OncoMatch/Clinical Trials/NCT06875063
GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL
Is NCT06875063 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies GB5005 CART for non-hodgkin lymphoma.
Treatment: GB5005 CART — To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive expression
Positive expression of CD19 in tumor cells confirmed by flow cytometry or pathological histology
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic anti-tumor therapy (rituximab, other CD20 targeted drugs, anthracycline) — including autologous hematopoietic stem cell transplantation
having received at least second-line or above systemic anti-tumor therapy (including autologous hematopoietic stem cell transplantation) containing rituximab (or other CD20 targeted drugs) and anthracycline drugs in the past, and disease progression (PD) or recurrence after the last treatment
Lab requirements
Blood counts
Neutrophils ≥ 1.0 × 10^9/L; Hemoglobin ≥ 70 g/L; Platelets ≥ 50 × 10^9/L
Kidney function
serum creatinine ≤ 2.0x ULN
Liver function
total bilirubin ≤ 1.5x ULN (excluding Gilbert syndrome or hemolysis), ALT and AST ≤ 3.0x ULN
Cardiac function
LVEF ≥ 45% by ECHO or MUGA
Blood routine: Neutrophils ≥ 1.0 × 10^9/L; Hemoglobin ≥ 70 g/L; Platelets ≥ 50 × 10^9/L; Coagulation function: fibrinogen ≥ 1.0 g/L; APTT ≤ ULN+10 s, PT ≤ ULN+3 s; Liver and kidney function indicators: total bilirubin ≤ 1.5x ULN (excluding Gilbert syndrome or hemolysis), ALT and AST ≤ 3.0x ULN, serum creatinine ≤ 2.0x ULN. If the above abnormalities are considered to be caused by tumor infiltration, they can be excluded; Assessment of left ventricular ejection fraction (LVEF) ≥ 45% using echocardiography (ECHO) or radionuclide active vascular scanning (MUGA).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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