NCT06462365招募中1 期
Phase I, First in Human, Open Label Study to Evaluate Safety and Tolerability of TRX103 Cells in Subjects With Hematological Malignancies Undergoing HLA-mismatched Related or Unrelated Hematopoietic Stem Cell Transplantation (HSCT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Tr1X, Inc.
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Safety and tolerability of TRX103 cell infusion through incidence of Adverse events.
研究概览
简要总结
The purpose of this Phase 1, first in human open-label study is to assess the safety and tolerability of TRX-103 in patients with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT). It is anticipated that up to 36 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time post HSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •Subjects with one of the following hematologic malignancies: Acute Lymphoblastic Leukemia (B- or T-ALL), Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
- •Males and Females Age ≥ 18 years.
- •Weight of ≥ 35 Kg.
- •Karnofsky performance status ≥ 70 %.
- •Available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation.
- •Subjects must otherwise fulfill institutional criteria for eligibility to undergo allogeneic stem cell transplantation.
- •Absence of uncontrolled bacterial, viral or fungal infection at time of enrollment.
- •Have adequate organ function.
- •Subjects > 65-year-old receiving MAC conditioning will only be eligible if they have a HSCT-comorbidity index score <
- •Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.
排除标准
- •Prior allogeneic bone marrow, peripheral blood, or cord blood HSCT.
- •Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.
- •HIV positive.
- •Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
- •Positive hepatitis-C antibody with positive Recombinant Immunoblot Assay (RIBA) or PCR unless the subject has received curative anti-viral treatment and confirmed negative viral load by PCR.
- •Received another investigational agent for treatment of disease understudy within 28 days (or 5 half-lives, whichever is shorter) of conditioning and/or have not recovered from treatment related toxicities.
- •Subjects with a previous history of Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS) who are not good candidates for treatment with sirolimus.
- •Subjects that are pregnant, breast feeding or aim to become pregnant during the study period. (Subjects must agree to use a highly effective method of contraception).
- •Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results.
研究组 & 干预措施
TRX-103
Experimental
TRX-103 will be infused on time post hematopoietic stem cell transplant (HSCT).
干预措施: TRX103 (Biological)
结局指标
主要结局
Safety and tolerability of TRX103 cell infusion through incidence of Adverse events.
时间窗: Up to a year
Safety of TRX103 determined by stem cell engraftment and donor chimerism after HSCT measured by absolute neutrophil counts and percent donor chimerism.
时间窗: Up to day 42
Safety of TRX103 determined by negative Replication Competent Lentivirus (RCL).
时间窗: At 3-month, 6-month, and 1-year.
次要结局
- Incidence of Grade III-IV acute GvHD (aGvHD).(Day 0 to Day +100 day)
- Incidence of Grade II-IV acute GvHD (aGvHD).(Day 0 to Day +100 day)
- Overall survival at Day +365.(Up to a year)
- Incidence and severity of chronic GvHD (cGvHD)(Day +100 through Day +365)
研究者
研究点 (5)
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