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

Hengrui Medicine

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: B-cell Non-Hodgkin's Lymphoma

Treatments: Drug: SHR-A1912; R-Chemo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06104553

SHR-A1912-II-201

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

SHR-A1912 combined with R-Chemo (Phase 1b)

Experimental group

Treatment:

Drug: SHR-A1912; R-Chemo

Drug: SHR-A1912; R-Chemo

SHR-A1912 combined with R-Chemo (Phase 2)

Experimental group

Treatment:

Drug: SHR-A1912; R-Chemo

Drug: SHR-A1912; R-Chemo