CTIS2023-504632-17-00进行中（未招募）1 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 IDIBE0 个研究点目标入组 11 人开始时间: 2023年5月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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, 4. 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, 11.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, 12.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
- •1.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, 2.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., 3.Patients requiring regular treatment with steroids at a dose higher than prednisone 10mg/day (or equivalent), 6.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.])., 9.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, 10.Patients who have a left ventricular ejection fraction (LVEF) <45% or who are New York Heart Association (NYHA) Class II or higher, 11.Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) =50% of predicted normal, 12.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).
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