Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT05113069
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05113069
Study Brief:
Protocol Section:
NCT05113069