A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas

Launched by SHANGHAI HENGRUI PHARMACEUTICAL CO., LTD. · Nov 5, 2021

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age greater than or equal to18 years old, male or female;
• • 2. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
• • 3. Life expectancy \>12 weeks;
• • 4. Histologically or cytologically confirmed B cell lymphoma;
• • 5. Relapsed and/or refractory disease after at least 1 prior treatment regimen;
• • 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 (no need for dose escalation stage).
• 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.