EUCTR2022-003137-19-DE进行中（未招募）1 期
An open-label phase I/IIa, multicenter, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE - MB-CART19.1 in refractory SLE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- 性别
- All
入选标准
- •1. Patients at least 18 years of age
- •2. Signed and dated informed consent before the conduct of any trial-specific procedure
- •3. SLE fulfilling the 2019 ACR/EULAR classification criteria (refer to Appendix 8)
- •4. One BILAG A or two BILAG B despite treatment with at least two of the following treatment options: MMF, cyclophosphamide, rituximab belimumab, anifrolumab, methotrexate, azathioprine
- •5. SLE with major organ involvement defined as either:
- •a)Presence of active lupus nephritis according to the following criteria:
- •ohistology proven class III or IV lupus nephritis according to ISN/RPS 2003 classification;
- •oUrine protein-to-creatinine ratio (UPCR) >1 in 24-hour urine collection;
- •oGlomerular filtration rate (eGFR) of =30 mL/min/1.73 m2
- •oNo history of kidney transplantation.
- •b)Lupus with heart involvement (e.g. myocarditis, pericarditis, endocarditis) as measured by MRI or echocardiography/ultrasound
- •c)Lupus with pulmonary involvement (Lupus pleuritis, pulmonary arterial hypertension (PAH)) or lung disease defined as:
- •oForced Vital Capacity (FVC) = 60% OR
- •oForced Expiratory Volume (FEV1) = 60%, Total Lung Capacity (TLC) = 60% and DLCO (diffusion capacity) = 60%
- •6. Absolute CD3+ T cell count =100/µl;
- •7. No childbearing potential or negative pregnancy test at screening and before chemotherapy in women with childbearing potential; Subjects must agree to use a contraceptive method from screening until 12 months after the administration of the IMP.
- •8. Fully vaccinated against SARS-CoV2 according to the recommendations of RKI or confirmed SARS-CoV-2 infection within the last 6 months.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Criteria for Exclusion
- •Patients will be entered into this trial only if they meet none of the following criteria:
- •1. Active clinically significant central nervous system (CNS) dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis);
- •2. Uncontrolled diabetes mellitus.
- •3. Therapy induced lung disease and tuberculosis
- •4. Forced Vital Capacity (FVC) < 60%, FEV1 < 60%, Total Lung Capacity (TLC) < 60% and DLCO (diffusion capacity) < 60%.
- •5. BILAG A or BILAG B for neuropsychiatric SLE
- •6. History of a malignancy unless disease free for =5 years with the exception of basal or squamous cell skin cancer;
- •7. Cardiac function: unstable coronary heart disease; left ventricular ejection fraction (LVEF) < 50%; no active myocarditis
- •8. Renal function: eGFR < 30 ml/min/1.73 m2;
- •9. Liver function: Severe hepatic insufficiency defined as a Child-Pugh score = 10(C) (Appendix 10)
- •10. Known history of infection with human immunodeficiency virus or active infection with hepatitis B (hepatitis B surface antigen positive)
- •11. Known history of infection with hepatitis C virus unless treated and confirmed to be polymerase chain reaction (PCR) negative
- •12. Any active, uncontrolled bacterial, viral or fungal infection including SARS-CoV-2
- •13. History of hematopoietic stem cell or solid organ transplantation.
- •14. Irreversible organ damage.
- •15. Medications:
- •Systemic corticosteroids >10 mg within 7 days prior to leukapheresis;
- •T cell targeting drugs (e.g. mycophenolate mofetil, calcineurin inhibitors) within 21 days prior to leukapheresis,
- •Prior treatment with anti-CD19 therapy;
- •Previous adoptive T cell therapy or any gene therapy including CAR T cell therapy;
- •Live vaccines within 30 days prior to leukapheresis,
- •Current cytotoxic drugs
- •16. Hypersensitivity against any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory preparative chemotherapy or rescue medication/salvage therapies for treatment related toxicities;
- •17. Contraindication of trial related procedures as judged by the investigator
- •18. Women of childbearing potential (WOCBP) who do not agree to use highly effective contraceptive measures (Pearl index < 1) or practice true sexual abstinence from any heterosexual intercourse (true abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.) or must have a vasectomised partner as the sole sexual partner (The vasectomised partner must have received medical assessment of the surgical success.) for at least 1 month before the study start, during the study and in the 12 months following the last dose of study treatment.
- •A woman is considered a WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. WOCBP who want to become pregnant after completing treatment should seek advice about oocyte cryoconservation prior to treatment because of possible irreversible infertility. WOCBP must refrain from egg donation throughout the study until 12 months after the last dose of study treatment.
- •Highly effective methods of contraception include hormonal contraceptives associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable, implantable) and intrauterine devices or systems (e.g. hormonal and non-hormonal) and bilateral tubal occlusion.
- •Permanent sterilization methods include hysterec
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