B-cell Non-Hodgkin's Lymphoma
Conditions
Brief summary
This study aims to evaluate the safety, PK and preliminary anti-tumour activity of SHR-A1912 combined with other therapies in patients with B-cell non-Hodgkin 's lymphoma.
Interventions
DRUGSHR-A1912; R-Chemo
SHR-A1912 combined with R-Chemo: SHR-A1912 + R-Chemo (Rituximab + Chemotherapy) (Phase 1b)
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An open, multicenter, dose-finding and dose expansion investigational Phase Ib/II clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to18 years old; 2. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1; 3. Life expectancy \>3 months; 4. Histologically confirmed B-cell B-cell non-Hodgkin's lymphoma; 5. Previous systematic anti-tumor therapy should meet the following requirements: 1) Relapsed and/or refractory disease after at least one (≥ 1) line of prior systemic therapy (relapsed/refractory cohort); 2) Previously untreated (naïve cohort). 6. At least one measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or one measurable extra nodal lesion, defined as \> 1.0 cm in its longest diameter.
Exclusion criteria
1. Received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received Car-T cell therapy within 12 weeks before the first study treatment; 2. History of recent major surgery or severe trauma within 4 weeks before the first study treatment; 3. Received anti-tumour treatment within 2 weeks before the first study treatment; 4. Central nervous system (CNS) infiltration; 5. Active infection with HBV or HCV; 6. History of immunodeficiency, including HIV serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis; 7. Active infection or unexplained fever\>38.5℃; 8. History of severe cardiovascular disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1b: RP2D (Recommended Phase II Dose) of SHR-A1912 combined with immunochemotherapy | The RP2D for Phase 2 will be selected at the end of Phase 1b, approximately 12 months |
| Phase 1b: Incidence and severity of AE | Up to follow-up period, approximately 24 months] |
| Phase 2: Objective response rate | assessed up to approximately 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1b: Progression-free survival (PFS) | assessed up to approximately 24 months |
| Phase 1b: Toxin binding antibody to SHR-A1912 | Up to follow-up period, approximately 24 months |
| Phase 1b: Total antibody to SHR-A1912 | Up to follow-up period, approximately 24 months |
| Phase 1b: Concentration of free toxin | Up to follow-up period, approximately 24 months |
| Phase 1b: Anti-drug antibodies (ADA) to SHR-A1912 | Up to follow-up period, approximately 24 months |
| Phase 2: Complete response rate (CRR) | assessed up to approximately 24 months |
| Phase 1b: Objective response rate | assessed up to approximately 24 months |
| Phase 2: Progression-free survival (PFS) | assessed up to approximately 24 months |
| Phase 2: Incidence and severity of AE | Up to follow-up period, approximately 24 months |
| Phase 2: Toxin binding antibody to SHR-A1912 | Up to follow-up period, approximately 24 months |
| Phase 2: Total antibody to SHR-A1912 | Up to follow-up period, approximately 24 months |
| Phase 2: Concentration of free toxin | Up to follow-up period, approximately 24 months |
| Phase 2: Anti-drug antibodies (ADA) to SHR-A1912 | Up to follow-up period, approximately 24 months |
| Phase 2: Duration of remission (DoR) | assessed up to approximately 24 months |
| Phase 1b: Complete response rate (CRR) | assessed up to approximately 24 months |
| Phase 1b: Duration of remission (DoR) | assessed up to approximately 24 months |
Countries
China
Contacts
Primary ContactZhenyu Xiao, Medical Director
Outcome results
None listed