RecruitingPhase 1Phase 2NCT06104553
A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma
A Phase Ib/II Study of SHR-A1912 Combined With Other Therapies in Patients With B-cell Non-Hodgkin 's Lymphoma
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Enrollment
132 participants
Start Date
Nov 17, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- Age greater than or equal to18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
- Life expectancy \>3 months;
- Histologically confirmed B-cell B-cell non-Hodgkin's lymphoma;
- 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).
- 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 Criteria8
- 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;
- History of recent major surgery or severe trauma within 4 weeks before the first study treatment;
- Received anti-tumour treatment within 2 weeks before the first study treatment;
- Central nervous system (CNS) infiltration;
- Active infection with HBV or HCV;
- History of immunodeficiency, including HIV serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis;
- Active infection or unexplained fever\>38.5℃;
- History of severe cardiovascular disease.
Interventions
DRUGSHR-A1912; R-Chemo
SHR-A1912 combined with R-Chemo: SHR-A1912 + R-Chemo (Rituximab + Chemotherapy) (Phase 1b)
DRUGSHR-A1912; R-Chemo
SHR-A1912 combined with R-Chemo: SHR-A1912 (RP2D) + R-Chemo (Rituximab + Chemotherapy) (Phase 2)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06104553
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