NCT07345780尚未招募不适用
This Study is a Single-arm, Multicenter Investigator-Initiated Trial (IIT) Clinical Study. The Primary Objective is to Evaluate the Safety, Pharmacokinetic Characteristics, and Preliminary Efficacy of CAR-T Cells in Subjects With Relapsed/Refractory (r/r) CD7-positive Hematological Malignancies. The Study Plans to Enroll 20 Subjects, With the Actual Sample Size to be Determined Based on Real-world Occurrence.
Donghua Zhang1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2026年12月31日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study is a single-arm, multicenter Investigator-Initiated Trial (IIT) clinical study. The primary objective is to evaluate the safety, pharmacokinetic characteristics, and preliminary efficacy of CAR-T cells in subjects with relapsed/refractory (r/r) CD7-positive hematological malignancies. The study plans to enroll 20 subjects, with the actual sample size to be determined based on real-world occurrence.
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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatments required by the study protocol.
- •Aged 18-85 years (inclusive), gender not restricted. Subjects diagnosed according to WHO 2016 criteria with relapsed/refractory acute T-lymphoblastic leukemia/lymphoma (including early T-precursor lymphoblastic leukemia) who have failed standard treatment or lack effective treatment options, meeting any of the following criteria:a) Relapsed: Previously received at least two treatment regimens and achieved complete remission followed by confirmed disease recurrence, or achieved complete remission after stem cell transplantation followed by disease recurrence.b) Refractory: Previously received at least two treatment regimens and failed to achieve CR (for leukemia patients) or PR (for lymphoma patients) after the last treatment, or failed to achieve remission or experienced disease progression after stem cell transplantation.
- •Diagnosed with AML according to the 2016 WHO classification and meeting the diagnostic criteria for relapsed and refractory AML in the Chinese Guidelines for Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2017 Edition):a) Diagnostic criteria for relapsed AML: Reappearance of leukemic cells in peripheral blood after complete remission (CR), or >5% blasts in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary leukemic cell infiltration.b) Diagnostic criteria for refractory AML: Newly diagnosed cases failing to respond to standard treatment after 2 courses; Relapse within 12 months after CR following consolidation/intensification therapy; Relapse after 12 months but unresponsive to conventional chemotherapy; Two or more relapses; Persistent extramedullary leukemia.
- •Hematolymphoid malignancies confirmed by flow cytometry in bone marrow examination and/or by pathological immunohistochemistry in tumor tissue as CD7-positive at screening, with tumor positivity rate ≥70%.
- •Patients who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT) must have the ability to donate autologous mononuclear cells (hereinafter referred to as apheresis) or peripheral blood for CAR-T cell manufacturing. Peripheral blood smear at screening should show <30% tumor cells. For patients who have received allo-HSCT requiring autologous blood collection, peripheral blood smear at screening should also show <30% tumor cells; there is no such restriction if collecting donor blood.
- •Patients have recovered from the toxicity of previous treatments, i.e., CTCAE toxicity grade <2 (unless the abnormality is tumor-related or judged by the investigator to be stable with minimal impact on safety or efficacy).
- •ECOG performance status score 0-2 and life expectancy >3 months.
- •Appropriate organ function:
- •Alanine transaminase (ALT) and aspartate transaminase (AST) ≤3×upper limit of normal (ULN). For ALT and AST abnormalities judged by the investigator to be disease-related (e.g., liver infiltration or biliary obstruction), the limit may be extended to ≤5×ULN.
- •Total bilirubin ≤1.5×ULN. Serum creatinine ≤1.5×ULN, or creatinine clearance ≥60 mL/min. Hemoglobin ≥60 g/L or maintained at this level after transfusion. Room air oxygen saturation ≥92%. Left ventricular ejection fraction (LVEF) ≥45%. Patients failing to meet any of the above criteria will not be enrolled as subjects.
排除标准
- •History of malignancy other than T-cell hematological malignancies within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical treatment, and ductal carcinoma in situ of the breast after radical treatment.
- •Patients with clinically symptomatic central nervous system leukemia. Positive for hepatitis B surface antigen (HBsAg); positive for hepatitis B core antibody (HBcAb) with HBV DNA titer outside the normal reference range; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA; positive for syphilis.
- •History of severe allergies [severe allergy defined as grade 2 or higher allergic reaction with any of the following clinical manifestations: airway obstruction (rhinorrhea, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest] or known hypersensitivity to any active ingredients, excipients, murine products, or xenogeneic proteins contained in this study (including lymphodepletion regimens).
- •Severe heart disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (defined as: blood pressure not controlled despite ≥3 antihypertensive drugs (including diuretics) at maximum tolerated doses for >1 month after lifestyle modification, or requiring ≥4 antihypertensive drugs for effective control).
- •Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney, or metabolic diseases requiring medical treatment.
- •Previous organ transplantation or planned organ transplantation (except hematopoietic stem cell transplantation).
- •Acute or chronic graft-versus-host disease (GVHD) of any grade occurring 2 weeks after discontinuation of immunosuppressive therapy.
- •Hematopoietic stem cell transplantation within 6 months prior to screening. Active autoimmune or inflammatory neurological diseases (e.g., Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).
- •Tumor emergencies requiring urgent treatment at screening or prior to infusion (e.g., spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome).
- •Uncontrolled bacterial, fungal, viral, or other infections requiring antibiotic treatment.
- •Major surgery (except diagnostic procedures and biopsies) within 4 weeks prior to lymphodepletion or planned major surgery during the study, or incompletely healed surgical wounds prior to enrollment.
- •Live virus vaccination within 4 weeks prior to screening. Severe mental illness. History of alcoholism or substance abuse. Pregnant or lactating women, and female subjects planning pregnancy within 2 years after cell infusion or male subjects whose partners plan pregnancy within 2 years after their cell infusion.
- •Patients with contraindications to any study procedures or other medical conditions that may put them at unacceptable risk according to investigator judgment and/or clinical standards.
研究组 & 干预措施
Experimental:Experimental group
Experimental
干预措施: CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies (Drug)
结局指标
主要结局
Overall survival
时间窗: Time frame:1, 3,6,12,18, 24 months after tretment
次要结局
未报告次要终点
研究者
Donghua Zhang
professor
Tongji Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid TumorsNCT07327411Second Affiliated Hospital of Soochow University40
尚未招募
1 期
An Open-label, Single-arm, Prospective, Multicenter, Phase I/II Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Relapsed/Refractory Warm Antibody Autoimmune Hemolytic AnemiaNCT07324889Yihao Wang24
招募中
2 期
Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary AdenocarcinomaNCT07314216Hunan Cancer Hospital15
招募中
1 期
A Phase I Study of WTX212A Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid TumorsCancerNCT07269899Sun Yat-sen University12
招募中
2 期
Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell CarcinomaNCT07266493Shanghai Zhongshan Hospital26