OncoMatch/Clinical Trials/NCT06478381

L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma

Is NCT06478381 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies L218CAR19 for relapsed/refractory b-cell lymphomas.

Phase 1RecruitingHenan Cancer HospitalNCT06478381Data as of May 2026

Treatment: L218CAR19 — L218CAR19 is a kind of chimeric antigen receptor T-cell immunotherapy targeting CD19 on B cells. The goal of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of L218CAR19 in patients with B-cell lymphomas who have received at least two lines of systemic treatment.

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Extracted eligibility criteria

Biomarker criteria

Required: CD19 positive

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 2 prior lines

Cannot have received: CAR-T cell therapy

Patients with prior CAR-T therapy

Cannot have received: allogeneic stem cell transplant

History of allogeneic stem cell transplantation

Cannot have received: autologous stem cell transplant

Exception: within 6 months of screening

History of autogeneic stem cell transplantation within 6 months of screening

Lab requirements

Blood counts

Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement

Kidney function

Serum creatinine ≤ 1.5 x ULN

Liver function

Serum bilirubin ≤ 1.5 x ULN, or ≤3 x ULN if elevation is due to hepatic involvement by lymphoma; AST and/or ALT ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma

Cardiac function

left ventricular ejection fraction (LVEF) ≥ 50%

Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN), or ≤3 x ULN if elevation is due to hepatic involvement by lymphoma; Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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