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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT07368270 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy.
Does this trial require CD19?
Yes, CD19 positive 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