Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL - Diffuse Large B Cell Lymphoma | Interdigitating Dendritic Cell Sarcoma | PROBABILISTIC | 0.70 |
| NHL | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARI-0001 | Drug | — | UNRESOLVED |
| Axi-cel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (ARI-0001)
- description
- Infusion with Point of Care CAR T-cells
- interventionNames
- Drug: ARI-0001
- type
- ACTIVE_COMPARATOR
- label
- Arm B (Axi-cel)
- description
- Infusion with Standard of Care CAR T-cells
- interventionNames
- Drug: Axi-cel
Primary outcomes (1)
- measure
- Progression-free survival (PFS) from date of IMP infusion (if applicable)
- timeFrame
- Approximately up to 60 months following first patient IMP infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
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