Efficacy and Safety of Chidamide Combined With PD-1 Inhibitor as Maintenance Therapy Following CAR-T Cell Treatment With TP53-Mutated Large B-Cell Lymphoma (LBCL) (CP-LBCL)

Inclusion Criteria:

1. Histologically or pathologically confirmed relapsed/refractory aggressive large B-cell lymphoma;
2. Documented TP53 mutation confirmed by genetic testing;
3. Age 18-70 years, inclusive; both sexes eligible;
4. Patient has elected and is able to complete a CAR T-cell therapy regimen;
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
6. Life expectancy of at least 3 months;
7. Adequate major organ function (within 7 days prior to initiation of study treatment):

(1) Hepatic function: ALT/AST <3 × the upper limit of normal (ULN), and total bilirubin ≤34.2 μmol/L; (2) Renal function: serum creatinine <220 μmol/L; (3) Pulmonary function: oxygen saturation ≥95% on room air; (4) Cardiac function: left ventricular ejection fraction (LVEF) ≥40%;

8. Patient is able to swallow and take oral medication;

9. Patient has adequate peripheral superficial venous access suitable for intravenous infusion;

10. Voluntary participation in the clinical study; full awareness and understanding of the study; written informed consent provided; willingness and ability to comply with and complete all study procedures.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or patients of childbearing potential who are unwilling to use contraception;
2. Concurrent malignancy of another organ system requiring treatment;
3. Uncontrolled coagulation disorder or active bleeding;
4. Known human immunodeficiency virus (HIV) infection;
5. Currently receiving other antineoplastic therapy (for lymphoma or any other type of tumor);
6. Psychiatric illness, or any other known or suspected inability to fully comply with the study protocol;
7. Inability to swallow capsules, or any disease significantly affecting gastrointestinal function, such as malabsorption syndrome, prior bariatric (weight-reduction) surgery, inflammatory bowel disease, or partial or complete bowel obstruction;
8. Any other concurrent and uncontrolled medical condition that, in the investigator's judgment, would affect the patient's participation in the study.