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 (Jun 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
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive (positive)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT04586478 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, allogeneic hematopoietic stem cell transplantation disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 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.
Check if I qualifyRelated pages