NCT07253259招募中1 期
A Clinical Study Evaluating the Safety and Efficacy of GT729 Universal Cell Injection in the Treatment of Refractory or Relapsed Chronic Graft-versus-host Disease (cGVHD)
Grit Biotechnology1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年12月18日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The goal of this clinical study is to evaluate the safety and efficacy of GT729 universal cell injection in the treatment of refractory or relapsed chronic graft-versus-host disease (cGVHD).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants or their legal representatives voluntarily sign a written informed consent form, are willing and able to comply with the procedures of this study.
- •Aged 18 to 65 years old (inclusive) when signing the informed consent, regardless of gender.
- •Participants must meet the following criteria:
- •The subjects are allogeneic hematopoietic stem cell transplantation (alloHSCT) recipients with active chronic graft-versus-host disease (active cGVHD) requiring systemic immunosuppressive therapy.
- •The subjects are patients with refractory or relapsed active cGVHD after receiving at least two lines of systemic treatment.
- •The laboratory test results during the screening period must meet the following criteria (except for indicators related to the study disease):
- •Neutrophil count ≥ 1.0×10⁹/L;
- •Hemoglobin ≥ 80g/L; Platelet count ≥ 30×10⁹/L;
- •Alanine transaminase ≤ 3×upper limit of normal (ULN); Aspartate transaminase ≤ 3×ULN; Total bilirubin (TBIL) < 2×ULN;
- •Creatinine clearance rate ≥ 30 mL/min.
- •Women of childbearing age must:
- •At the time of screening, as confirmed by the investigator, the result of the serum β-human chorionic gonadotropin (β-hCG) pregnancy test is negative.
排除标准
- •Evidence of recurrence of underlying malignant tumors or post-transplant lymphoproliferative disorder (PTLD) at the time of screening
- •Having a history of severe hypersensitivity or allergies
- •Suffering from the following heart diseases:
- •New York Heart Association (NYHA) Class III or IV congestive heart failure;
- •A myocardial infarction occurred or coronary artery bypass surgery was performed within 6 months before the screening period.
- •Participants with clinically significant bleeding symptoms or a clear bleeding tendency within the 6 months prior to screening;
- •Participants with severe underlying medical conditions at the time of screening;
- •Participants who have undergone major surgery within 8 weeks prior to screening or are scheduled to undergo surgery during the study period;
- •History of organ transplantation;
- •According to the investigator's judgment, there are circumstances that would prevent the participant from completing the entire trial, confuse the trial results, or make participation in the trial not in the best interest of the participant.
研究组 & 干预措施
GT729 Injection treatment group
Experimental
GT729 Injection
干预措施: GT729 Injection (Biological)
结局指标
主要结局
Incidence of adverse events
时间窗: From infusion to the end of the treatment at 24 months
Incidence of adverse events per NCI-CTCAE version 5.0
Proportion of participants experiencing dose limiting toxicity
时间窗: 28 days
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
次要结局
- Overall response rate (ORR)(Up to 6 months post infusion)
研究者
研究点 (1)
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