Recruiting NCT07661537
A Clinical Study of SHR-3079 in B-cell Non-Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-3079 Injection.
- Who it may be relevant to
- Registry conditions: B-cell Non-Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3079 Injection in Participants With B-Cell Non-Hodgkin Lymphoma
Overview
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.
Interventions
- Drug SHR-3079 Injection
SHR-3079 injection.
Primary outcome measures
- Dose-limiting Toxicity (DLT) [Time frame: 28 days after treatment initiation.]
- Maximum tolerated dose (MTD) [Time frame: Approximately 1 year.]
- Recommended Phase II Dose (RP2D) [Time frame: Approximately 1 year.]
Secondary outcome measures (12)
- Types, incidence and severity of Adverse events (AEs) [Time frame: Approximately 1 year.]
- Serious adverse events (SAEs) [Time frame: Approximately 1 year.]
- Peak concentration (Cmax) [Time frame: Approximately 1 year.]
- Time to peak concentration (Tmax) [Time frame: Approximately 1 year.]
- Area under the curve (AUC0-t, AUC0-inf) [Time frame: Approximately 1 year.]
- Half-life (t1/2) [Time frame: Approximately 1 year.]
- Apparent clearance (CL/F) [Time frame: Approximately 1 year.]
- Apparent volume of distribution (Vz/F) [Time frame: Approximately 1 year.]
- Objective Response Rate (ORR) [Time frame: Approximately 1 year.]
- Best Overall Efficacy(BOR) [Time frame: Approximately 1 year.]
- Time to Response (TTR) [Time frame: Approximately 1 year.]
- Duration of Response (DoR) [Time frame: Approximately 1 year.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Beijing Cancer Hospital — Beijing
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07661537 · SHR-3079-101