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DLBCL - Diffuse Large B Cell LymphomaPhase 3NCT07570823

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

A Phase 3 study testing SCTB35 injection, Rituxumab and Gemcitabine in people with DLBCL - Diffuse Large B Cell Lymphoma, run by Sinocelltech Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
DLBCL - Diffuse Large B Cell Lymphoma
What is being tested?
SCTB35 injection, Rituxumab and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteChina
Study dates
4 Jun 2026to Apr 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Yuqin Song, M.D., 010-88196118, SongYQ_VIP@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

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.

Being tested
SCTB35 injection, Rituxumab, Gemcitabine, Oxaliplatin
Medical subject headings
Dendritic Cell Sarcoma, Interdigitating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCTB35 injectionDrug

    SCTB35 will be subcutaneously administered at a dose as specified

  • RituxumabDrug

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

  • GemcitabineDrug

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

  • OxaliplatinDrug

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

Study groups in NCT07570823
Study groupRoleWhat they receive
SCTB35-GemOxExperimentalNot described
Receives: Drug: SCTB35 injection; Drug: Gemcitabine; Drug: Oxaliplatin
R-GemOxActive comparatorNot described
Receives: Drug: Rituxumab; Drug: Gemcitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

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

    Measured: Up to approximately 3 years

  2. 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.

    Measured: Up to approximately 3 years

Secondary outcomes (10)

  1. Overall Survival (OS)

    Overall survival is defined as the duration from the date of randomization to the date of the participant's death.

    Measured: Up to approximately 3 years

  2. Percentage of Participants Achieving Best Overall Response (BOR)

    BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria

    Measured: Up to approximately 3 years

  3. Percentage of Participants Achieving CR

    Percentage of participants who achieve a CR determined per Lugano criteria.

    Measured: Up to approximately 3 years

  4. Duration of Response (DOR)

    DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.

    Measured: Up to approximately 3 years

  5. Duration of Complete Response (DOCR)

    DOCR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first.

    Measured: Up to approximately 3 years

  6. Time to Response (TTR)

    Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.

    Measured: Up to approximately 3 years

  7. Time to Complete Response (TTCR)

    Time to complete response is defined for participants achieving a CR as the time from starting therapy to first a CR.

    Measured: Up to approximately 3 years

  8. Event-Free Survival (EFS)

    EFS is defined as the duration from randomization to disease progression determined by Lugano criteria as assessed by the investigator, initiation of any non-protocol-specified new anti-lymphoma therapy for any reason, or death (whichever occurs first).

    Measured: Up to approximately 3 years

  9. Blood Concentrations of SCTB35

    The pharmacokinetics of SCTB35 will be analyzed based on the drug concentrations at respective timepoints in the blood samples (or blood derivative)

    Measured: Up to approximately 1 years

  10. Anti-drug Antibodies of SCTB35

    Blood samples (or blood derivative) will be screened for antibodies binding to SCTB35

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start4 Jun 2026
  3. Primary completionNov 2027 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07570823
Sponsor's protocol ID
SCTB35-B301
Status last verified
Aug 2026
First submitted
29 Apr 2026
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SCTB35 injection, Rituxumab and Gemcitabine in people with DLBCL - Diffuse Large B Cell Lymphoma, run by Sinocelltech Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07570823.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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