NCT01649388撤回2 期
A Single-arm, Multi-center, Exploratory Safety and Efficacy Study of FCR001 Cell-based Therapy to Induce Donor-specific Tolerance in Previously Transplanted Recipients of a Kidney From a Living Donor, and Safety in FCR001 Donors
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Proportion of FCR recipients (FCR-R) who are free from immunosuppression (IS), without biopsy-proven acute rejection (BPAR), at 24 months post-FCR001 infusion
研究概览
简要总结
An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.
详细描述
The purpose of this study is to assess the safety, tolerability, preliminary efficacy, and overall benefit of FCR001 cell therapy in previously transplanted recipients of a kidney from a living donor.
FCR001 is a novel, cryopreserved allogeneic somatic cell therapy, derived from mobilized peripheral blood mononuclear cells from the same donor as the allograft, and containing hematopoietic progenitor cells, facilitating cells, and αβ T cells. The rationale is to establish durable chimerism and donor-specific tolerance in the recipient enabling freedom from chronic immunosuppression (IS) and its associated toxicities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient age ≥18 years old.
- •Donor age ≥18 and ≤60 years old at the time of signing informed consent.
- •Recipient of a first kidney transplant from a living donor 3-12 months prior to signing informed consent.
- •Stable renal allograft function ≥60 mL/min/1.73m^2 prior to screening (defined as <25% decrease in eGFR (by Modification of Diet in Renal Disease formula [MDRD4]) between the last 2 consecutive visits and per investigator judgment).
- •Donor between 3 weeks and 12 months after kidney donation, willing to undergo mobilization, apheresis, and 12-month safety follow-up.
- •Main Exclusion Criteria (Recipient and Donor):
- •Donor/recipient crossmatch positive at time of living donor kidney transplantation.
- •Recipient or donor with use of other investigational drugs within 30 days (or within 5 drug half-lives) of signing informed consent.
- •Recipient or donor with history of hypersensitivity to any of the study drugs or drugs of similar chemical classes.
- •Recipient and donor who are identical twins.
- •Pregnant or nursing (lactating) woman.
- •Recipient or donor with history of malignancy or premalignant syndrome (e.g., myelodysplastic syndrome, monoclonal gammopathy of renal significance [MGRS], monoclonal gammopathy of unknown significant [MGUS]) of any organ system (other than localized excised non-melanomatous lesions of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •Recipient or donor with known bone marrow aplasia.
- •Main Exclusion Criteria (Recipient-Only):
- •Multi-organ or cell transplant recipient.
- •Blood type ABO incompatible with donor.
- •Positive donor-specific antibody (DSA) at any time pre- or post-transplant (to be confirmed within 30 days prior to FCR001 infusion).
- •Panel Reactive Antibodies (PRA) >80% at the time of living donor kidney transplantation.
- •Induction with alemtuzumab at the time of living donor kidney transplantation.
- •History of acute rejection (biopsy-proven or suspected and treated) or recurrent kidney disease following living donor kidney transplantation.
- •Findings consistent with acute rejection or recurrent disease on the Screening biopsy.
- •Demonstrated intolerance to maintenance immunosuppression with tacrolimus and MMF or MPS.
- •Being maintained on oral corticosteroids (prednisone >10 mg/day or equivalent).
- •Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). Recipients with history of HCV infection may participate if there is a documented history of treatment with an anti-HCV agent and either one (1) documented negative PCR at least three (3) months after last dose of treatment, or two (2) documented negative PCRs at least 2 weeks apart over a maximum of 4 weeks.
- •Positive for BKV, CMV, or EBV by PCR at screening.
- •Having any baseline condition requiring or anticipated to require chronic or intermittent use of systemic steroids or other IS (e.g., autoimmune disease, asthma) throughout the course of the study.
- •Having a body mass index (BMI) < 18 or > 35 kg/m^
- •Requiring systemic anticoagulation, (e.g., for hypercoagulation disorders, deep vein thrombosis, atrial fibrillation) that cannot be temporarily interrupted with would preclude renal biopsy.
- •Having contraindication to TBI according to local radiologist.
- •History of autologous or allogeneic hematopoietic progenitor or mesenchymal stem cell transplant prior to signing informed consent.
- •Main Exclusion Criteria (Donor-Only):
- •Biologically unrelated (i.e., no genetic relationship) female donor transplant to male recipient.
排除标准
- 未提供
结局指标
主要结局
Proportion of FCR recipients (FCR-R) who are free from immunosuppression (IS), without biopsy-proven acute rejection (BPAR), at 24 months post-FCR001 infusion
时间窗: From infusion to 24 months
次要结局
- Change in renal function (estimated Glomerular Filtration Rate [eGFR] by Modification of Diet in Renal Disease [MDRD4]) from baseline (Day 1, prior to FCR001 infusion) to Month 24 in FCR recipients(From Day 1 prior to infusion to 24 months)
- Renal allograft function (eGFR by MDRD4)(From infusion to 24 months and 60 months)
- Change in renal allograft function over time by MDRD4(From infusion to 24 months and 60 months)
- Renal allograft function (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula(From infusion to 24 months and 60 months)
- Change in renal allograft function over time by CKD-EPI(From infusion to 24 months and 60 months)
- Time to event for the composite of BPAR, renal graft loss, death, or lost to follow-up and each component(From infusion to 60 months)
- Incidence of composite endpoint of BPAR, renal graft loss, or death(From infusion to 12 months, 24 months and 60 months)
- Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study and/or regimen discontinuation(From informed consent to 12 months, 24 months and 60 months)
- Incidence of BK viremia, viruria, infection, and nephropathy(From informed consent to 12 months, 24 months and 60 months)
- Incidence of donor chimerism by visit(From infusion to 60 months)
- Incidence of acute and chronic GvHD(From infusion to 60 months)
- Incidence of engraftment syndrome(From infusion to 60 months)
- Incidence of recipient autologous apheresis product infusion(From infusion to 60 months)
- Renal graft survival for recipients transiently chimeric(From infusion to 60 months)
- Incidence of composite endpoint of BPAR, death, renal graft loss, or lost to follow-up in FCR-R who did not achieve durable chimerism or able to wean or remain off IS(From infusion to 60 months)
研究者
研究点 (6)
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