OncoMatch/Clinical Trials/NCT05794958
Evaluate Safety of Axicabtagene Ciloleucel Reinfusion (Axi-Cel-2) in Patients With Relapsed and/or Refractory Second Line High-Risk Non-Hodgkin Lymphoma After Standard of Care Axi-Cel
Is NCT05794958 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Axicabtagene Ciloleucel for non-hodgkin lymphoma.
Treatment: Axicabtagene Ciloleucel — This is a phase Ib study to establish safety of Axi-Cel-2 in patients with Large B Cell Lymphoma (LBCL) who are at high risk of relapse.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: CD19 positivity by biopsy (Flow cytometry or immunohistochemistry per the institutional criteria)
If prior CD19 directed therapy, demonstrates CD19 positivity by biopsy (Flow cytometry or immunohistochemistry per the institutional criteria)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: CAR-T cell therapy (axicabtagene ciloleucel) — second line standard of care
subjects receiving second line standard of care Axi-Cel will be enrolled in this study
Cannot have received: CAR-T cell therapy
Exception: Axi-Cel in second line standard of care
Prior treatment with CAR-T or adoptive cell therapy
Cannot have received: adoptive cell therapy
Prior treatment with CAR-T or adoptive cell therapy
Cannot have received: allogeneic transplant
Prior allogeneic transplant
Lab requirements
Blood counts
ANC ≥ 1,000/uL; Platelet count ≥ 75,000/uL
Kidney function
Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL/min
Liver function
Serum ALT or AST ≤ 2.5 x ULN (except in subjects with liver involvement by lymphoma); Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrome.
Cardiac function
Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an Echocardiogram.
Normal Organ and Marrow Function: ANC ≥ 1,000/uL; Platelet count ≥ 75,000/uL; Creatinine clearance ≥ 60 mL/min; Serum ALT or AST ≤ 2.5 x ULN (except in subjects with liver involvement by lymphoma); Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrome; Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an Echocardiogram.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford University · Palo Alto, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify