B-cell Non-Hodgkin Lymphoma
Conditions
Brief summary
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
DRUGSHR-3079 Injection
SHR-3079 injection.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SHR-3079 Monotherapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting Toxicity (DLT) | 28 days after treatment initiation. |
| Maximum tolerated dose (MTD) | Approximately 1 year. |
| Recommended Phase II Dose (RP2D) | Approximately 1 year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Types, incidence and severity of Adverse events (AEs) | Approximately 1 year. | Safety endpoints. |
| Serious adverse events (SAEs) | Approximately 1 year. | Safety endpoints. |
| Peak concentration (Cmax) | Approximately 1 year. | Pharmacokinetics (PK) Parameters. |
| Time to peak concentration (Tmax) | Approximately 1 year. | Pharmacokinetics (PK) Parameters. |
| Area under the curve (AUC0-t, AUC0-inf) | Approximately 1 year. | Pharmacokinetics (PK) Parameters. |
| Half-life (t1/2) | Approximately 1 year. | Pharmacokinetics (PK) Parameters. |
| Apparent clearance (CL/F) | Approximately 1 year. | Pharmacokinetics (PK) Parameters. |
| Apparent volume of distribution (Vz/F) | Approximately 1 year. | Pharmacokinetics (PK) Parameters. |
| Objective Response Rate (ORR) | Approximately 1 year. | Preliminary efficacy endpoints. |
| Best Overall Efficacy(BOR) | Approximately 1 year. | Preliminary efficacy endpoints. |
| Time to Response (TTR) | Approximately 1 year. | Preliminary efficacy endpoints. |
| Duration of Response (DoR) | Approximately 1 year. | Preliminary efficacy endpoints. |
| Progression-Free Survival (PFS) | Approximately 1 year. | Preliminary efficacy endpoints. |
| Overall Survival (OS) | Approximately 1 year. | Preliminary efficacy endpoints. |
Countries
China
Contacts
CONTACTWei Ji, M.M
Outcome results
None listed