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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Phase II Non-inferiority Study Comparing Point-of-care Produced CAR T-cell to Commercial CAR T-cells in Patients with Relapsed/refractory Non-Hodgkin Lymphoma

Comparison of Point-of-care Produced CAR T-cell with Commercial CAR T-cells in Patients with R/R LBCL (NCT05641428) is a Phase 2 interventional studying NHL and DLBCL - Diffuse Large B Cell Lymphoma, sponsored by University Medical Center Groningen. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

A 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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against NHL and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 300 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - diagnosed by tissue sample (biopsy-confirmed) DLBCL and associated subtypes, defined by WHO 2016 classification: DLBCL not otherwise specified (NOS), High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and FL3B, T-cell/histocyte rich B-cell lymphoma, Primary mediastinal B-cell lymphoma, transformed lymphoma (transformed follicular) and R/R after at least 2 lines of systemic therapy - Age ≥ 18 - Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0-2 - Secondary central nervous system (CNS) involvement is allowed however, then he/she must have \* No signs or symptoms of CNS involvement that would hamper adequate ICANS assessment - Estimated life expectancy of \>3 months other than primary disease - Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen - Signed and dated willing to sign a consent form before conduct of any trial-specific procedure - Patient is capable of giving willing to sign a consent form Who Should NOT Join This Trial: - Absolute neutrophil count (ANC) \<1.0x10\^9/L - Platelet count \<50x10\^9/L - Absolute lymphocyte count \<0.1x10\^9/L - Primary CNS lymphoma - Known history of infection with hepatitis C or B virus unless treated and confirmed to be polymerase chain reaction (PCR) negative - Active HIV infection with detectable viral load or CD4 T-cell count below 0.20x10\^9/L - Known history or presence of seizure activities or on active anti- seizure medications within the previous 12 months - Known history of CVA within prior 12 months - Unstable neurological deficits - Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Histologically confirmed DLBCL and associated subtypes, defined by WHO 2016 classification: DLBCL not otherwise specified (NOS), High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and FL3B, T-cell/histocyte rich B-cell lymphoma, Primary mediastinal B-cell lymphoma, transformed lymphoma (transformed follicular) and R/R after at least 2 lines of systemic therapy * Age ≥ 18 * Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0-2 * Secondary central nervous system (CNS) involvement is allowed however, then he/she must have \* No signs or symptoms of CNS involvement that would hamper adequate ICANS assessment * Estimated life expectancy of \>3 months other than primary disease * Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen * Signed and dated informed consent before conduct of any trial-specific procedure * Patient is capable of giving informed consent Exclusion Criteria: * Absolute neutrophil count (ANC) \<1.0x10\^9/L * Platelet count \<50x10\^9/L * Absolute lymphocyte count \<0.1x10\^9/L * Primary CNS lymphoma * Known history of infection with hepatitis C or B virus unless treated and confirmed to be polymerase chain reaction (PCR) negative * Active HIV infection with detectable viral load or CD4 T-cell count below 0.20x10\^9/L * Known history or presence of seizure activities or on active anti- seizure medications within the previous 12 months * Known history of CVA within prior 12 months * Unstable neurological deficits * Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease * Active systemic autoimmune disease for which immunosupressive therapy is required * Presence of CNS disease that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity, baseline dementia that would interfere with therapy or monitoring, determined using mini-mental status exam at baseline * Active systemic fungal, viral or bacterial infection * Clinical heart failure with New York Heart Association class ≥2 (appendix F) or Left Ventricular Ejection Fraction (LVEF) \<40% * Resting oxygen saturation \<92% on room air * 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 calculated according to the modified formula of Cockcroft and Gault or by direct urine collection * Pregnant or breast-feeding woman * Active other malignancy requiring treatment * Medical condition requiring prolonged use of systemic immunosuppressives with exception of prednisolone \<10 mg/day * History of severe immediate hypersensitivity reaction against any drug or its Ingredients/impurities that is scheduled to be given during trial participation e.g. as part of the mandatory lymphodepletion protocol, premedication for infusion, or rescue medication/salvage therapies for treatment related toxicities * Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Treatments Being Tested

DRUG

ARI-0001

Infusion with a single target dose of 2.0 x 10\^6 Point of Care CAR T-cells/kg BW (range 1 -2.0x 10\^6 CAR T-cells /kg BW).

DRUG

Axi-cel

Infusion with a single target dose of 2.0 x 10\^6 Standard of Care CAR T-cells/kg BW (range 1 -2.0x 10\^6 CAR T-cells /kg BW).

Locations (7)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

NL-Amsterdam-AMC
Amsterdam, Netherlands
NL-Groningen-UMCG
Groningen, Netherlands
NL-Leiden-LUMC
Leiden, Netherlands
NL-Maastricht-MUMC
Maastricht, Netherlands
NL-Nijmegen-RADBOUDUMC
Nijmegen, Netherlands
NL-Rotterdam-ERASMUSMC
Rotterdam, Netherlands
NL-Utrecht-UMCUTRECHT
Utrecht, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05641428), the sponsor (University Medical Center Groningen), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05641428 clinical trial studying?

A 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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05641428?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05641428?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05641428. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05641428. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.