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:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT05800067
Eligibility Criteria:
Inclusion Criteria:
1. Informed Consent Form (ICF);
2. Adults with diagnosed relapsed or refractory Large B-cell lymphoma who have completed initial treatment with Axi-cel;
3. non-CR or relapsed after the initial Axi-cel infusion;
4. CD19 status by lymphoma lesion biopsy is at the discretion of investigators.
5. Antidrug antibodies (ADA) of Axi-cel should be performed prior to retreatment. 6) Lymphodepleting chemotherapy (fludarabine and cyclophosphamid) related toxicities were ≤ grade 1 or at the base line of Axi-cel initial treatment.
8）No serious adverse events occurred during the initial Axi-cel treatment or the adverse events in the first treatment period have recovered.
Exclusion Criteria:
1. Patients with hypersensitivity to any active ingredient or excipients (dimethyl sulfoxide, compound electrolyte injection, human albumin);
2. Uncontrolled systemic fungal, bacterial, viral, or other infections
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05800067
Study Brief:
Protocol Section:
NCT05800067