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OncoMatch/Clinical Trials/NCT05436223

Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma

Is NCT05436223 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Human CD19Targeted T Cells for b-cell non-hodgkin's lymphoma.

Phase 2RecruitingHrain Biotechnology Co., Ltd.NCT05436223Data as of May 2026

Treatment: Human CD19Targeted T CellsA Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for R/R B-NHL. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Performance status

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

Prior therapy

Min 3 prior lines

Must have received: CD20-targeted therapy

the previous use of CD20-targeted drugs ... needed

Must have received: anthracycline

the previous use of ... anthracyclines were needed

Must have received: stem cell transplant

Relapse of B-cell non-Hodgkin lymphoma after stem cell transplantation, regardless of previous treatments

Cannot have received: CAR-T cell therapy

Subjects who have received CAR-T treatment or other gene-modified cell therapy before enrollment

Lab requirements

Blood counts

hemoglobin≥80g/l, neutrophils ≥1.0×10^9/l, platelets ≥75×10^9 / l

Kidney function

serum creatinine≤1.5×uln or creatinine clearance rate≥50ml/min (gockcroftgault formula)

Liver function

total bilirubin≤1.5×uln(gilbert syndrome≤5×uln); alt and ast≤3×uln (ast and alt ≤5×uln in patients with liver metastases)

Cardiac function

cardiac ejection fraction >50%, no clinically significant pericardial effusion detected, no clinically significant pleural effusion detected; baseline blood oxygen saturation>92%

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

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