OncoMatch/Clinical Trials/NCT04545762
Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma
Is NCT04545762 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including anti-CD19 CAR-T cells and Fludarabine for refractory non-hodgkin lymphoma.
Treatment: Fludarabine · Cyclophosphamide · anti-CD19 CAR-T cells — This study will assess safety and feasibility of infusing genetically modified autologous T cells transduced to express a chimeric antigen receptor targeting the B cell surface antigen Cluster of Differentiation 19 (CD19).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: CD19 positive
CD19-positive by either immunohistochemistry or flow cytometry analysis on any biopsy. If prior anti-CD19 therapy has been administered, CD19-positivity has to be re-established on the most recent biopsy.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: multiagent chemoimmunotherapy (anti-CD20 antibody, anthracycline) — Burkitt Lymphoma
Participants with Burkitt lymphoma must have relapsed or failed to respond to at least 1 prior line of multiagent chemoimmunotherapy with prior exposure to both an anti-CD20 antibody agent and an anthracycline.
Must have received: multi-agent chemoimmunotherapy (anti-CD20 antibody, alkylating agent) — Marginal Zone Lymphoma or Lymphoplasmacytic Lymphoma/Waldenström Macroglobulinemia
Participants with indolent lymphomas (nodal or extranodal marginal zone lymphoma, and lymphoplasmacytic lymphoma) must have relapsed after or have been refractory to ≥ 2 prior lines of multi-agent chemoimmunotherapy including prior exposure to an anti-CD20 antibody and an alkylating agent.
Cannot have received: autologous transplant
Exception: within 6 weeks of planned CAR-T cell infusion
Autologous transplant within 6 weeks of planned CAR-T cell infusion.
Cannot have received: CAR-T cell therapy targeting CD19
Exception: outside of this protocol
Recipient of prior CAR-T cell therapy targeting CD19 outside of this protocol.
Lab requirements
Blood counts
Hemoglobin >8 gm/dl (transfusions allowed); Platelets >50,000/uL (transfusions allowed); Absolute Neutrophil Count (ANC) > 500/uL
Kidney function
Serum Creatinine < 2 x the institutional ULN
Liver function
ALT/AST < 3 x institutional ULN and Total bilirubin < 1.5 mg/dl x institutional ULN, except with Gilbert's syndrome
Cardiac function
LVEF > 40% as assessed by echocardiogram or MUGA within 3 months of screening
Adequate organ function, defined as: Adequate bone marrow function for apheresis and lymphodepleting chemotherapy; Hemoglobin >8 gm/dl (transfusions allowed); Platelets >50,000/uL (transfusions allowed); Absolute Neutrophil Count (ANC) > 500/uL; ALT/AST < 3 x institutional ULN and Total bilirubin < 1.5 mg/dl x institutional ULN, except with Gilbert's syndrome; Serum Creatinine < 2 x the institutional ULN; Adequate cardiac function, defined as LVEF > 40% as assessed by echocardiogram or MUGA within 3 months of screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco · San Francisco, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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