EUCTR2018-001608-12-GR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
- 135
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 IIIC or Stage IV (Cohorts
- •- 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 drivers who have mutations that are sensitive to targeted
- •therapies) as part of 1-3 prior lines of therapy. NSCLC patients in Cohort
- •3C must have received prior systemic therapy with an approved
- •monotherapy CPI as their single prior line of systemic therapy.
- •4. Patients must have at least 1 resectable lesion (or aggregate lesions)
- •of a minimum 1.5 cm in diameter post-resection for TIL investigational
- •product 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 at the time of consent in all cohorts.
- •Enrollment of patients > 70 years of age may be allowed after
- •consultation with the Medical Monitor.
- •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
- •receiving all protocol-related therapy
- •9. Patients must have the following hematologic parameters
- •independent of transfusion and/or blood product support for at least 5
- •days prior to laboratory testing:
- •Absolute neutrophil count =1000/mm3
- •Hemoglobin =9.0 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
- 另有 9 项未显示
排除标准
- •1.Patients with melanoma of uveal/ocular origin
- •2.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. Note: This criterion is
- •applicable for patients undergoing retreatment with TIL, with the
- •exception that they will have had a prior NMA-LD regimen with their
- •prior TIL treatment.
- •3.Patients with symptomatic and/or untreated brain metastases.
- •Patients with historically (prior to consenting for study participation)
- •treated brain metastases will be considered for enrollment if the patient
- •is clinically stable for = 2 weeks, there are no new brain lesions via
- •screening magnetic resonance imaging (MRI), and the patient does not
- •require ongoing corticosteroid treatment. If there are progressive or
- •new brain metastases on screening MRI, the patient should first receive
- •treatment for them prior to consideration of enrollment. Follow up
- •imaging post-treatment is not required to enroll.
- •Patients with recently (during screening period or within 28 days prior
- •to enrollment) treated brain metastases may be considered for
- •enrollment if the patient is asymptomatic, clinically stable for = 2 weeks
- •and not requiring corticosteroid by the end of the screening period.
- •Follow up imaging post-treatment is not required to enroll. Medical
- •monitor approval is required.
- •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 (eg, syphilis or any other infection requiring
- •antibiotics), 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 a medical history of
- •autoimmune disorders (including pneumonitis) requiring treatment or
- •active management. 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
- 另有 10 项未显示
研究者
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