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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT06517004
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18
2. Voluntarily willing to participate in the study and sign the written informed consent form
3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) with immunohistochemistry (IHC) CD20-positive
4. Patients must be priorly treated by Anthracyclines and anti-CD20-targeted regimens, and must be refractory or relapsed to at least ≥2 treatment lines of standard of care or autologous hematopoietic stem-cell transplantation (HSCT)
5. At least one measurable lesion by CT or PET per Lugano criteria
6. Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1
7. Adequate organ functions
8. Adequate venous access for apheresis
9. Women of childbearing potential must agree to use an effective and reliable contraceptive method till 1-year post-infusion
10. Male patients who have not undergone vasectomy and have sexual activity with women of childbearing potential must agree to the use of a barrier contraceptive till 1-year post-infusion
Exclusion Criteria:
1. Primary central nervous system lymphoma
2. Another primary malignancy within 2 years
3. Active infections of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis
4. With severe active deep venous thrombosis or pulmonary embolism within 3 months
5. Treated with anti-coagulations (except for prophylaxis use) due to severe active deep venous thrombosis or pulmonary embolism within 3 months
6. Uncontrolled or active infection
7. Acute or chronic graft-versus-host disease (GvHD)
8. With severe cardiovascular diseases within 6 months
9. With severe clinically-significant central nervous system disorders within 6 months
10. Pregnant or lactating women
11. Not satisfying pre-defined wash-out period for apheresis
12. Unable or unwilling to comply with the study protocol, judged by the investigator, or other situations implying that the subject might not be appropriate to participate in the study
13. Previously treated with any genetically engineered modified T-cell therapy nor other cell-gene therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06517004
Study Brief:
Protocol Section:
NCT06517004