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RECRUITING
NCT05641428
PHASE2

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

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2022-10-18

Completion Date

2027-12

Last Updated

2024-09-23

Healthy Volunteers

No

Interventions

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)

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