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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

11 augusti 2026 uppdaterad av: Sinocelltech Ltd.

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

101

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
      • Beijing, Kina, 100142
        • Rekrytering
        • Beijing Cancer Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: R-GemOx
Läkemedel: Rituxumab
Deltagarna kommer att få IV rituxumab på dag 1 av varje cykel i upp till 8 cykler.
Läkemedel: Gemcitabine
Participants will receive IV gemcitabine administration for up to 8 cycles.
Läkemedel: Oxaliplatin
Participants will receive IV oxaliplatin administration for up to 8 cycles.
Experimentell: SCTB35-GemOx
Läkemedel: SCTB35 injection
SCTB35 will be subcutaneously administered at a dose as specified
Läkemedel: Gemcitabine
Participants will receive IV gemcitabine administration for up to 8 cycles.
Läkemedel: Oxaliplatin
Participants will receive IV oxaliplatin administration for up to 8 cycles.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adverse Events
Tidsram: Up to approximately 3 years
Treatment-emergent adverse events/serious adverse events/adverse events of special interest
Up to approximately 3 years
Progression free survival (PFS)
Tidsram: Up to approximately 3 years
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Achieving Best Overall Response (BOR)
Tidsram: Up to approximately 3 years
BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria
Up to approximately 3 years
Percentage of Participants Achieving CR
Tidsram: Up to approximately 3 years
Percentage of participants who achieve a CR determined per Lugano criteria.
Up to approximately 3 years
Overall Survival (OS)
Tidsram: Up to approximately 3 years
Overall survival is defined as the duration from the date of randomization to the date of the participant's death.
Up to approximately 3 years
Duration of Response (DOR)
Tidsram: Up to approximately 3 years
DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
Up to approximately 3 years
Time to Response (TTR)
Tidsram: Up to approximately 3 years
Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.
Up to approximately 3 years
Event-Free Survival (EFS)
Tidsram: Up to approximately 3 years
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).
Up to approximately 3 years
Duration of Complete Response (DOCR)
Tidsram: Up to approximately 3 years
DOCR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first.
Up to approximately 3 years
Time to Complete Response (TTCR)
Tidsram: Up to approximately 3 years
Time to complete response is defined for participants achieving a CR as the time from starting therapy to first a CR.
Up to approximately 3 years
Blood Concentrations of SCTB35
Tidsram: Up to approximately 1 years
The pharmacokinetics of SCTB35 will be analyzed based on the drug concentrations at respective timepoints in the blood samples (or blood derivative)
Up to approximately 1 years
Anti-drug Antibodies of SCTB35
Tidsram: Up to approximately 3 years
Blood samples (or blood derivative) will be screened for antibodies binding to SCTB35
Up to approximately 3 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sinocelltech Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 juni 2026

Primärt slutförande (Beräknad)

1 november 2027

Avslutad studie (Beräknad)

1 april 2029

Studieregistreringsdatum

Först inskickad

29 april 2026

Först inskickad som uppfyllde QC-kriterierna

29 april 2026

Första postat (Faktisk)

6 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SCTB35-B301

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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