Status:
RECRUITING
A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma
Lead Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions:
B-cell Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06104553
Start Date
November 17 2023
End Date
June 1 2026
Last Update
December 27 2023
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142