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NCT Number: NCT07081022

JS203 Combination Regimens in B-Cell Non-Hodgkin's Lymphoma

To evaluate the preliminary efficacy of JS203 combined with standard regimens in patients with B-cell Non-Hodgkin's lymphoma

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location status: Recruiting

Location contact

Yuqin Song, Ph.D

CONTACT

[email protected]

010-88196118

Yuqin Song, Ph.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients must meet all of the following inclusion criteria to be enrolled:

  • Age range: 18 to 80 years old (inclusive), both male and female are acceptable;
  • ECOG: 0-2;
  • B-cell non-Hodgkin's lymphoma expressing CD20 antigen that has been pathologically diagnosed;
  • At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment; Acceptable organ function at screening;

Exclusion criteria

  • A history of severe allergy to monoclonal antibody therapy (or recombinant antibody-related fusion protein);
  • Previously received CD20-CD3 bispecific antibody treatment;
  • Previous allogeneic hematopoietic stem cell transplantation;
  • Previous solid organ transplantation;
  • History of autoimmune diseases;
  • Patients with a history of macrophage activation syndrome (MAS)/ hemophagocytic lymphohistiocytosis (HLH);
  • Patients with a history of progressive multifocal leukoencephalopathy (PML);
  • A known or suspected history of CNS lymphoma (including primary or secondary);
  • There is pleural effusion, peritoneal effusion or pericardial effusion that requires treatment (such as puncture or drainage);

Treatment and study plan

JS203 in combination with gemcitabine and oxaliplatin

Drug

Gemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days/cycle) Cycle 1 QW,Cycle 2 and therafter Q3W until progression or unacceptable toxicity.

JS203 in combination with ifosfamide, carboplatin and etoposide

Drug

Ifosfamide, carboplatin and etoposide, 3 cycles (Q3W) and JS203, Cycle 1 QW, Cycle 2 and therafter Q3W until trasnplant, progression or unacceptable toxicity.

JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone

Drug

Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone 6 cycles (Q3W) and JS203, 8 cycles (21 days/cycle), Cycle 1 QW, Cycle 2 to Cycle 8 Q3W.

JS203 combined with lenalidomide

Drug

lenalidomide,12 cycles, Cycle 1(Q3W), Cycle 2 to Cycle 12 (Q4W) and JS203, 12 cycles, Cycle 1 (21 days/cycle) QW, Cycle 2 to Cycle 12 (28 days/cycle) Q4W.

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: up to approximately 15 months

    Objective response rate (ORR) based on 2014 Lugano criteria

Secondary outcomes

  1. complete response (CR)

    Time frame: up to approximately 24 months

    The complete response rate (CR) evaluated based on 2014 Lugano criteria

  2. Duration of response (DoR)

    Time frame: up to approximately 24 months

    Duration of response (DoR) evaluated based on 2014 Lugano criteria

  3. Duration of complete response (DoCR)

    Time frame: up to approximately 24 months

    Duration of complete response (DoCR) evaluated based on 2014 Lugano criteria

  4. Time to response (TTR)

    Time frame: up to approximately 24 months

    Time to response (TTR) evaluated based on 2014 Lugano criteria

  5. Progression-free survival (PFS)

    Time frame: up to approximately 24 months

    Progression-free survival (PFS) evaluated based on 2014 Lugano criteria

  6. Overall survival (OS)

    Time frame: up to approximately 24 months

    Overall survival (OS) evaluated based on 2014 Lugano criteria

  7. Adverse events (AE)

    Time frame: up to approximately 24 months

    Incidence and severity of all adverse events (AE) that occurred during the clinical trial

  8. PK

    Time frame: up to approximately 24 months

    The serum drug concentration of JS203

  9. ADA

    Time frame: up to approximately 24 months

    The incidence and titer of the anti-drug antibody (ADA) of JS203

  10. NAb

    Time frame: Up to approximately 24 months

    The incidence of neutralizing antibodies (NAb) of JS203 (if applicable)

Study contacts

Contact information is provided by the study sponsor or research team.

Bang.an Peng, Master

CONTACT

[email protected]

13526844722

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2025
Registry last updated
Aug 21, 2025

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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