundation · Fullerton, California
  • Los Angeles Cancer Network · Glendale, California
  • Valkyrie Clinical Trials · Los Angeles, California

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06806033 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior glofitamab or other bispecific antibodies targeting both CD20 and CD3, gemcitabine, oxaliplatin disqualifies patients from enrollment.

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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