NL-OMON56213招募中2 期
A Multicentre, Open-Label, Single Ascending Dose, Dose-Ranging, Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant Recipients. - A phase 1/2a study of TX200-TR101 in renal transplant recipients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 8
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
- •Inclusion Criteria (All Transplant Recipients)
- •1. Willing and able to provide written informed consent (IC) in accordance with
- •local regulations and governing Independent Ethics Committee
- •(IEC)/Institutional Review Board (IRB) requirements prior to any procedure or
- •evaluation performed specifically for the sole purpose of the study.
- •2. Male or female aged between 18 and 70 (inclusive) years.
- •3. Have diagnosis of ESRD and currently waiting for a new kidney from an
- •identified live donor.
- •4. Subjects who will be single organ recipients (kidney).
- •5. Normal or non-clinically significant abnormality in the electrocardiogram
- •(ECG), at investigator*s discretion.
- •6. Women who are of childbearing potential must have a negative serum pregnancy
- •test at screening and before transplantation.
- •7. Able and willing to use a highly effective method of contraception from the
- •signing of the informed consent through the last study visit, for male and
- •female subjects with reproductive potential.
- •Additional Inclusion Criteria (Transplant Recipients to be Administered TX200
- •TR101 Only)
- •1. HLA-A*02 negative typing (the kidney graft needs to be HLA A*02 positive).
- •2. HLA-A*69 negative typing.
- •3. Adequate venous access for leukapheresis, and no other contraindications for
- •leukapheresis.
- •4. Subjects that have a transplant planned or scheduled for at least 10
- •weeks after the time of enrolment.
- •Inclusion Criteria (All Transplant Donors)
- •1. Willing and able to provide written IC in accordance with local regulations
- •and governing IEC/IRB requirements prior to any procedure or evaluation
- •performed specifically for the sole purpose of the study.
- •2. Aged at least 18 years on the day of signing the IC form.
- •3. ABO blood type compatible with the organ recipient.
- •4. Negative serology for HIV, HBV, HCV and syphilis.
- •5. Willing to provide personal and medical/biological data and samples for the
- •study analysis.
- •Additional Inclusion Criterion (Transplant Donors for Transplant Recipients to
- •be Administered TX200 TR101 Only)
- •1. HLA-A*02 positive typing.
排除标准
- •Exclusion Criteria (All Transplant Recipients) 1. HLA identical to the
- •prospective organ donor. 2. Subjects with prior organ transplant. 3. Known
- •hypersensitivity to study medication ingredients or a significant allergic
- •reaction to any drug as determined by the investigator, such as anaphylaxis
- •requiring hospitalisation. 4. Known hypersensitivity or contraindications for
- •anti-thymocyte globulin (ATG), tacrolimus or mycophenolic acid (MPA)/
- •mycophenolate mofetil (MMF). 5. Positive serology for human immunodeficiency
- •virus (HIV) or syphilis. 6. Evidence of active or occult hepatitis B virus
- •(HBV) or active hepatitis C virus (HCV) infection. 7. Subjects who are
- •Epstein-Barr Virus (EBV) seronegative. 8. Positive flow cytometric crossmatch
- •using donor lymphocytes (T and B cells) and recipient serum. 9. Subjects with
- •panel-reactive antibody (PRA) >20% within 6 months prior to enrolment. 10.
- •Subjects with current, recent or historical donor-specific antibodies. 11.
- •Previous treatment with any desensitisation procedure (with or without
- •intravenous immunoglobulin) 12. Subjects with underlying renal disease with a
- •high risk of disease reoccurrence in the transplanted kidney including primary
- •focal segmental glomerulosclerosis, C3 glomerulopathy, types I or II
- •membranoproliferative glomerulonephritis or haemolytic-uraemic syndrome (HUS),
- •including a typical HUS. If the subject has ESRD of unknown aetiology and/or
- •has no histologically confirmed diagnosis the subject may be enrolled into the
- •study if there are no clinical, laboratory, histological or genetic features
- •suggestive of a diagnosis of primary focal segmental glomerulosclerosis, types
- •I or II membranoproliferative glomerulonephritis, C3 glomerulopathy, or HUS,
- •including atypical HUS, as deemed by the investigator. 13. Concomitant
- •clinically active local or systemic infection. 14. Use of any experimental
- •medicinal product within 3 months or 5 half-lives prior to the screening visit,
- •whichever is longer, and agreement to not take any experimental medicinal
- •product throughout the trial. 15. Subjects who are currently receiving systemic
- •immunosuppressive agents (e.g., methotrexate, infliximab, adalimumab,
- •corticosteroids) for other indications such as autoimmune diseases, or subjects
- •with comorbidities for which treatment with such agents are likely during the
- •study, with the following exception: • Subjects who are receiving or may
- •require short-term and/or low dose (e.g., prednisone or prednisone equivalent <
- •5 mg daily) or methotrexate (e.g. 15 mg weekly) courses of corticosteroids are
- •not precluded from enrolment, at the discretion of the investigator in
- •consultation with the Sponsor*s Medical Monitor. 16. Clinical evidence of
- •significant unstable or poorly controlled acute or chronic diseases (i.e.,
- •cardiovascular, pulmonary, haematologic, gastrointestinal, hepatic,
- •neurological, or infectious diseases) or laboratory abnormality (except ESRD)
- •which, in the opinion of the investigator, could confound the results of the
- •study or put the subject at undue risk. • Subjects who, at the discretion of
- •the investigator, are deemed at high risk of a renal thrombotic event. 17.
- •Subjects with current or previous history of clinically relevant central
- •nervous system pathology (including but not limited to seizures within the las
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