AzTrials
AzTrials

Relapsed/Refractory B-cell Non-Hodgkin's LymphomaPhase 1NCT05618327

Phase I Clinical Study of JS203 in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

A Phase 1 study testing JS203 for Injection in people with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is an open phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity, and preliminary efficacy of JS203 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
JS203 for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteChina
Study dates
13 Feb 2023to 30 Dec 2026
Phase
Phase 1
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understand and voluntarily sign the informed consent form.
  • Age 18 - 75 years (both 18 and 75 years), both sexes
  • Expected survival of ≥ 12 weeks.
  • Eastern Collaborative Oncology Group (ECOG) physical status score: 0 to 1.
  • B-cell non-Hodgkin's lymphoma expressing CD20 antigen clearly diagnosed by pathology
  • Patients with non-Hodgkin's lymphoma must have measurable lesions that meet the Lugano 2014 criteria for lymphoma efficacy assessment, requiring lymph node lesions >1.5 cm in either length or extra-nodal lesions >1.0 cm in either length.

Who cannot join

  • history of severe allergy or anaphylactic reaction to monoclonal antibody therapy (or recombinant antibody-associated fusion protein).
  • previous treatment with CD20-CD3 bispecific antibodies.
  • failure to resolve toxicity after prior antitumor therapy, i.e., no return to baseline or grade 0-1 as defined by NCI-CTCAE 5.0 (except for alopecia, hyperpigmentation). Irreversible toxicity that is not reasonably expected to be exacerbated by the study drug and may be enrolled upon confirmation with the sponsor.
  • Received antitumor therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or biologic therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose. Non-tumor related conditions that are amenable to hormone therapy (e.g. insulin therapy for diabetes and hormone replacement therapy).
  • receive autologous hematopoietic stem cell transplantation within 100 days prior to the first dose
  • have undergone, or are expected to require during the study period, major surgery (as judged by the investigator) or are recovering from surgery within 4 weeks prior to the first dose
Show all 12Show fewer
  • active hepatitis B or C. Active hepatitis B defined as positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) with HBV DNA above the upper limit of the study center's normal value; active hepatitis C defined as positive for hepatitis C antibody and HCV RNA above the upper limit of the study center's normal value.
  • history of cardiac disease: New York Heart Association (NYHA) > Class II congestive heart failure, myocardial infarction occurring within 6 months prior to enrollment, or arrhythmia requiring antiarrhythmic therapy and/or left ventricular ejection fraction < 50%.
  • two or more malignancies within 5 years prior to the first dose. Except for early malignancies that have been eradicated (carcinoma in situ or stage I tumors), such as adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer.
  • persons with uncontrollable psychiatric disorders
  • patients with a history of drug abuse or alcohol abuse
  • other conditions judged by the investigator to be inappropriate for participation in this study, including but not limited to having any disease or medical history that may confound study results and interfere with patient compliance

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

This is an open phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity, and preliminary efficacy of JS203 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. The study is divided into three phases: a dose-escalation phase, a dose-expansion phase, and an efficacy expansion phase.

Being tested
JS203 for Injection
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 for InjectionDrug

    2-steps:JS203 for Injection is administered on the first and eighth day of the first cycle and every 3 weeks thereafter.

    3-steps:JS203 for Injection is administered on the first, eighth and fifteenth day of the first cycle and every 3 weeks thereafter.

    4-steps:JS203 for Injection is administered on the first, eighth, fifteenth and twenty-second day of the first cycle and every 3 weeks thereafter.

Study groups in NCT05618327
Study groupRoleWhat they receive
JS203ExperimentalNot described
Receives: Drug: JS203 for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD

    It is suitable for dose escalation and dose extension.If the number of DLT patients is 0 and the next higher dose is unacceptable, the current dose is declared MTD.

    Measured: Throughout the dose escalation and dose expansion phases,, an average of 1.5 years

  2. RP2D

    It is suitable for dose escalation and dose extension.RP2D will be determined based on a combination of safety, tolerability, PK and/or pharmacodynamic studies .

    Measured: Throughout the dose escalation and dose expansion phases, an average of 1.5 years

Secondary outcomes (20)

  1. DLT events

    Incidence and severity of DLT events.

    Measured: Up to 2 years

  2. Adverse events (AEs)

    Incidence and severity of adverse events (AEs)

    Measured: Up to 2 years

  3. Serious adverse events (SAEs)

    Incidence and severity of serious adverse events (SAEs).

    Measured: Up to 2 years

  4. abnormal changes in clinically significant laboratory tests and other examinations

    abnormal changes in clinically significant laboratory tests and other examinations

    Measured: Up to 2 years

  5. Objective Response Rate (ORR)

    Objective Response Rate (ORR) as Assessed by Investigator according to Lugano 2014

    Measured: Up to 2 years

  6. Complete Response (CR)

    Complete Response (CR) as Assessed by Investigator according to Lugano 2014

    Measured: Up to 2 years

  7. Duration of Objective Response (DOR)

    Duration of Objective Response (DOR) as Assessed by Investigator

    Measured: Up to 2 years

  8. Duration of Complete Response (DOCR)

    Duration of Complete Response (DOCR) as Assessed by Investigator

    Measured: Up to 2 years

  9. Time to Response(TTR)

    Time to Response(TTR) as Assessed by Investigator

    Measured: Up to 2 years

  10. Progression-Free Survival (PFS)

    Progression-Free Survival (PFS) as Determined by Investigator

    Measured: Up to 2 years

  11. Overall Survival (OS)

    Overall Survival (OS)

    Measured: Up to 2 years

  12. Antidrug antibodies (ADA) and/or neutralizing antibodies (Nab)

    incidence of antidrug antibodies (ADA) and/or neutralizing antibodies (Nab)

    Measured: At pre-defined intervals up to 2 years

  13. Total exposure(AUC) of JS203

    Total exposure(AUC) of JS203

    Measured: At pre-defined intervals up to 2 years

  14. Maximum Plasma Concentration (Cmax) of JS203

    Maximum Plasma Concentration (Cmax) of JS203

    Measured: At pre-defined intervals up to 2 years

  15. Half-life(T1/2) of JS203

    Half-life(T1/2) of JS203

    Measured: At pre-defined intervals up to 2 years

  16. Clearance(CL) of JS203

    Clearance(CL) of JS203

    Measured: At pre-defined intervals up to 2 years

  17. Volume of Distribution (Vss) of JS203

    Volume of Distribution (Vss) of JS203

    Measured: At pre-defined intervals up to 2 years

  18. Pharmacodynamic (PD) characteristics

    CD20 receptor occupancy rate in peripheral blood cells

    Measured: At pre-defined interval up to 2 years

  19. Pharmacodynamic (PD) characteristics

    Changes in peripheral blood immune cell subtypes (B cells, T cells) before and after drug administration.

    Measured: At pre-defined interval up to 2 years

  20. Pharmacodynamic (PD) characteristics

    Changes in peripheral blood cytokines (IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ) before and after drug administration

    Measured: At pre-defined interval up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2022
  2. Study start13 Feb 2023
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05618327
Sponsor's protocol ID
JS203-001-I
Status last verified
Dec 2025
First submitted
20 Oct 2022
Last updated
2 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JS203 for Injection in people with Relapsed/Refractory 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 6 inclusion and 12 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 2 Dec 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

MTD (time frame: Throughout the dose escalation and dose expansion phases,, an average of 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05618327.

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 2 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in