Comparison of Point-of-care Produced CAR T-cell with Commercial CAR T-cells in Patients with R/R LBCL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Absolute neutrophil count (ANC) <1.0x10^9/L
Platelet count <50x10^9/L
Absolute lymphocyte count <0.1x10^9/L
Primary CNS lymphoma
Trial design
Treatments tested in this trial
- ARI-0001
- Axi-cel
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Medical Center Groningen
Lead sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborator
Source ClinicalTrials.gov