OncoMatch/Clinical Trials/NCT04186520
CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies
Is NCT04186520 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including 8/12-Day Production of Car-T Cells and 8/12-Day Production of Cryopreserved Car-T Cells for non hodgkin lymphoma (nhl).
Treatment: 8/12-Day Production of Car-T Cells · 8/12-Day Production of Cryopreserved Car-T Cells · 12-Day Production of Car-T Cells — This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Diffuse Large B-Cell Lymphoma
Primary Central Nervous System Lymphoma
Demographics
Prior therapy
Must have received: anti-CD20 antibody (rituximab)
Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody
Must have received: cytotoxic chemotherapy
at minimum two different chemotherapy regimens appropriate for their disease
Cannot have received: allogeneic CAR T-cell therapy
Prior allogeneic CAR T-cell therapy
Lab requirements
Blood counts
ANC≥1000 with no G-CSF within 72 hours or pegylated G-CSF within 14 days. Platelets≥50,000 with no transfusion within 72 hours.
Kidney function
creatinine clearance >60 ml/min AND serum Cr≤1.5 mg/dL. No IV hydration within 24 hours of eligibility. No dialysis dependent renal failure within three months of planned CAR infusion.
Liver function
AST and ALT <5 x ULN; serum bilirubin and alkaline phosphatase <5 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.
Cardiac function
NYHA class I or II AND LVEF ≥45% (by ECHO or MUGA); pulmonary function: room air oxygen saturation ≥92%
Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <5 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <5 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease. ANC≥1000 with no G-CSF within 72 hours or pegylated G-CSF within 14 days. Platelets≥50,000 with no transfusion within 72 hours. Adequate renal function, defined as creatinine clearance >60 ml/min AND serum Cr≤1.5 mg/dL. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% (by cardiac echocardiogram (ECHO) or multigated acquisition scan (MUGA)) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Medical College of Wisconsin and Froedtert Hospital · Milwaukee, Wisconsin
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04186520 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic CAR T-cell therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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