Study of LP002 for the Treatment of Patients With Relapsed or Refractory Primary Mediastinal Larg… (NCT04600947) | Clinical Trial Compass
UnknownPhase 2
Study of LP002 for the Treatment of Patients With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma
China69 participantsStarted 2020-12-30
Plain-language summary
LP002 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. In this study, the efficacy and safety of LP002 for the treatment of relapsed or refractory primary mediastinal large B-cell lymphoma will be evaluated.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be willing and able to provide written informed consent for the trial;
✓. Age ≥ 18 years old, male or female;
✓. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score;
✓. Life expectancy ≥ 3 months;
✓. Subjects must have histopathological diagnosis of primary mediastinal large B-cell lymphoma (PMBCL), according to the WHO classification of lymphoma (revised in 2017) (diagnosis is confirmed by the central pathological review), and meet the following criteria:
✓. Recurrence after autologous hematopoietic stem cell transplantation (ASCT), or complete remission (CR) or partial remission (PR) is not achieved within 60 days after ASCT. If patients with relapse or refractory ASCT receive other interventions, they must be relapsed or refractory after the last systemic treatment;
✓. Patients who are not suitable for ASCT must be second-line or above chemotherapy invalid or recurring; local radiotherapy alone is not considered as first-line treatment;
✓. Need to be treated with rituximab, or cannot be treated with rituximab for any reason;
Exclusion criteria
✕. Suffered from other malignant tumors in the past 3 years (except skin basal cell carcinoma, squamous cell carcinoma, and cervical carcinoma in situ that have been effectively controlled);
✕. Currently participating in interventional clinical research treatment, or receiving other experimental drugs or using experimental device treatment within 4 weeks before the first administration;
✕. Received systemic systemic chemotherapy or targeted drug therapy within 4 weeks or 5 half-lives before the first administration;
✕. The study drug has received anti-tumor indications Chinese herbal medicine, or immunomodulatory drugs (including thymosin, interferon, interleukin, etc., except for local use to control pleural effusion or pericardial effusion) within 2 weeks before the first administration Systemic systemic therapy;
✕. Received monoclonal antibody drug treatment within 4 weeks before the first administration;
✕. Received radical or palliative radiotherapy within 4 weeks before the first administration;
✕. Received autologous stem cell transplantation within 8 weeks before the first administration;
✕. Prior to the first administration of the study drug, there was a grade \> 1 toxicity (excluding hair loss, non-clinical) caused by previous anti-tumor treatments;