RecruitingPhase 2NCT05641428

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


Sponsor

University Medical Center Groningen

Enrollment

300 participants

Start Date

Oct 18, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of CAR T-cell therapy for people with relapsed or treatment-resistant large B-cell lymphoma: a commercial CAR T product versus one made on-site at the point of care. Both are engineered immune cell therapies designed to attack lymphoma cells. **You may be eligible if...** - You have been diagnosed with diffuse large B-cell lymphoma (DLBCL) or a related subtype - Your lymphoma has come back or stopped responding to at least 2 previous treatments - You are 18 or older and in acceptable health (ECOG 0–2) - Your life expectancy is more than 3 months beyond your lymphoma - You are willing to use contraception if of childbearing potential **You may NOT be eligible if...** - You have untreated central nervous system involvement causing symptoms - Your organ function is too poor to tolerate the therapy - You have an active serious infection - You do not meet the performance status requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGARI-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).

DRUGAxi-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)

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

View Full Details on ClinicalTrials.gov

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NCT05641428


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