EUCTR2017-001965-26-ES进行中（未招募）1 期
A SINGLE ARM, OPEN-LABEL, MULTI-CENTRE, PHASE I/II STUDY EVALUATING THE SAFETY AND CLINICAL ACTIVITY OF AUTO4, A CAR T CELL TREATMENT TARGETING TRBC1, IN PATIENTS WITH RELAPSED OR REFRACTORY TRBC1 POSITIVE SELECTED T CELL NON-HODGKIN LYMPHOMA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Autolus Ltd
- 入组人数
- 200
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
入选标准
- •1. Male or female, aged =18 years.
- •2. Willing and able to give written, informed consent to the study.
- •3. Confirmed diagnosis of selected T-NHL including:
- •a. Peripheral T cell lymphoma, not otherwise specified (NOS), or
- •b. Angioimmunoblastic T cell lymphoma or
- •c. Anaplastic large cell lymphoma.
- •4. Confirmed TRBC1 positive tumour.
- •5. Relapse or refractory disease and have had =1 prior lines of therapy.
- •6. Positron emission tomography (PET)-positive measurable disease per Lugano classification.
- •7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- •8. Adequate Bone Marrow Function without the requirement for ongoing blood products or and meets the following criteria:
- •a. Absolute Neutrophil Count =1.0 x 10e9/L
- •b. Absolute lymphocyte count =0.5 x 10e9/L (at entry and prior to leukapheresis)
- •c. Haemaglobin =80g/L
- •d. Platelets =75 x 10e9/L
- •9. Adequate renal, hepatic, pulmonary, and cardiac function defined as:
- •a. Creatinine clearance (as estimated by Cockcroft Gault) =60 cc/min.
- •b. Serum alanine aminotransferase / aspartate aminotransferase =2.5 x upper limit of normal ULN.
- •c. Total bilirubin =25 µmol/L (1.5 mg/dL), except in subjects with Gilbert’s syndrome.
- •d. Left ventricular ejection fraction (LVEF) =50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA) cardiac scan, unless the
- •institutional lower limit of normal is lower
- •e. Baseline oxygen saturation >92% on room air and =Grade 1 dyspnoea
- •10. For females of childbearing potential (defined as <2 years after last menstruation or not surgically sterile), a negative serum or urine pregnancy test must be documented at screening, prior to preconditioning and confirmed before receiving the first dose of study treatment.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Patients with T cell leukaemia.
- •2. Females who are pregnant or lactating.
- •3. Prior treatment with investigational or approved gene therapy or genetically engineered cell therapy product or allogeneic stem cell transplant.
- •4. Known history or presence of clinically relevant central nervous system (CNS) pathology, such as epilepsy, paresis, aphasia, stroke within the prior 3 months, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the CNS.
- •5. Current or history of CNS involvement by malignancy.
- •6. Clinically significant, uncontrolled heart disease (New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick-sinus syndrome, or electrocardiographic evidence of acute ischaemia or Grade 3 conduction system abnormalities unless the patient has a pacemaker) or a recent (within 12 months) cardiac event.
- •a. Uncontrolled cardiac arrhythmia (rate-controlled atrial fibrillation are not excluded).
- •b. Evidence of pericardial effusion.
- •7. Patients with evidence of uncontrolled hypertension or with a history of hypertension crisis or hypertensive encephalopathy.
- •8. Patients with a recent history or evidence of deep vein thrombosis or pulmonary embolism requiring ongoing therapeutic anticoagulation at the time of pre-conditioning.
- •9. Patients with active gastrointestinal (GI) bleeding.
- •10. Patients with any major surgical intervention in the last 3 months.
- •11. Active infectious bacterial, viral disease or fungal disease (hepatitis B virus,hepatitis C virus, human immunodeficiency virus [HIV], human T cell lymphotropic virus [HTLV] or syphilis) requiring treatment.
- •12. Active autoimmune disease requiring immunosuppression.
- •13. History of other neoplasms unless disease free for at least 2 years (adequately treated carcinoma in situ, curatively treated non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed).
- •14. Prior treatment with programmed cell death protein 1 (PD1), programmed death-ligand 1 (PD-L1), or cytotoxic T lymphocyte-associated protein 4 (CTLA-4) targeted therapy, or tumour necrosis factor (TNF) receptor superfamily agonists including CD134 (OX40), CD27, CD137 (41BB), and
- •CD357 (glucocorticoid-induced TNF receptor family-related protein) within 6 weeks prior to AUTO4 infusion.
- •15. The following medications are excluded:
- •a. Steroids: Therapeutic doses of corticosteroids within 72 hours of leukapheresis or pre-conditioning chemotherapy administration. However, physiological replacement, topical, and inhaled steroids are permitted.
- •b. Cytotoxic chemotherapies within 2 weeks prior to leukapheresis or AUTO4 infusion.
- •c. Antibody therapy use within 2 weeks prior to AUTO4 infusion, or five half-lives of the respective antibody, whichever is shorter.
- •d. Live vaccine within 4 weeks prior to enrolment.
- •16. Research participants receiving any other investigational agents, or concurrent b
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