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 (Jul 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
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 expression (testing required; no eligibility threshold specified)
The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available
Prior therapy
Must have received: anthracycline-containing regimen
Subjects must have previously been treated with a regimen that includes an anthracycline
Must have received: anti-CD20 monoclonal antibody
Subjects must have previously been treated with a regimen that includes ... an anti-CD20 monoclonal antibody
Cannot have received: CD19 CAR T cell therapy
Recipient of CD19 CAR T cell therapy outside of this protocol
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >= 1000 (ANC >= 500 if documented bone marrow involvement by disease); Platelets >= 100/mm^3; Hemoglobin > 8 g/dL
Kidney function
Creatinine clearance >= 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
Left ventricular ejection fraction >= 45% as determined by echocardiogram and no clinically significant ECG findings
Absolute neutrophil count (ANC) >= 1000; Platelets >= 100/mm^3; Hemoglobin > 8 g/dL; Creatinine clearance >= 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
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05052528 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CD19 CAR T cell therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
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