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New hope for tough lymphoma: experimental drug JS203 enters human testing

NCT ID NCT05618327

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study is testing an experimental drug called JS203 in about 104 people with relapsed or refractory B-cell non-Hodgkin's lymphoma, a type of blood cancer. The main goals are to check the drug's safety, find the right dose, and see if it shows any signs of shrinking tumors. Participants receive the drug through an IV on a schedule that depends on the dose group they are assigned to.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JS203 (an experimental drug for injection)
What this could lead to
If successful, this could lead to a new treatment option for patients with B-cell non-Hodgkin's lymphoma that has not responded to other therapies.
What could go wrong
This is an early Phase 1 trial with only 104 participants, so the drug may not prove effective or safe in larger studies. Side effects are unknown and could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

104 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Understand and voluntarily sign the informed consent form. 2. Age 18 - 75 years (both 18 and 75 years), both sexes 3. Expected survival of ≥ 12 weeks. 4. Eastern Collaborative Oncology Group (ECOG) physical status score: 0 to 1. 5. B-cell non-Hodgkin's lymphoma expressing CD20 antigen clearly diagnosed by pathology 6. 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. Exclusion Criteria: 1. history of severe allergy or anaphylactic reaction to monoclonal antibody therapy (or recombinant antibody-associated fusion protein). 2. previous treatment with CD20-CD3 bispecific antibodies. 3. 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. 4. 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). 5. receive autologous hematopoietic stem cell transplantation within 100 days prior to the first dose 6. 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 7. 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. 8. 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%. 9. 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. 10. persons with uncontrollable psychiatric disorders 11. patients with a history of drug abuse or alcohol abuse 12. 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.