NL-OMON53302撤回不适用
A Phase 1/2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 (MAGE-A1-Directed TCR-Transduced Autologous CD8+ T-cells) in Patients with HLA-A*02:01 Genotype and Advanced-Stage/Metastatic, MAGE-A1+ Solid Tumors that Either Have No Further Approved Therapeutic Alternative(s) or are not Eligible for them or are in a Non-Curable State and Have Received a Minimum of Two Lines of Systemic Therapy - Immunotherapeutic MAGE A-1 Directed Neoplasm Elimination
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- T-knife GmbH
- 入组人数
- 3
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 99（—）
入选标准
- •Each subject must meet all of the following inclusion criteria to be eligible
- •to enroll in this trial and to proceed to TK-8001 treatment:
- •1. Ability to understand the intent of the trial and provision of a signed and
- •dated informed consent from the subject prior to performing any
- •protocol-related procedures (including screening evaluations), and ability to
- •comply with the trial procedures and any locally required authorization
- •2. Age >= 18 years
- •3. Presence of an advanced-stage/metastatic, solid tumor in non-curable state:
- •a. For which there is either no approved therapeutic alternative available or
- •the subject is not eligible for them or
- •b. For which the subject has received a minimum of two lines of approved
- •systemic therapy
- •NB: Screening I and apheresis may take place during the line of treatment
- •immediately preceding the planned TK-8001 treatment to avoid delays due to
- •manufacturing time in progressing subjects
- •4. HLA-A*02:01 genotype
- •5. MAGE-A1+ tumor as per IHC
- •6. As per most recent tumor assessment, presence of radiologically measurable
- •disease - with at least 1 lesion, not previously irradiated, that can be
- •accurately measured as per RECIST V1.1 with CT or MRI and that is not
- •considered for on-treatment biopsy
- •7. ECOG performance status <= 1
- •8. Life expectancy > 3 months as assessed by the Investigator
- •9. Adequate organ function, defined as:
- •a. Bone marrow function: hemoglobin >= 10 g/dL (equal to 6.2 mmol/L); platelet
- •count >= 100 × 109 /L; leukocyte count >= 3.0 × 109 /L; absolute lymphocyte count
- •>= 0.65 × 109/L. Note: absolute lymphocyte count >= 0.65 × 109/L criterion only
- •applies to Screening I.
- •b. Hepatic function: aspartate transaminase (AST) and alanine transaminase
- •(ALT) <= 3.0×upper limit of normal (ULN); bilirubin <= 2.0xULN
- •c. Renal function: serum creatinine < 1.5×ULN and/or creatinine clearance >= 50
- •mL/min (Cockcroft-Gault equation).
- •d. International normalized ratio (INR) < 1.5 and partial thromboplastin time
- •(PTT) within 1.25 × of upper and lower limit of normal
- •10. All toxicities related to prior radiotherapy, chemotherapy, or surgical
- •procedure must have recovered to baseline or Grade <= 1 based on the National
- •Cancer Institute - Common Terminology Criteria for AEs v5.0, except alopecia
- •(any grade), and AEs that are regarded clinically nonsignificant
- •or stable on supportive therapy as per treating physician's assessment
- •Note: In case of Screening I and apheresis taking place during a prior line of
- •treatment this criterion applies only to Screening II
- •11. Ongoing immune-related adverse events from previous therapies must have
- •recovered to baseline or Grade <= 1 except vitiligo, hair loss, and stable
- •endocrinopathies with physiologic hormone repletion
- •NB: In case of Screening I and apheresis taking place during a prior line of
- •treatment, this criterion applies only to Screening II
- •12. Women of non-childbearing potential due to surgical sterilization (at least
- •6 weeks following surgical bilateral oophorectomy with or without hysterectomy
- •or tubal ligation) confirmed by medical history or menopause (i.e., no
- •menstrual bleeding for more than 12 months in a woman aged >= 45 years).
- 另有 2 项未显示
排除标准
- •Each subject fulfilling any of the following exclusion criteria is not eligible
- •to enroll in this trial and to proceed to TK-8001 treatment:
- •1. Has received any approved or non-approved tumor-directed therapy within 14
- •days before start of conditioning therapy
- •2. Has received any other MAGE-A1-targeting therapy
- •3. Pre-existing arrhythmia, considered to be of concern as per clinical
- •assessment (e.g. uncontrolled atrial fibrillation, significant ventricular
- •tachy-/arrhythmia [CTCAE Grade >= 2], significant bradycardia, or highergrade
- •AV-block among others) ,uncontrolled angina pectoris, diagnosed with at present
- •uncontrolled heart failure (New York Heart Association II-IV), or any
- •myocardial infarction/coronary event as well as any CNS-ischemic event and any
- •thromboembolic event within 6 months prior to screening
- •4. Left ventricular ejection fraction (LVEF) <45% as measured by an
- •echocardiogram or multigated acquisition (MUGA) scan
- •5. Corrected QT interval by the Fredericia formula (QTcF) >450 ms for men or
- •>470 ms for women
- •6. History of CNS disease such as stroke, seizure, encephalitis or multiple
- •sclerosis (within 6 months prior to screening)
- •7. Active allergy requiring continuous systemic medication or active infections
- •requiring IV/orally (PO) anti-infectious therapy within 7 days prior to
- •conditioning therapy
- •8. History of or clinical evidence of CNS primary tumors or metastases
- •(including leptomeningeal metastases), unless they have been previously treated
- •are asymptomatic, considered inactive by brain imaging and have been stable for
- •at least 4 weeks prior to trial entry/TK-8001 treatment
- •9. Systemic steroids at a daily dose of >5 mg of prednisolone except
- •non-systemic (inhaled, topical, or nasal), for the last 14 days prior to
- •planned date for leukapheresis
- •10. Evidence of any form of active rheumatoid arthritis or active joint
- •inflammation
- •11. Subjects with rapidly progressing disease (as per Investigator assessment),
- •which may predispose to inability to tolerate treatment and/or trial procedure
- •12. Major surgery within last 4 weeks prior to consent
- •13. Known/expected hypersensitivity against TK-8001, dimethyl sulfoxide (DMSO),
- •and/or other cellular therapy components
- •14. Active disease/ongoing infection in regard to human immunodeficiency virus
- •(HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), tuberculosis (TB),
- •syphilis (Treponema pallidum [TPHA]), or
- •severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (by PCR)
- •15. Any other diseases, metabolic dysfunction, physical examination finding, or
- •clinical laboratory abnormality giving reasonable suspicion of a disease or
- •condition that in the opinion of the Investigator would contraindicate the use
- •16. Receipt of any organ transplantation, including autologous or allogeneic
- •hematopoietic cell transplantation, but with the exception of transplants that
- •do not require immunosuppression (e.g., corneal transplant, hair transplant)
- •17. Any vaccine administration within 4 weeks of IP administration. Vaccination
- •with live vaccines while on trial is not permitted unless of vital medical
- •necessity and outside the Conditioning, TK-8001 Treatment, and Monitoring
- •18. Subject is pregnant or breastfeeding
- •19. Known active drug or alcohol abuse
研究者
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