OncoMatch/Clinical Trials/NCT05052528
Fludarabine and Cyclophosphamide With or Without Rituximab Before CD19 Chimeric Antigen Receptor T Cells for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Is NCT05052528 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Chimeric Antigen Receptor T-Cell Therapy and Rituximab for recurrent diffuse large b-cell lymphoma.
Treatment: Chimeric Antigen Receptor T-Cell Therapy · Cyclophosphamide · Fludarabine Phosphate · Rituximab — This phase I trial evaluates the best dose, possible benefits and/or side effects of fludarabine and cyclophosphamide with or without rituximab before CD19 chimeric antigen receptor T cells in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or has not responded to previous treatment (refractory). T-cells are a normal part of the immune system. To make the T-cell medication, T-cells are taken from the blood and altered in a laboratory. They are then returned to the body. The altered T-cells will latch on to a specific part of the cancer cells and hopefully kill them. Once the T-cells have been altered in the laboratory, they are called "CAR T-cells." CAR is short for "chimeric antigen receptors." These are structures on the surface of cells that allow the altered T-Cells to find and destroy the cancer cells. Another part of the T-Cell medication is called "CD19." This part is called a "biomarker." Biomarkers help doctors determine whether a cancer is getting worse and whether medications are working to stop it. The chemotherapy drugs that are given before the T-Cell therapy are cyclophosphamide, fludarabine and rituximab. Rituximab is an immunotherapy drug. These chemotherapy drugs will reduce the number of normal (unaltered) T-Cells in the body to make room for the altered T-cells to kill the cancer cells. Giving fludarabine and cyclophosphamide with or without rituximab before CD19 CAR T cell therapy may help improve response to CD19 CAR T cell therapy in patients with diffuse large B-cell lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive (positive)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline
Must have received: anti-cd20 monoclonal antibody
Cannot have received: cd19 car t cell therapy
Lab requirements
Blood counts
ANC >= 1000; Platelets >= 100/mm^3; Hemoglobin > 8 g/dL; ANC >= 500 is acceptable if documented bone marrow involvement by disease
Kidney function
Creatinine clearance (estimated by Cockcroft Gault) or using 24 hour urine collection >= 50 cc/min
Liver function
Total bilirubin <= 2 mg/dL except in subjects with Gilbert's Syndrome in whom total bilirubin must be <= 3.0; ALT/AST <= 3 x ULN or <= 5 x ULN if documented liver involvement by disease
Cardiac function
Cardiac left ventricular ejection fraction >= 45% as determined by an echocardiogram and no clinically significant ECG findings
Absolute neutrophil count (ANC) >= 1000; Platelets >= 100/mm^3; Hemoglobin > 8 g/dL; ANC >= 500 is acceptable if documented bone marrow involvement by disease; Creatinine clearance (estimated by Cockcroft Gault) or using 24 hour (hr) urine collection >= 50 cc/min; Total bilirubin <= 2 mg/dL except in subjects with Gilbert's Syndrome in whom total bilirubin must be <= 3.0; ALT/AST <= 3 x ULN or <= 5 x ULN if documented liver involvement by disease; Cardiac left ventricular ejection fraction >= 45% as determined by an echocardiogram and no clinically significant electrocardiogram (ECG) findings; Baseline oxygen saturation > 92% on room air
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Davis Comprehensive Cancer Center · Sacramento, California
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