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

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

Recruiting
18 years and older
All
Phase 1/2

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Overview

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.

Eligibility

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.

Study details
    B-cell Non-Hodgkin's Lymphoma

NCT06104553

Shanghai Hengrui Pharmaceutical Co., Ltd.

28 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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