EUCTR2018-001608-12-DE进行中（未招募）1 期
A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144/LN-145/LN-145-S1) in Patients with Solid Tumors - Study of LN-144, LN-145, and LN-145-S1 in the Treatment of Patients with Solid Tumours
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 178
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. All patients must have a histologically or pathologically confirmed
- •diagnosis of malignancy:
- •-Unresectable or metastatic melanoma Stage III C to IV (Cohorts 1A,1B, and 1C)
- •- Advanced, recurrent, or metastatic HNSCC (Cohort 2A)
- •- Stage III or Stage IV NSCLC (Cohorts 3A, 3B, and 3C)
- •2. Cohorts 1A, 2A, and 3A: If previously treated, patients must have
- •progressed on or after most recent therapy and must not have received CPIs as part of one of the counted lines of prior therapy. Patients must have radiologically documented disease progression while receiving or after the completion of the most recent prior treatment. Patients may have received up to 3 prior systemic anticancer therapies, (except for Cohort 3A, where patients may have received up to 4 prior systemic therapies)
- •3. Cohorts 1C, 3B, and 3C: Unresectable or metastatic melanoma
- •patients in Cohorts 1C must have previously received systemic therapy with a PD-1 blocking antibody. NSCLC patients in Cohort 3B must have previously received systemic therapy with any CPI (except for those patients with known oncogene driver mutations that are sensitive to targeted therapies) as part of 1-3 prior lines of therapy. NSCLC patients in Cohort 3C must have previously received 1 line of CPI monotherapy. No other systemic therapy for metastatic disease is allowed. Prior chemoradiation and/or chemotherapy in the adjuvant and/or neoadjuvant settings are allowed
- •4. Patients must have at least 1 resectable lesion (or aggregate lesions) that, in the assessment of the Investigator, has an expected minimum 1.5 cm diameter for TIL production. It is encouraged that tumor tissue be obtained from multiple and diverse metastatic lesions, as long as the surgical resection does not pose additional risks to the patient.
- •5.Patients must have a remaining measurable disease as defined by
- •RECIST 1.1 following tumor resection for TIL manufacturing
- •6.Patients must be =18 years in all cohorts except 1B, where patients
- •must be = 12 years at the time of consent
- •7.Patients must have an Eastern Cooperative Oncology Group
- •performance status of 0 or 1, and an estimated life expectancy of =6
- •months in the opinion of the Investigator.
- •8. Patients of childbearing potential or those with partners of
- •childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and for 12 months after their last dose of IL-2, 4 months after their last dose of pembrolizumab, or 5 months after their last dose of ipilimumab or nivolumab, whichever occurs later. Males may not donate sperm, females may not donate eggs during the required contraception period
- •9. Patients must have the following hematologic parameters:
- •Absolute neutrophil count =1000/mm3
- •Hemoglobin =8.0 g/dL
- •Platelet count =100,000/mm3
- •10. Patients must have adequate organ function:
- •ALT/ SGPT and AST/SGOT =3 times the upper limit of normal, patients with liver metastasis =5 times ULN
- •An estimated creatinine clearance =40 mL/min at screening using the Cockcroft Gault formula
- •Total bilirubin =2 mg/dL
- •Patients with Gilbert's Syndrome must have a total bilirubin =3 mg/dL
- •11. Patients must have no evidence of any active viral, bacterial, or
- •fungal infection requiring ongoing systemic treatment or as per required screening tests
- •12. Patients must have a washout period from prior anticancer therapy(ies) of a minimum duration as defined in the protocol (ie, start of NMA LD or pembrolizumab or ipilimumab/nivolumab)
排除标准
- •1.Patients with melanoma of uveal/ocular origin
- •2.Pts. who have a history of allogeneic organ transplant or any form
- •of cell therapy involving prior conditioning chemotherapy within the
- •past20 years. Pts. being retreated with TIL as part of this study are
- •not excluded.
- •3.Pts. who have symptomatic untreated brain metastases. Patients
- •with brain metastases may be enrolled with the following considerations and only after discussion with the Medical Monitor:
- •Patients with asymptomatic brain metastases who do not clinically require treatment may be enrolled.
- •Patients with historically treated brain metastases (ie,
- •treatment of brain metastases was completed >28 days prior to date of informed consent) will be considered for enrollment if the patient is clinically stable for =2 weeks, there are no new or worsening brain
- •lesions via screening magnetic resonance imaging (MRI), and the patient does not require ongoing corticosteroid treatment(> 10 mg/day prednisone or equivalent).
- •Patients with recently treated brain metastases (ie, treatment of brain metastases was completed =28 days prior to date of informed consent) may be considered for enrollment if the patient is asymptomatic, clinically stable for =2 weeks, and does not
- •require corticosteroids (>10 mg/day prednisone or equivalent) by the
- •end of the screening period.
- •Patients with progressive or new brain metastases on screening MRI should suspend screening procedures and receive appropriate treatment of brain metastases. Screening can resume after completion of brain metastases treatment, when the patient is asymptomatic, clinically stable for =2 weeks, and does not
- •require corticosteroids (>10 mg/day prednisone or equivalent) for at
- •least 7 days.
- •4.Patients who are on systemic steroid therapy > 10 mg/day of
- •prednisone or other steroid equivalent
- •5.Patients who are pregnant or breastfeeding
- •6.Patients who have an active medical illness(es), which in the opinion of the Investigator, would pose increased risks for study participation; such as systemic infections, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems
- •7. Cohort 1A, 2A, 3A, and 3C patients may not have active autoimmune disorders (including pneumonitis and uveitis) that require active treatment. Patients with a history of uveitis must have an eye examination performed by a trained eye specialist at Screening to rule out active uveitis. The following are exceptions to this criterion:
- •Patients with vitiligo or alopecia;
- •Patients with thyroid dysfunction (eg, following Hashimoto syndrome) stable on hormone replacement;
- •Any chronic skin condition that does not require systemic therapy; or
- •Patients with celiac disease controlled by diet alone
- •8.Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment.
- •9.Patients who have any form of primary immunodeficiency (such as
- •severe combined immunodeficiency disease [SCID] and acquired
- •immune deficiency syndrome [AIDS]).
- •10.Patients with a history of hypersensitivity to any component of the study drugs. TIL should not be administered to patients with a known hypersensitivity to any component of TIL product formulation including, but not limited to any of the following:
- •NMA-LD (cyclophosphamide, mesna, and fludarabine)
- •Proleukin®, aldesleukin, IL-2
- •Antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)
- •Any component of the TIL product formulation incl
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