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

NCT07081022 | Recruiting Phase 2

• 1 other identifier: JS203-002-II-B-NHL
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

B-cell Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Objective response rate (ORR) based on 2014 Lugano criteria

  up to approximately 15 months

Secondary Outcomes (10)

• complete response (CR)

  up to approximately 24 months

• Duration of response (DoR)

  up to approximately 24 months

• Duration of complete response (DoCR)

  up to approximately 24 months

• Time to response (TTR)

  up to approximately 24 months

• Progression-free survival (PFS)

  up to approximately 24 months

Study Arms (6)

DLBCL-Gemox

EXPERIMENTAL

In participants with relapsed/refractory diffuse large B cell lymphoma ineligible for ASCT

Drug: JS203 in combination with gemcitabine and oxaliplatin

DLBCL-ICE

EXPERIMENTAL

In participants with relapsed/refractory diffuse large B cell lymphoma intended for ASCT

Drug: JS203 in combination with ifosfamide, carboplatin and etoposide

DLBCL- RCHOP

EXPERIMENTAL

In participants with newly diagnosed diffuse large B cell lymphoma

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

FL-Lena

EXPERIMENTAL

In participants with relapsed/refractory follicular lymphoma

Drug: JS203 combined with lenalidomide

MCL-Lena

EXPERIMENTAL

In participants with relapsed/refractory mantle cell lymphoma

Drug: JS203 combined with lenalidomide

MZL-Lena

EXPERIMENTAL

In participants with relapsed/refractory marginal zone lymphoma

Drug: JS203 combined with lenalidomide

Interventions

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.

DLBCL-Gemox

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.

DLBCL-ICE

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.

DLBCL- RCHOP

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.

FL-Lena; MCL-Lena; MZL-Lena

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 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；

You may not qualify if:

• 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)；

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Gemcitabine; Oxaliplatin; Ifosfamide; Carboplatin; Etoposide; Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Lenalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Oxazines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles

Central Study Contacts

Bang.an Peng, Master

CONTACT

13526844722; bang.an_peng@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: August 17, 2025
• Primary Completion (Estimated): April 6, 2027
• Study Completion (Estimated): April 6, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)