A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NCT07570823 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SCTB35-B301
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of SCTB35 in Combination With Gemcitabine and Oxaliplatin vs Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Treatment-emergent adverse events/serious adverse events/adverse events of special interest

  Up to approximately 3 years

• Progression free survival (PFS)

  Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.

  Up to approximately 3 years

Secondary Outcomes (10)

• Overall Survival (OS)

  Up to approximately 3 years

• Percentage of Participants Achieving Best Overall Response (BOR)

  Up to approximately 3 years

• Percentage of Participants Achieving CR

  Up to approximately 3 years

• Duration of Response (DOR)

  Up to approximately 3 years

• Duration of Complete Response (DOCR)

  Up to approximately 3 years

Study Arms (2)

SCTB35-GemOx

EXPERIMENTAL

Drug: SCTB35 injection; Drug: Gemcitabine; Drug: Oxaliplatin

R-GemOx

ACTIVE COMPARATOR

Drug: Rituxumab; Drug: Gemcitabine; Drug: Oxaliplatin

Interventions

Rituxumab DRUG

Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.

R-GemOx

Gemcitabine DRUG

Participants will receive IV gemcitabine administration for up to 8 cycles.

R-GemOx; SCTB35-GemOx

Oxaliplatin DRUG

Participants will receive IV oxaliplatin administration for up to 8 cycles.

R-GemOx; SCTB35-GemOx

SCTB35 injection DRUG

SCTB35 will be subcutaneously administered at a dose as specified

SCTB35-GemOx

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

Location

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Interventions

Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)