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

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety and tolerability of SHR-A1912 in patients with B cell lymphoma, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1912.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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 or Car-T cell therapy;

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.