JS203 combined with standard treatments for CD20-positive B-cell non-Hodgkin's lymphoma

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

This trial will try JS203 with several standard chemotherapy and immunotherapy regimens in adults with CD20-positive B-cell non-Hodgkin's lymphoma to see if it improves responses.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07081022 on ClinicalTrials.gov

What this trial studies

This is a phase 2 interventional trial testing JS203 given in combination with multiple standard regimens (including gemcitabine/oxaliplatin, ICE, R-CHOP, and lenalidomide-containing therapy) in patients with CD20-positive B-cell non-Hodgkin's lymphoma. The study enrolls adults 18–80 years with measurable disease and ECOG performance status 0–2 and monitors preliminary efficacy outcomes such as response rates and duration of response. Key exclusions include prior CD20–CD3 bispecific therapy, prior allogeneic transplant, autoimmune disease, MAS/HLH, PML, and CNS lymphoma. The trial is sponsored by Shanghai Junshi Bioscience and conducted at Beijing Cancer Hospital.

Who should consider this trial

Good fit: Adults aged 18 to 80 with pathologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma, ECOG 0–2, measurable disease per Lugano 2014 and acceptable organ function are the intended participants.

Not a fit: Patients with prior CD20‑CD3 bispecific antibody treatment, prior allogeneic stem cell or solid organ transplant, autoimmune disease, history of MAS/HLH or PML, CNS lymphoma, or severe allergy to monoclonal antibodies are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding JS203 to standard regimens could increase response rates and lengthen remissions for people with CD20-positive B-cell NHL.

How similar studies have performed: Early-phase studies of other CD20-targeted bispecifics and combination regimens in B-cell NHL have shown encouraging responses, but JS203 combinations are novel and need confirmation in phase 2.

Eligibility criteria

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)；

Where this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Bang.an Peng, Master

Conditions B-cell Non-Hodgkin's Lymphoma