OncoMatch/Clinical Trials/NCT05370547
Chidamide Bridging for CAR-T Therapy
Is NCT05370547 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Anti-CD19 CAR-T cells and Chidamide for non hodgkin's lymphoma.
Treatment: Chidamide · Fludarabine and cyclophosphamide · Anti-CD19 CAR-T cells — The previous research suggests that the low expression of NOXA protein may be an important biomarker for the treatment of drug resistance of chimeric antigen receptor-T (CAR-T) cells. Up regulating the expression of NOXA through histone deacetylase inhibitor (HDACi) can improve drug resistance and significantly improve the therapeutic effect of CAR-T cells. This study will enroll approximately 120 subjects with recurrent or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL). Those with high expression of NOXA will receive conventional CAR-T treatment (without chidamide bridging), and those with low expression of NOXA will be randomly assigned 1:1 to those without or containing chidamide bridging. The purpose of this study was to evaluate the clinical response and safety of chidamide bridging.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: cd20 monoclonal antibody
Must have received: anthracycline (doxorubicin)
Lab requirements
Blood counts
Neutrophil count (ANC) ≥1.0×10^9/L; Hemoglobin ≥8.0g/dL; Platelet count ≥50×10^9/L
Kidney function
Creatinine clearance ≥40 ml/min using Cockcroft-Gault or GFR ≥40 ml/min/1.73m2
Liver function
Total bilirubin ≤1.5× ULN (<3× ULN for patients with Gilbert syndrome, cholestasis caused by hilar compression adenosis, biliary obstruction caused by liver involvement or lymphoma); ALT/AST ≤2.5× ULN or ≤5× ULN when liver invasion is present
Adequate bone marrow and organ functions (normal values shall not be obtained with growth factors, and hemocytopenia caused by lymphoma invasion of bone marrow is not subject to conditions A, B, and C below) : A. Neutrophil count (ANC) ≥1.0×10^9/L; B. Hemoglobin ≥8.0g/dL; C. Platelet count ≥50×10^9/L; D. Total bilirubin ≤1.5× upper limit of normal value (ULN) (< 3 TIMES ULN for patients with Gilbert syndrome, cholestasis caused by hilar compression adenosis, biliary obstruction caused by liver involvement or lymphoma); E. Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤2.5×ULN or ≤5×ULN when liver invasion is present; F. Creatinine clearance ≥40ml/min using the cockcroft-gault equation or glomerular filtration rate ≥40ml/min/1.73m2 using the modified renal disease diet formula; G. Lipase ≤1.5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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