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

Recruiting now · Phase 2

Conditions studied: NHL, DLBCL - Diffuse Large B Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT05641428

Run by

University Medical Center Groningen

People needed

300

Starts

2022-10-18

Expected to finish

2027-12-01

Last updated by the study team

2024-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NL-Amsterdam-AMC — Amsterdam, Netherlands (enrolling)
• NL-Groningen-UMCG — Groningen, Netherlands (enrolling)
• NL-Leiden-LUMC — Leiden, Netherlands (enrolling)
• NL-Maastricht-MUMC — Maastricht, Netherlands (enrolling)
• NL-Nijmegen-RADBOUDUMC — Nijmegen, Netherlands (enrolling)
• NL-Rotterdam-ERASMUSMC — Rotterdam, Netherlands (enrolling)
• NL-Utrecht-UMCUTRECHT — Utrecht, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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