2024-511979-15-00招募中2 期
HOVON 161: 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
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 7
- 主要终点
- PFS from date of IMP infusion (if applicable).
研究概览
简要总结
To compare progression free survival (PFS) of patients randomized to investigational point-of-care (PoC) ARI-0001 CAR T-cells versus PFS of patients randomized to commercial standard-of-care (SoC) (axicabtagene ciloleucel (Axi-cel, Yescarta)) CAR T-cells in patients with R/R DLBCL.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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 refractory after 1st line systemic therapy or have a relapse after 12 months of finishing first line therapy or have R/R after at least 2 lines of systemic therapy
- •Age ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0-
- •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.
- •Approval by the Dutch CAR T-cell TumorBoard for lymphoma
排除标准
- •Absolute neutrophil count (ANC) <1.0x109/L.
- •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 immunnosupressive 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 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.
- •Platelet count <50x109/L.
- •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.
- •Absolute lymphocyte count <0.1x109/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 0.20x109/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.
结局指标
主要结局
PFS from date of IMP infusion (if applicable).
PFS from date of IMP infusion (if applicable).
次要结局
- PFS from date of randomization.
- Safety and toxicity assessment of ARI-0001 CAR T-cells and Axi-cel per AE reporting classified according to CTCAE Version 5 and CRS and ICANS classified according to the ASTCT criteria.
- Overall response rate (ORR, sum of complete response [CR] and partial response [PR]), as well as CR, PR, SD and PD/relapse at 4 weeks, 12 weeks, 6, 12 and 24 months after infusion of CAR T-cells.
- Expansion, phenotype and persistence of ARI-0001 CAR T-cells in both treatment arms.
- Best overall response (BOR) rate at 4 weeks, 12 weeks, 6, 12 and 24 months after infusion of CAR T-cells.
- Duration of response (DOR).
- OS from date of randomization, and from date of CAR T-cell infusion (if applicable).
- Patient Reported Outcome/Quality of Life (PRO/QOL).
- CAR T-cell expansion, persistence, and T-cell characteristics in both treatment arms (ARI-0001 vs Axi-cel).
- PoC CAR T-cell production characteristics (e.g. number of viable T-cells, transduction efficiency, T-cell subsets (activated T-cells, memory T-cells)), including the functional characteristics (e.g. potency tests) between the different production sites.
- The association of the functional characteristics (e.g. potency tests) of the CAR T-cell products (ARI-0001 CAR T-cells) with CAR T-cell expansion, persistence, adverse events, response rates and progression free survival.
- Proportion of successful batches between the different production sites.
- Number of days between leukapheresis and infusion of CAR T-cells (vein-to-vein time).
- Fludarabine pharmacokinetics.
研究者
M. Breems
Scientific
Universitair Medisch Centrum Groningen
研究点 (7)
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