Glofitamab combo vs Rituximab combo with chemo for relapsed/refractory DLBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, randomized, open-label trial conducted at multiple centers. It compares JS203-GemOx to R-GemOx in adults with relapsed or refractory diffuse large B-cell lymphoma. Participants will receive either JS203 combined with gemcitabine and oxaliplatin or rituximab with gemcitabine and oxaliplatin, with safety and efficacy outcomes tracked. Eligible patients are 18 to 75 years old, with good performance status and measurable disease, and CD20-positive DLBCL subtypes. The study is led by Shanghai Junshi Bioscience with center(s) in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must meet all of the following inclusion criteria to be enrolled:
* Age range: 18 to 75 years old (inclusive), both male and female are acceptable
* ECOG: 0-1；
* One of the confirmed histologies below with CD20-positivity:

DLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL)/Marginal Zone Lymphoma(MZL) "Double-hit" or "triple-hit" DLBCL , including de novo or histologically transformed from FL/MZL FL Grade 3B T-cell/histiocyte-rich large B-cell lymphoma

* At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment；
* Acceptable organ function at screening；

Exclusion Criteria:

* A history of severe allergy to monoclonal antibody therapy (or recombinant antibody-related fusion protein)；
* Previously received CD20-CD3 bispecific antibody treatment；
* Previous allogeneic hematopoietic stem cell transplantation；
* Previous solid organ transplantation
* History of autoimmune diseases
* Patients with a history of macrophage activation syndrome (MAS)/ hemophagocytic lymphohistiocytosis (HLH)
* Patients with a history of progressive multifocal leukoencephalopathy (PML)
* A known or suspected history of CNS lymphoma (including primary or secondary)
* There is pleural effusion, peritoneal effusion or pericardial effusion that requires treatment (such as puncture or drainage)

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Niannian Wang
• Email: niannian_wang@junshipharma.com
• Phone: 13161547878

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.