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
Inclusion Criteria9
- 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
Exclusion Criteria22
- 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
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05641428
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