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Recruiting Phase 1

A Clinical Study of SHR-3079 in B-cell Non-Hodgkin Lymphoma

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About this study

The study is being conducted to evaluate the safety and tolerability of SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin lymphoma.

Condition
B-cell Non-Hodgkin Lymphoma
Tested
SHR-3079 Injection
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 11

  • Minimum age: 18 years
  • Study condition: B-cell Non-Hodgkin Lymphoma
  • Aged ≥ 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months;
  • Histologically confirmed B-NHL;
  • 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;
  • Have measurable lesions;
  • Have adequate organ function;
  • 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;
  • Voluntarily sign the ICF, have good compliance, and be willing to cooperate with follow-up.

Exclusion 11

  • Central nervous system (CNS) infiltration;
  • Prior chemotherapy or other anti-lymphoma agents administered within 4 weeks before the first dose of study treatment;
  • Major surgery within 4 weeks before signing the ICF, or plan to undergo major surgery during the study period;
  • Receipt of CAR-T therapy or autologous stem cell transplant within 12 weeks prior to enrollment;
  • Receipt of allogeneic hematopoietic stem cell transplantation;
  • Prior solid organ transplantation;
  • 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;
  • Presence of severe disorders involving major organ systems;
  • Pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
  • Pregnant, lactating women, or women planning to become pregnant;
  • 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

2 sites, 2 recruiting

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Recruiting

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.