A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma

SHR-A1912-I-101

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.

2021-12-22

2024-03-31

2025-03-30

Early phase I

170

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single arm for SHR-A1912', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 170, 'type': 'ESTIMATED'}}

2023-12-06