OncoMatch

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 (Jun 2026). This Phase 2 trial studies multiple treatments including ARI-0001 and Axi-cel for nhl.

Phase 2RecruitingUniversity Medical Center GroningenNCT05641428Data as of Jun 2026Location: Netherlands

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

Treatments studied

Other

ARI-0001Axi-cel

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.

Frequently asked questions

Is NCT05641428 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received systemic therapy.

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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