OncoMatch/Clinical Trials/NCT07368270
Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Is NCT07368270 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Anti-PD1 armored CD19 CAR-T cells for diffuse large b cell lymphoma.
Treatment: Anti-PD1 armored CD19 CAR-T cells — The purpose of this study is to investigate the safety and tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory 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 expression (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — first-line and/or second-line
failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1 x 10^9/L; Absolute lymphocyte count (ALC) ≥ 0.1 x 10^9/L; Platelets ≥ 50 x 10^9/L; Hemoglobin >80g/L
Kidney function
serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m²
Liver function
Serum alanine aminotransferase (ALT) ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg/dL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included.
Cardiac function
Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA)
Subjects with adequate organ functions prior to enrollment, meet the following laboratory values: Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m². Hepatic function: Serum alanine aminotransferase (ALT) ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg/dL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included. Pulmonary reserve: ≤ Grade 1 dyspnea and oxygen saturation >95% on room air. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA). Adequate bone-marrow reserve without blood transfusion as defined by: Absolute neutrophil count (ANC) ≥ 1 x 10^9/L. Absolute lymphocyte count (ALC) ≥ 0.1 x 10^9/L. Platelets ≥ 50 x 10^9/L. Hemoglobin >80g/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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