2024-512579-11-00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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Incidence and grade of TEAEs, including SAEs, within 28 days post TX200-TR101 infusion.
研究概览
简要总结
To evaluate the short-term safety and tolerability of TX200-TR101 from the day of TX200-TR101 infusion within 28 days post TX200-TR101 infusion.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.
- •Male or female aged between 18 and 70 (inclusive) years.
- •Have diagnosis of ESRD and currently waiting for a new kidney from an identified live donor.
- •Subjects who will be single organ recipients (kidney).
- •Normal or non-clinically significant abnormality in the electrocardiogram (ECG), at investigator’s discretion.
- •Women who are of childbearing potential must have a negative serum pregnancy test at screening and before transplantation.
- •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.
排除标准
- •1.HLA identical to the prospective organ donor.
- •2.Subjects with prior organ transplant.
- •3.Positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
- •4.Subjects with panel-reactive antibody (PRA) greater than 20% within 6 months prior to enrolment.
- •Subjects with current or recent (within 6 months) donor-specific antibodies.
- •Subjects with underlying renal disease with a high risk of disease reoccurrence in the transplanted kidney including primary focal segmental glomerulosclerosis, types I or II membranoproliferative glomerulonephritis, C3 glomerulopathy, or haemolytic-uraemic syndrome (HUS), including atypical HUS.
- •Concomitant clinically active local or systemic infection.
- •Clinical evidence of significant unstable or uncontrolled acute or chronic diseases (i.e., cardiovascular, pulmonary, haematologic, gastrointestinal, hepatic, neurological, malignancy 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.
结局指标
主要结局
Incidence and grade of TEAEs, including SAEs, within 28 days post TX200-TR101 infusion.
Incidence and grade of TEAEs, including SAEs, within 28 days post TX200-TR101 infusion.
次要结局
- 1. From the day of TX200-TR101 infusion through to Week 84 - Incidence of BCAR according to the Banff criteria, Time to first BCAR episode, Type and severity of any BCAR episodes according to the Banff criteria.
- 2. From the day of TX200-TR101 infusion through to Week 84: Incidence and grade of TEAEs, including SAEs. Incidence of opportunistic infections, specifically BKV, EBV and CMV reactivation. Incidence of neoplasia.
- 3. Proportion of subjects who are receiving tacrolimus monotherapy at Week 84., Cumulative dose of immunosuppression, including but not limited to MPA/MMF and tacrolimus through to Week 84.
- 4. Presence of CD4 positive cells that are also positive for HLA-A2 CAR RNA transcripts in the renal transplant biopsy at Week 16 (4 weeks following TX200-TR101 infusion).
- 5. From the day of TX200-TR101 infusion through to Week 84. Incidence and severity of chronic graft dysfunction, as measured by eGFR. Incidence and severity of chronic graft dysfunction, as measured by the Banff criteria for chronic rejection including the Banff lesion score i-IFTA. Incidence of graft loss due to rejection. Incidence and (semi-quantitative) intensity of de novo DSA.
研究者
Sangamo Patient Advocacy
Scientific
Sangamo Therapeutics France
研究点 (4)
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