SHR-3079 in B-cell non-Hodgkin lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial is designed to evaluate the safety and tolerability of SHR-3079 given by injection in adults with B-cell non-Hodgkin lymphoma who have received prior therapy. The study aims to identify the dose-limiting toxicity, determine the maximum tolerated dose, and establish the recommended dose for a subsequent trial. Efficacy is explored preliminarily in this patient population. Participants must have measurable disease, adequate organ function, and an ECOG performance status of 0-1. The trial is conducted at two sites in China and includes strict eligibility criteria and follow-up requirements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥ 18 years old;
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months;
3. Histologically confirmed B-NHL;
4. Participant population: Have received ≥ 1 line of standard anti-tumor treatment, and have not achieved response after the latest treatment or have progressive disease after the treatment;
5. Have measurable lesions;
6. Have adequate organ function;
7. Male participants and female participants of childbearing potential must use adequate and effective contraceptive measures during the study and within 3 months after the last drug administration of SHR-3079. Female participants must not be lactating and must have a negative blood HCG test result within 7 days before the first dose;
8. Voluntarily sign the ICF, have good compliance, and be willing to cooperate with follow-up.

Exclusion Criteria:

1. Central nervous system (CNS) infiltration;
2. Prior chemotherapy or other anti-lymphoma agents administered within 4 weeks before the first dose of study treatment;
3. Major surgery within 4 weeks before signing the ICF, or plan to undergo major surgery during the study period;
4. Receipt of CAR-T therapy or autologous stem cell transplant within 12 weeks prior to enrollment;
5. Receipt of allogeneic hematopoietic stem cell transplantation;
6. Prior solid organ transplantation;
7. Positive hepatitis C virus (HCV) antibody with HCV-RNA copy number above the upper limit of normal of the study site; positive hepatitis B surface antigen \[HBsAg\] and/or positive hepatitis B core antibody (HBcAb) with HBV DNA copy number above the upper limit of normal of the study site;
8. Presence of severe disorders involving major organ systems;
9. Pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
10. Pregnant, lactating women, or women planning to become pregnant;
11. Have other serious physical or mental illness, laboratory test abnormalities, or other factors that may increase the risk of study participation or interfere with the study results.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Wei Ji, M.M
• Email: wei.ji.wj10@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.