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NCT Number: NCT07819188

SCTB35 and SCTB41 With or Without Chemotherapy in Non-Hodgkin Lymphoma

The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of SCTB35 and SCTB41 With or Without Chemotherapy in non-Hodgkin's lymphoma patients.

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Key information

Conditions

NHL - Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjing, 301636, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 to 80 years (inclusive) at the time of informed consent
  • Histologically or cytologically confirmed B cell neoplasm.
  • Phase 1: Relapsed or refractory disease after at least two prior systemic therapy.
  • Measurable or evaluable disease at enrollment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Adequate organ and bone marrow function
  • Life expectancy of ≥ 3 months

Exclusion criteria

  • Prior treatment with bispecific antibodies targeting both CD20 and CD3
  • Prior treatment with antibodies targeting both PD-1/PD-L1, PD-(L)1/VEGF(R) or PD-(L)1/TGF-β
  • Eligible for high dose chemotherapy followed by hematopoietic stem cell transplantation (HSCT)
  • Known central nervous system (CNS) involvement by lymphoma
  • Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks
  • Chemotherapy and other non-investigational antineoplastic agents within 4 weeks or 5 half-lives (whichever is shorter) prior to first SCTB35 administration

Treatment and study plan

SCTB35 injection

Drug

SCTB35 will be subcutaneously administered at a dose as specified

SCTB41

Drug

SCTB41 will be IV administered at a dose as specified

Primary outcomes

  1. Phase 1: dose limited toxicity (DLT)

    Time frame: Within 28 days of the first administration

    To determine the maximum tolerated dose (MTD) and/or RP2D to be studied in the dose-expansion part

  2. Phase 2: Percentage of Participants Achieving Objective Response Rate (ORR)

    Time frame: Up to approximately 3 years

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

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 3 years

    Overall survival is defined as the time from randomization to death from any cause.

  2. Progression free survival (PFS)

    Time frame: 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.

  3. Percentage of Participants Achieving CR

    Time frame: Up to approximately 3 years

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

  4. Duration of Response (DOR)

    Time frame: Up to approximately 3 years

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

  5. Duration of Complete Response (DOCR)

    Time frame: Up to approximately 3 years

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

  6. Time to Response (TTR)

    Time frame: Up to approximately 3 years

    Time to response (TTR) is defined as the time from the start of therapy to the first documented CR or PR in patients who achieve an objective response

  7. Time to Complete Response (TTCR)

    Time frame: Up to approximately 3 years

    TTCR is defined as the time from the start of therapy to the first documented CR among patients with a complete response.

  8. Adverse Events

    Time frame: Up to approximately 3 years

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

  9. Blood Concentrations of SCTB35 and SCTB41

    Time frame: Up to approximately 6 months

    Pharmacokinetics of SCTB35 and SCTB41 will be assessed using drug concentrations measured in plasma (or serum) at specified time points.

  10. Anti-drug Antibodies of SCTB35 and SCTB41

    Time frame: Up to approximately 3 years

    Serum (or plasma) samples will be tested for the presence of anti-drug antibodies (ADAs) against SCTB35 and SCTB41

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Sinocelltech Ltd.

Industry

Registry information

Official study title

A Phase Ib/II Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of SCTB35 in Combination With SCTB41, With or Without Concomitant Chemotherapy, in Patients With Non-Hodgkin's Lymphoma.

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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