OncoMatch/Clinical Trials/NCT04586478
Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Is NCT04586478 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies single dose of CNCT19 for non-hodgkin's lymphoma.
Treatment: single dose of CNCT19 — The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of relapsed or refractory NHL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive (positive)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: CD20-targeted therapy (rituximab)
Received at least Rituximab or other CD20 targeted drugs containing (except CD20 negative tumors) chemotherapy
Must have received: anthracycline
Received at least one chemotherapy regimen containing anthracycline
Must have received: autologous hematopoietic stem cell transplantation
or autologous hematopoietic stem cell transplantation (ASCT)
Cannot have received: CAR-T cell therapy
Patients previously received CAR-T cell therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation
Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT)
Lab requirements
Blood counts
ANC > 1.0×10^9/L; ALC ≥ 0.3×10^9/L; Platelet ≥50×10^9/L
Kidney function
serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)
Liver function
AST ≤ 3 ULN; ALT ≤ 3 ULN; Total serum bilirubin ≤ 2 ULN, unless Gilbert syndrome; Gilbert syndrome: total serum bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN
Cardiac function
LVEF > 45% (ECHO); NYHA Grade I-II only; no uncontrolled hypertension, pulmonary hypertension, unstable angina, recent MI/procedure, significant valvular disease
Adequate bone marrow reserve, defined as: ANC > 1.0×10^9/L; ALC ≥ 0.3×10^9/L; Platelet ≥50×10^9/L; Proper organ function, complying with the following criteria (except hepatic dysfunction due to tumor cell infiltration): AST ≤ 3 ULN; ALT ≤ 3 ULN; Total serum bilirubin ≤ 2 ULN, unless there exists concurrent Gilbert syndrome; patients with Gilbert syndrome, with total serum bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN, may be included; Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); Minimum pulmonary reserve, defined as Grade ≤ 1 dyspnea, and blood oxygen saturation > 91% at non-oxygen inhalation status; INR ≤ 1.5 ULN and aPTT ≤ 1.5 ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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