B-cell Non-Hodgkin's LymphomaPhase 2NCT07081022
JS203 Combination Regimens in B-Cell Non-Hodgkin's Lymphoma
A Phase 2 study testing JS203 in combination with gemcitabine and oxaliplatin, JS203 in combination with ifosfamide, carboplatin and etoposide and JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone in people with B-cell Non-Hodgkin's Lymphoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
To evaluate the preliminary efficacy of JS203 combined with standard regimens in patients with B-cell Non-Hodgkin's lymphoma Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- JS203 in combination with gemcitabine and oxaliplatin, JS203 in combination with ifosfamide, carboplatin and etoposide and JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2025to 6 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
Who cannot join
- 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)；
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- 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)；
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- JS203 in combination with gemcitabine and oxaliplatin, JS203 in combination with ifosfamide, carboplatin and etoposide, JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, JS203 combined with lenalidomide
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS203 in combination with gemcitabine and oxaliplatinDrug
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 etoposideDrug
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 prednisoneDrug
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 lenalidomideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| DLBCL-Gemox | Experimental | In participants with relapsed/refractory diffuse large B cell lymphoma ineligible for ASCT Receives: Drug: JS203 in combination with gemcitabine and oxaliplatin |
| DLBCL-ICE | Experimental | In participants with relapsed/refractory diffuse large B cell lymphoma intended for ASCT Receives: Drug: JS203 in combination with ifosfamide, carboplatin and etoposide |
| DLBCL- RCHOP | Experimental | In participants with newly diagnosed diffuse large B cell lymphoma Receives: Drug: JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone |
| FL-Lena | Experimental | In participants with relapsed/refractory follicular lymphoma Receives: Drug: JS203 combined with lenalidomide |
| MCL-Lena | Experimental | In participants with relapsed/refractory mantle cell lymphoma Receives: Drug: JS203 combined with lenalidomide |
| MZL-Lena | Experimental | In participants with relapsed/refractory marginal zone lymphoma Receives: Drug: JS203 combined with lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate (ORR) based on 2014 Lugano criteria
Measured: up to approximately 15 months
Secondary outcomes (10)
complete response (CR)
The complete response rate (CR) evaluated based on 2014 Lugano criteria
Measured: up to approximately 24 months
Duration of response (DoR)
Duration of response (DoR) evaluated based on 2014 Lugano criteria
Measured: up to approximately 24 months
Duration of complete response (DoCR)
Duration of complete response (DoCR) evaluated based on 2014 Lugano criteria
Measured: up to approximately 24 months
Time to response (TTR)
Time to response (TTR) evaluated based on 2014 Lugano criteria
Measured: up to approximately 24 months
Progression-free survival (PFS)
Progression-free survival (PFS) evaluated based on 2014 Lugano criteria
Measured: up to approximately 24 months
Overall survival (OS)
Overall survival (OS) evaluated based on 2014 Lugano criteria
Measured: up to approximately 24 months
Adverse events (AE)
Incidence and severity of all adverse events (AE) that occurred during the clinical trial
Measured: up to approximately 24 months
PK
The serum drug concentration of JS203
Measured: up to approximately 24 months
ADA
The incidence and titer of the anti-drug antibody (ADA) of JS203
Measured: up to approximately 24 months
NAb
The incidence of neutralizing antibodies (NAb) of JS203 (if applicable)
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start17 Aug 2025
- Primary completion6 Apr 2027 (estimated)
- Study completion6 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081022
- Sponsor's protocol ID
- JS203-002-II-B-NHL
- Status last verified
- Sep 2026
- First submitted
- 15 Jul 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JS203 Combination Regimens in B-Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT07081022
- Acronym / sponsor ID
- JS203-002-II-B-NHL
- Conditions
- B-cell Non-Hodgkin's Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 17 Aug 2025 (actual)
- Primary completion
- 6 Apr 2027 (estimated)
- Study completion
- 6 Apr 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the preliminary efficacy of JS203 combined with standard regimens in patients with B-cell Non-Hodgkin's lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| DLBCL-Gemox | Experimental | Drug: JS203 in combination with gemcitabine and oxaliplatinIn participants with relapsed/refractory diffuse large B cell lymphoma ineligible for ASCT |
| DLBCL-ICE | Experimental | Drug: JS203 in combination with ifosfamide, carboplatin and etoposideIn participants with relapsed/refractory diffuse large B cell lymphoma intended for ASCT |
| DLBCL- RCHOP | Experimental | Drug: JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisoneIn participants with newly diagnosed diffuse large B cell lymphoma |
| FL-Lena | Experimental | Drug: JS203 combined with lenalidomideIn participants with relapsed/refractory follicular lymphoma |
| MCL-Lena | Experimental | Drug: JS203 combined with lenalidomideIn participants with relapsed/refractory mantle cell lymphoma |
| MZL-Lena | Experimental | Drug: JS203 combined with lenalidomideIn participants with relapsed/refractory marginal zone lymphoma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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；
Key exclusion criteria (9 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS203 in combination with gemcitabine and oxaliplatinGemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days/cycle) Cycle 1 QW,Cycle 2 and therafter Q3W until progression or unacceptable toxicity. | Drug | DLBCL-Gemox |
| JS203 in combination with ifosfamide, carboplatin and etoposideIfosfamide, carboplatin and etoposide, 3 cycles (Q3W) and JS203, Cycle 1 QW, Cycle 2 and therafter Q3W until trasnplant, progression or unacceptable toxicity. | Drug | DLBCL-ICE |
| JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisoneRituximab, cyclophosphamide, doxorubicin, vincristine and prednisone 6 cycles (Q3W) and JS203, 8 cycles (21 days/cycle), Cycle 1 QW, Cycle 2 to Cycle 8 Q3W. | Drug | DLBCL- RCHOP |
| JS203 combined with lenalidomidelenalidomide,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. | Drug | FL-Lena, MCL-Lena, MZL-Lena |
Primary outcome
Objective response rate (ORR)
Time frame: up to approximately 15 months
Objective response rate (ORR) based on 2014 Lugano criteria
10 secondary outcomes
complete response (CR)
Time frame: up to approximately 24 months
Duration of response (DoR)
Time frame: up to approximately 24 months
Duration of complete response (DoCR)
Time frame: up to approximately 24 months
Time to response (TTR)
Time frame: up to approximately 24 months
Progression-free survival (PFS)
Time frame: up to approximately 24 months
Overall survival (OS)
Time frame: up to approximately 24 months
Adverse events (AE)
Time frame: up to approximately 24 months
PK
Time frame: up to approximately 24 months
ADA
Time frame: up to approximately 24 months
NAb
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JS203 in combination with gemcitabine and oxaliplatin, JS203 in combination with ifosfamide, carboplatin and etoposide and JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone in people with B-cell Non-Hodgkin's Lymphoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to approximately 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.