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OncoMatch/Clinical Trials/NCT05641428

Comparison of Point-of-care Produced CAR T-cell with Commercial CAR T-cells in Patients with R/R LBCL

Is NCT05641428 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including ARI-0001 and Axi-cel for nhl.

Phase 2RecruitingUniversity Medical Center GroningenNCT05641428Data as of May 2026

Treatment: ARI-0001 · Axi-celA phase II, multi-center study to compare the feasibility, and clinical efficacy of local manufacturing of CD19-directed CAR T-cells (ARI-0001 CAR T-cells) with commercial produced CAR T-cells (for example axicabtagene ciloleucel, a CD19 targeting commercially available CAR T-cell) in patients with relapsed or refractory (R/R) DLBCL.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Diffuse Large B-Cell Lymphoma

Performance status

ECOG/WHO 0–2

Prior therapy

Min 2 prior lines

Must have received: systemic therapy

R/R after at least 2 lines of systemic therapy

Lab requirements

Blood counts

ANC <1.0x10^9/L, Platelet count <50x10^9/L, Absolute lymphocyte count <0.1x10^9/L [excluded]

Kidney function

GFR <40 mL/min calculated according to the modified formula of Cockcroft and Gault or by direct urine collection [excluded]

Liver function

total bilirubin, AST and/or ALT >5 x institutional ULN, unless directly attributable to the lymphoma or Gilbert disease [excluded]

Cardiac function

Clinical heart failure with NYHA class ≥2 or LVEF <40% [excluded]

ANC <1.0x10^9/L; Platelet count <50x10^9/L; Absolute lymphocyte count <0.1x10^9/L; Clinical heart failure with New York Heart Association class ≥2 or LVEF <40%; Liver dysfunction as indicated by total bilirubin, AST and/or ALT >5 x institutional ULN, unless directly attributable to the lymphoma or Gilbert disease; GFR <40 mL/min

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

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