NCT05641428 Comparison of Point-of-care Produced CAR T-cell with Commercial CAR T-cells in Patients with R/R LBCL
| NCT ID | NCT05641428 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Medical Center Groningen |
| Condition | NHL |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-10-18 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2022-10-18 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
T. (Tom) van Meerten
PRINCIPAL INVESTIGATOR
UMCG / HOVON
Frequently Asked Questions
Who can join the NCT05641428 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NHL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05641428 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05641428 currently recruiting?
Yes, NCT05641428 is actively recruiting participants. Contact the research team at hdc@erasmusmc.nl for enrollment information.
Where is the NCT05641428 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Groningen, Netherlands, Leiden, Netherlands, Maastricht, Netherlands and 3 additional locations.
Who is sponsoring the NCT05641428 clinical trial?
NCT05641428 is sponsored by University Medical Center Groningen. The principal investigator is T. (Tom) van Meerten at UMCG / HOVON. The trial plans to enroll 300 participants.