SCTB35 with Gemcitabine and Oxaliplatin in relapsed or 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 interventional study evaluating SCTB35 in combination with gemcitabine and oxaliplatin versus rituximab with gemcitabine and oxaliplatin in adults whose diffuse large B-cell lymphoma has returned or not responded after prior therapy. Eligible participants are 18-80 years old, with measurable disease and adequate organ function, and a performance status of 0-2. Key exclusions include prior therapies targeting both CD20 and CD3, and contraindications to the study drugs. The trial is led by Sinocelltech Ltd. with Beijing Cancer Hospital as a site, and aims to determine if SCTB35 can improve outcomes in a difficult-to-treat population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-80 years old
* Histologically confirmed diffuse large B-cell lymphoma according to WHO 2022 criteria
* Relapsed or refractory (R/R) disease following at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy
* Participants who have failed after one prior line of therapy are not candidates for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
* Presence of measurable or evaluable disease at baseline ECOG PS 0-2
* ECOG PS 0-2
* Adequate organ function and bone marrow function
* Expected survival ≥ 3 months

Exclusion Criteria:

* Prior treatment with antibodies targeting both CD20 and CD3
* Contraindication to rituximab, gemcitabine or oxaliplatin, or prior treatment with an anti-CD20 antibody in combination with the GemOx regimen
* Peripheral neuropathy assessed to be Grade \>1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0 at enrollment
* Known central nervous system (CNS) involvement by lymphoma
* Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks
* Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to first SCTB35 administration
* Autologous HSCT within 100 days prior to first SCTB35 administration, or any prior allogeneic HSCT or solid organ transplantation
* Major surgery within 4 weeks prior to first SCTB35 administration
* Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to first SCTB35 administration
* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study

Where it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting

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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.