2023-504632-17-00招募中2 期
A phase 2, Multicenter Study of TILs Treatment in Advanced Tumors with Alterations in the SWI/SNF Complex: the TILTS Study
Fundacio Institut D Investigacio Biomedica De Bellvitge IDIBELL, Fundacio Institut D Investigacio Biomedica De Bellvitge IDIBELL3 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2023年9月4日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- • ORR per RECIST v1.1 as assessed by investigator
研究概览
简要总结
To evaluate the efficacy of autologous TIL (VHIO-TIL-01) as a single therapy in patients affected by unresectable or advanced tumors with alterations in the SWI-SNF complex, as determined by ORR, using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Investigator
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •3.All patients must have a pathologically confirmed diagnosis of solid tumors associated with SWI/SNFc-mutated monogenic diseases. These solid tumors include, but are not limited to: - Epithelioid sarcoma - Malignant rhabdoid tumor - Small cell carcinoma of the ovary, hypercalcemic type (SCCOHT) - Renal medullary carcinoma - Epithelioid malignant peripheral nerve sheath tumor (EMPNST) - Myoepithelial carcinoma - Extra-skeletal myxoid chondrosarcoma - Poorly differentiated chordoma - Sinonasal basaloid carcinoma
- •Patients must have a measurable disease as defined by RECIST 1.1: - Lesions in previously irradiated areas should not be selected as target lesions unless there has been demonstrated progression in those lesions. - Lesions that are partially resected for TIL generation that are still measurable per RECIST may be selected as target lesions
- •Patients must have a washout period from prior anticancer therapy(ies) of a minimum duration, as detailed below prior to the first study treatment (ie, start of NMA-LD). - Chemotherapy: adjuvant, neoadjuvant or definitive chemotherapy/ chemoradiation is allowed provided the washout is a minimum of 21 days, prior to the start of treatment. - Prior immunotherapy, checkpoint-targeted therapy, other monoclonal antibodies (mAbs), or vaccines are allowed if disease progression is confirmed prior to or within the washout period of ≥21 days prior to the start of NMA-LD
- •Palliative radiation therapy: prior external beam radiation is allowed at least 2 weeks before TILs infusion provided all radiation-related toxicities are resolved to Grade 1 or baseline, excluding alopecia, skin pigmentation change, or other clinically insignificant events, eg, small area radiation dermatitis or rectal or urinary urgency.
排除标准
- •Patients who have received an organ allograft or prior cell transfer therapy that included a nonmyeloablative or myeloablative chemotherapy regimen within the past 20 years
- •Patients with symptomatic and/or untreated brain metastases: - Patients with definitively-treated brain metastases will be considered for enrollment if, prior to the start of treatment the patient is clinically stable for ≥ 2 weeks, there are no new brain lesions via magnetic resonance imaging (MRI) post-treatment, and the patient does not require ongoing corticosteroid treatment.
- •Patients requiring regular treatment with steroids at a dose higher than prednisone 10mg/day (or equivalent)
- •Patients may not have active or prior documented autoimmune or inflammatory disorders (including pneumonitis, inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]).
- •Patients with a history of hypersensitivity to any of the folowing drugs including, but not limited to, the components of the study drugs and any component of TIL product formulation: - NMA-LD (cyclophosphamide, mesna, and fludarabine) - Proleukin®, aldesleukin, IL-2 - Antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin [excluding those who are skin-test negative for gentamicin hypersensitivity]) - Any component of the TIL product formulation including dimethyl sulfoxide [DMSO], human serum albumin [HSA], IL-2, and dextran-40
- •Patients who have a left ventricular ejection fraction (LVEF) <45% or who are New York Heart Association (NYHA) Class II or higher
- •Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) ≤50% of predicted normal
- •Patients who have had another primary malignancy within the previous 3 years (except for those which do not require treatment or have been curatively treated >1 year ago, and in the judgment of the Investigator, does not pose a significant risk of recurrence including, but not limited to, non-melanoma skin cancer, DCIS, LCIS, prostate cancer Gleason score ≤6 or bladder cancer).
结局指标
主要结局
• ORR per RECIST v1.1 as assessed by investigator
• ORR per RECIST v1.1 as assessed by investigator
次要结局
- • Toxicity evaluation: nature and frequency of Adverse Events (AE), Severe Adverse Events (SAE), Treatment-limiting Toxicity (TLT), alterations in clinical, laboratory test results, ECGs, vital sign measurements, physical examination findings graded, when applicable, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- • CRR per RECIST v1.1 as assessed by investigator
- • DOR per RECIST v1.1 as assessed by investigator
- • DCR per RECIST v1.1 as assessed by investigator
- • PFS per RECIST v1.1 as assessed by investigator
- OS
研究者
Juan Martín Liberal
Scientific
Fundacio Institut D Investigacio Biomedica De Bellvitge IDIBELL
研究点 (3)
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