EUCTR2017-002877-20-DK进行中（未招募）1 期
An open-label phase II single-centre study investigating the safety and efficacy of LTX-315 and adoptive T-cell therapy in patients with advanced/metastatic soft tissue sarcoma
ytix Biopharma AS0 个研究点目标入组 6 人开始时间: 2018年2月1日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
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. (Histologically) Confirmed any patients with advanced or metastatic soft tissue sarcoma with stable disease or has progressed after a minimum of 1 systemic treatment of advanced/metastatic disease. Patient will have received at least 1 approved standard of care treatment for advanced/metastatic disease or be deemed unsuitable for such treatment by their treating physician
- •2. At least 1 index tumour lesion accessible for injection with a longest diameter (LD) of = 1cm which is planned for LTX-315 injection
- •3. At least 1 measurable (target) non-injected tumour lesion that can be used to assess response by Computed Tomography (CT-scan) (as per RECIST)
- •4. A life expectancy of at least 3 months
- •5. Willing to undergo repeat tumour biopsy and/or tumour resection procedures
- •6. Between 18 and 75 years of age
- •7. An Eastern Cooperative Oncology Group (ECOG) performance status: 0 – 1
- •8. Meet the following blood laboratory requirements:
- •a. Absolute neutrophil count (ANC) = 1.5 x 109/L
- •b. Platelet count = 75 x 109/L
- •c. Haemoglobin = 6.0 mmol/L after blood transfusion if needed
- •d. Prothrombin time / International Normalised Ratio (PT/INR) within the
- •institution’s normal range
- •e. Aspartate Transferase (AST) and Alanine Transferase (ALT) = 2.5 x upper normal level
- •f. Creatinine = 1.5 x upper normal level
- •9. Willing and able to comply with the protocol and agree to return to the hospital for follow-up visits and examinations up to 15 months after EoT
- •10. Fully informed about the study and have signed the informed consent form
- •11. Re-screening is allowed once on a case by case basis as judged by the investigator
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. A history of clinical significant active systemic autoimmune disease requiring antiinflammatory or immunosuppressive therapy within the last 3 months. Patients with history of autoimmune thyroiditis are eligible provided the patient requires only thyroid hormone replacement therapy and disease has been stable for = 1 year
- •2. Any other malignancy active within the previous 5 years except for carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of the breast
- •3. Received an investigational drug within 4 weeks prior to any study drug administration, or are scheduled to receive 1 during the study participation
- •4. Received external radiotherapy or cytotoxic chemotherapy within 4 weeks prior to LTX-315 administration, or have not recovered from AEs (to = CTCAE grade 1) due to agents administered more than 4 weeks earlier. Palliative radiotherapy to nontarget and lesions planned for LTX-315 injection within 4 weeks of LTX-315 administration is allowed
- •5. Currently taking any agent with a known effect on the immune system. Patients are allowed to be on a stable dose of corticosteroids (up to 10 mg daily prednisolone or equivalent) for at least 2 weeks prior to LTX-315 administration
- •6. Any other serious illness or medical condition such as, but not limited to:
- •a. Uncontrolled infection or infection requiring antibiotics
- •b. Uncontrolled cardiac failure: Classification III or IV (New York Heart
- •Association)
- •c. Uncontrolled systemic and gastrointestinal inflammatory conditions
- •d. Bone marrow dysplasia
- •7. A known history of positive tests for HIV/AIDS, syphilis, human T-cell leukemialymphoma virus (HTLV), active Epstein-Barr, hepatitis B or C (based on serology)
- •8. A history of cerebrovascular or cardiac disorders and would be at particular risk of sequelae following a short hypotensive episode
- •9. If of child-bearing potential, not willing to use an effective form of contraception such as hormonal birth control, intrauterine device or double barrier method from screening visit and until 3 months after last study treatment (any of the agents)
- •10. Breastfeeding and/or have a positive pregnancy test during screening
- •11. Donate sperm from LTX-315 dosing until 3 months after last study treatment (any of the agents)
- •12. Patients with pregnant or partner of child-bearing potential not willing to use contraception from LTX-315 administration until 3 months after last study treatment (any of the agents)
- •13. Expected to need any other anticancer therapy or immunotherapy to be initiated during the treatment period
- •14. Clinically active or unstable metastases in the central nerveous system as assessed by the treating physician
- •15. Any known hypersensitivity to any of the excipients in the non-IMPs including the required allergic prophylactic medications (H1 and H2 antagonists, Leukotriene antagonists)
- •16. Any known or suspected hypersensitivity to any of the IMPs
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