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OncoMatch/Clinical Trials/NCT04186520

CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies

Is NCT04186520 recruiting? Yes, currently enrolling (May 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).

Phase 1/2RecruitingMedical College of WisconsinNCT04186520Data as of May 2026

Treatment: 8/12-Day Production of Car-T Cells · 8/12-Day Production of Cryopreserved Car-T Cells · 12-Day Production of Car-T CellsThis 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.

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Extracted eligibility criteria

Cancer type

Hodgkin Lymphoma

Non-Hodgkin Lymphoma

Chronic Lymphocytic Leukemia

Diffuse Large B-Cell Lymphoma

Prior therapy

Min 2 prior lines

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

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