2025-523139-21-00撤回2 期
PHASE I/IIa CLINICAL TRIAL FOR THE TREATMENT OF GRAFT VERSUS HOST DISEASE WITH A NEW GENERATION OF MESENCHYMAL STROMAL CELLS ECTOPICALLY EXPRESSING CXCR4 AND IL-10 IN STEROID-REFRACTORY AND INTOLERANT OR RUXOLITINIB-REFRACTORY PATIENTS
Fundacion Instituto De Investigacion Sanitaria De Navarra5 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年1月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Safety: • Serious Adverse Reactions after sequential infusions of the study drug, regardless of the number of doses the patient has received and during the entire follow-up period. • Serious Unexpected Serious Adverse Reactions at the time of infusion or during follow-up
研究概览
简要总结
To analyze the safety and tolerability of the administration of allogeneic adipose tissue MSCs genetically modified to ectopically express CXCR4 and IL10 for the treatment of patients who have developed acute GVHD refractory to corticosteroids and ruxolitinib or that are not eligible to receive ruxolitinib
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Have undergone alloHSCT from any donor source (matched unrelated donor, sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood
- •Recipients of nonmyeloablative, myeloablative, and reduced intensity conditioning are eligible.
- •Male or female subjects between 18 and 75 years of age.
- •Clinically diagnosed grades II to IV acute GVHD as per standard criteria (Annex 2) occurring after alloHSCT. Biopsy of involved organs with aGVHD is encouraged but not required for study screening
- •Confirmed diagnosis of steroid AND ruxolitinib relapse or refractory aGVHD or non-eligible to ruxolitinib, defined as: a) Progression of GVHD compared with baseline after at least 7 days of treatment with ruxolitinib, based either on objective increase in stage/grade, or new organ involvement. b) Lack of improvement in GVHD (partial response or better) compared with baseline after at least 14 days of treatment with ruxolitinib c) Loss of response to ruxolitinib, defined as objective worsening of GVHD determined by increase in stage, grade, or new organ involvement at any time after initial improvement. GVHD manifestations that persist without improvement in patients who had a grade ≥3 treatment-emergent and ruxolitinib-attributed adverse event that did not resolve within 7 days of discontinuing ruxolitinib would serve as a clinical indication for additional treatment. Patients considered non-eligible to ruxolitinib should be steroid refractory, defined as: progression of GVHD compared with baseline after 3 days of corticosteroid treatment, a lack of response after 7 days or treatment failure during glucocorticoid taper. For these patients, inclusion criteria might be: d) Severe thrombocytopenia < 20000/mm3 or neutropenia < 500/mm3 e) Any other clinical condition that makes the patient non eligible to ruxolitinib treatment at the investigator criteria
- •Female subjects who are: Postmenopausal for at least 1 year before signing of the informed consent, OR surgically sterile OR if they are aged 18 years or greater and not postmenopausal or surgically sterilized must use a highly effective method of contraception during the study, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.
排除标准
- •Hematological disease not controlled by the transplant or in progression at the time of inclusion.
- •Positive PCR for SARS COV2 within 10 days prior to mesenchymal cells infusion
- •If female, the subject is pregnant, lactating or breastfeeding, or intending to become pregnant before, during, or within 18 weeks after participating in this study, or intending to donate ova during such time period
- •Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, coagulation, immunological, endocrine/metabolic, neurologic, or other medical disorder not related to the subject's primary disease that, in the opinion of the investigator, would confound the study results or compromise subject safety.
- •Clinically active systemic infection during screening
- •Patients who are currently participating or have completed their participation in a clinical trial in a period of less than 3 months
- •Patients who have participated in an advanced therapies clinical trial (cell therapy, gene therapy or tissue engineering) at any previous time.
- •Chronic hepatitis B (hepatitis B surface antigen [HBsAg] positive) or hepatitis C infection (evident by active viral replication by polymerase chain reaction [PCR] if hepatitis C virus antibody positive). Hepatitis B core antibody (HBcAb) positive (HBcAb+) and negative for hepatitis B surface antigen (HBsAg-) may be enrolled if viral DNA is undetectable
- •History of human immunodeficiency virus (HIV) positive test
研究组 & 干预措施
Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cells (MSC) ectopically expressing CXCR4 and IL10
Test
干预措施: Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cells (MSC) ectopically expressing CXCR4 and IL10 (Drug)
结局指标
主要结局
Safety: • Serious Adverse Reactions after sequential infusions of the study drug, regardless of the number of doses the patient has received and during the entire follow-up period. • Serious Unexpected Serious Adverse Reactions at the time of infusion or during follow-up
Safety: • Serious Adverse Reactions after sequential infusions of the study drug, regardless of the number of doses the patient has received and during the entire follow-up period. • Serious Unexpected Serious Adverse Reactions at the time of infusion or during follow-up
次要结局
- Efficacy The response will be analyzed through clinical and biological parameters
研究者
Sara Villar Fernández
Scientific
Fundacion Instituto De Investigacion Sanitaria De Navarra
研究点 (5)
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