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

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.

Trial Details

NCT ID
NCT05641428
Phase
PHASE2
Sponsor
University Medical Center Groningen
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • ARI-0001
  • Axi-cel
Locations (sample)
  • Amsterdam, Netherlands|52.37403,4.88969
  • Groningen, Netherlands|53.21917,6.56667
  • Leiden, Netherlands|52.15833,4.49306
  • Maastricht, Netherlands|50.84833,5.68889
  • Nijmegen, Netherlands|51.8425,5.85278

Key Eligibility Criteria

  • Histologically confirmed DLBCL and associated subtypes, defined by WHO 2016 classification: DLBCL not otherwise specified (NOS), High-grade B-cell …
  • 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

For full eligibility, visit ClinicalTrials.gov.

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