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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 (Jun 2026). This Phase 1 trial studies GB5005 CART for non-hodgkin lymphoma.

Phase 1RecruitingThe First Affiliated Hospital of Xiamen UniversityNCT06875063Data as of Jun 2026Location: China

Treatment: GB5005 CARTTo evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).

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Extracted eligibility criteria

Treatments studied

Other

GB5005 CART

Cancer type

Non-Hodgkin Lymphoma

Diffuse Large B-Cell 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)

Demographics

Ages ≤ 70

Prior therapy

Min 2 prior lines

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.

Frequently asked questions

Is NCT06875063 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received systemic anti-tumor therapy.

Does this trial require CD19?

Yes, CD19 positive expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 70 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.

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