A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma

• Status: Recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.