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

Hengrui Medicine

Status and phase: Invitation-only; Phase 1

Conditions: B Cell Lymphoma

Treatments: Drug: SHR-A1912

Study type: Interventional

Funder types: Industry

Identifiers

NCT05113069

SHR-A1912-I-101

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

Treatment group

Experimental group

Description:

SHR-A1912

Treatment:

Drug: SHR-A1912