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 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT06609304
Eligibility Criteria:
Inclusion Criteria:
1. Understand and voluntarily sign the informed consent form;
2. 18-70 years of age (inclusive);
3. Previously untreated CD19-positive large B-cell lymphoma;
4. Anticipated survival ≥12 weeks;
5. Adequate bone marrow reserve prior to apheresis
6. Appropriate organ function:
7. Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1; 8. Absence of CNS lymphoma;
9\. Negative blood/urine pregnancy test in women of childbearing age.
Exclusion Criteria:
1. History of allergy to any of the components of the cell product;
2. History of stem cell transplantation;
3. History of organ transplantation;
4. Presence of active infections;
5. Current or history of central nervous system disorders;
6. Previous treatment with other modified T-cell therapy;
7. Previous treatment with anti-CD19/CD3 or other anti-CD19 therapies;
8. Malignancies other than those indicated for this trial;
9. History of any prior systemic immune checkpoint therapy;
10. History of short-acting cell growth factors or haematopoietic agonists/stimulants ;
11. History of a live vaccine within 3 months prior to screening;.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06609304
Study Brief:
Protocol Section:
NCT06609304