[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cd7-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cd7-lymphoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100601961","phase-1-cd7-car-t-combined-with-autologous-hematopoietic-stem-cell-transplantation-100601961",false,"NCT07117305","CD7 CAR-T Combined With Autologous Hematopoietic Stem Cell Transplantation","A Clinical Investigation Into the Safety and Efficacy of CD7 Chimeric Antigen Receptor T-cell (CAR-T) Therapy in Combination With Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Relapsed\u002FRefractory T-cell Lymphoma","Inclusion Criteria:\n\n1. With the patient's explicit consent and after signing the informed consent form, the patient is willing and capable of complying with the planned visits, research treatments, laboratory tests and other trial procedures;\n2. Age range: 14 to 65 years old. Both men and women are eligible;\n3. All types of CD7+ T-cell non-Hodgkin's lymphomas (except T-lymphoblastic lymphoma) diagnosed according to the World Health Organization's classification of hematopoietic and lymphoid tissue tumors (2022);\n4. For patients with T-cell lymphoma who are refractory to the first-line chemotherapy regimen or who experience recurrence and resistance after at least the second-line chemotherapy regimen. The following criteria must be met: a. For those patients who had only received first-line treatment previously, if they did not achieve PR after at least 4 cycles of the first-line regimen, or if they did not achieve CR after at least 6 cycles of the first-line regimen; b. Those who experienced recurrence in the early stage (\\\u003C 12 months) after complete remission; or those who experienced recurrence in the late stage (≥ 12 months) and did not achieve remission after one course of standard induction chemotherapy; c. Those who have not achieved remission after treatment with second-line or more chemotherapy regimens;\n5. During the enrollment screening process, the subjects were confirmed to have CD7+ (with CD7 expression ≥ 10%) through pathological histology and\u002For cytology;\n6. Having measurable or evaluable lesions: The target lesion is defined as a lesion within lymph nodes with a long diameter of ≥ 15mm, or an extranodal lesion larger than 10mm (in accordance with the Lugano 2014 criteria); Lesions that have received prior radiotherapy are considered measurable only if there is a clear progression after completing radiotherapy; or PET-positive lesions determined according to the Lugano criteria;\n7. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 to 2, and the estimated survival period is greater than 3 months;\n8. Having appropriate organ functions: a. The levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be ≤ 3 times the upper limit of normal (ULN). If the abnormality of ALT and AST is judged to be caused by the disease (such as liver infiltration or bile duct obstruction), the thresholds can be relaxed to ≤ 5 times ULN; b. Total serum bilirubin ≤ 2 times ULN, except in cases where Gilbert syndrome is present; patients with Gilbert syndrome whose total bilirubin is ≤ 3 times ULN and direct bilirubin is ≤ 1.5 times ULN can be included; c. Serum creatinine ≤ 1.5 times the upper limit of normal, or creatinine clearance rate ≥ 60 mL\u002Fmin; d. The international normalized ratio (INR) is no more than 1.5 times the upper limit of normal (ULN), and the activated partial thromboplastin time (aPTT) is no more than 1.5 times the ULN; e. Having the lowest level of lung reserve, defined as ≤ grade 1 dyspnea (CTCAE v5.0) and a blood oxygen saturation of ≥ 92% in the absence of oxygen supplementation; f. Left ventricular ejection fraction in echocardiography is ≥ 50%; no clinically significant abnormal electrocardiogram findings; no clinically significant pericardial effusion or pleural effusion.\n9. Female participants of childbearing potential must have negative blood\u002Furine pregnancy tests within 7 days prior to infusion. All sexually active males and females with reproductive capacity must agree to use highly effective contraception throughout the study and for at least 2 years after administration of the investigational treatment.\n\nExclusion Criteria:\n\n1. Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) \\\u003C50%；\n2. Documented history of severe pulmonary impairment；\n3. History of organ transplantation or active graft-versus-host disease (GVHD);\n4. Concurrent other progressive malignancies;\n5. Uncontrolled severe infections;\n6. Severe autoimmune diseases or primary immunodeficiency disorders;\n7. Positive for any of the following: Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg); Hepatitis B e antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab) with HBV-DNA levels above the upper limit of normal (ULN); Hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA; Human immunodeficiency virus antibody (HIV-Ab); Treponema pallidum antibody (TP-Ab); Cytomegalovirus (CMV) DNA above ULN; Epstein-Barr virus (EBV) DNA above ULN；\n8. History of severe hypersensitivity to biological products (including antibiotics);\n9. Pre-existing central nervous system disorders, including but not limited to:\n\n   Uncontrolled epilepsy；Cerebral ischemia\u002Fhemorrhage；Dementia；Cerebellar disorders；\n10. Previous recipients of autologous or allogeneic hematopoietic stem cell transplantation;\n11. Any other severe physical or psychiatric conditions or significant laboratory abnormalities that may: Increase study participation risks；Interfere with study results interpretation; Be deemed by investigators to render the patient unsuitable for study participation;\n12. Presence of lymphoma-related clinical emergencies requiring immediate intervention at screening due to tumor mass obstruction or compression (e.g., intestinal obstruction, vascular compression, etc.).","ALL","14 Years","65 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a single-arm, open-label, phase I\u002FII clinical trial initiated by investigators to evaluate the safety, tolerability, and preliminary efficacy of CD7-targeted chimeric antigen receptor T cells (CD7 CAR-T) combined with autologous stem cell transplantation (ASCT) in patients with relapsed or refractory CD7-positive T-cell lymphomas. Phase I adopts a standard 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Phase II expands at the RP2D to further assess efficacy. The study includes lymphodepletion chemotherapy, ASCT, and sequential infusion of CD7 CAR-T cells. The primary objectives include: (1) Evaluate safety\u002Ftolerability of CD7 CAR-T + auto-HSCT in relapsed or refractory CD7-positive T-cell lymphomas. (2) Determine MTD and RP2D. The secondary objectives include: (1) Assess efficacy (overall response rate, complete response, duration of response, progression-free survival and overall survival. (2)Characterize PK\u002FPD profiles. (3)Investigate anti-tumor mechanisms.",[28,29],"CD7+ Lymphoma","T Cell Lymphoma","NOT_YET_RECRUITING","2025-08-04",{"date":33,"type":34},"2025-08-12","ACTUAL",{"date":36,"type":21},"2025-09-01",{"date":38,"type":21},"2027-12-01",{"name":40,"class":41},"Zhengzhou University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100593625","cd7-car-t-cell-therapy-targeting-cd7-positive-relapsedrefractory-t-cell-lymphomaacute-leukemia-100593625","NCT07008872","CD7 CAR-T Cell Therapy Targeting CD7-positive Relapsed\u002FRefractory T Cell Lymphoma\u002FAcute Leukemia","Clinical Study on the Efficacy and Safety of CD7 CAR-T Cell Therapy Targeting CD7-positive Relapsed\u002FRefractory T Cell Lymphoma\u002FAcute Leukemia","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1. Subjects diagnosed with relapsed\u002Frefractory lymphoma\u002Fleukemia:\n\n   1. Relapsed\u002Frefractory T-cell malignant lymphoma: patients who have not remission and recurrence after at least 2 courses of standardized second-line or above treatment (including hematopoietic stem cell transplantation).\n   2. Relapsed\u002Frefractory T-cell acute lymphocytic or myeloid leukemia meeting any of the following criteria:\n\n   i) Relapse: After achieving complete remission with a standard treatment regimen (including hematopoietic stem cell transplantation), blasts appear in peripheral blood or bone marrow (proportion\\>5%), or extramedullary diseases occur; ii) Refractory: No complete remission after at least two courses of standard induction therapy.\n2. Bone marrow flow cytometry detected tumor cells as CD7 and\u002For extramedullary lesions with a clear diagnosis of CD7 by pathological immunohistochemistry at the time of enrollment screening;\n3. If tumor cells are detected in peripheral blood during enrollment screening, flow cytometry must be used to detect that the immunophenotype of tumor cells on the surface of tumor cells is both negative for CD4 and CD8. If the immunophenotype on the surface of peripheral blood tumor cells is not CD4 and CD8 negative, the proportion of peripheral blood tumor cells must be ≤1%;\n4. Expected survival greater than 3 months from the date of signing the informed consent form;\n5. Subjects with a performance status of 0\\~2 in the Eastern Cooperative Oncology Group (ECOG) score;\n6. 14 years old≤ age ≤ 75 years old, male or female;\n7. HGB at least ≥70g\u002FL, blood transfusion is available;\n8. Liver and kidney function, heart and lung function meet the following requirements:\n\n   1. creatinine ≤1.5×ULN;\n   2. left ventricular ejection fraction ≥50%;\n   3. Oxygen saturation \\>90%;\n   4. Total bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN;\n9. Subject or guardian understands and signs the informed consent form.\n\nExclusion Criteria:\n\n1. One of the following cardiac criteria occurs: atrial fibrillation; Myocardial infarction within the past 12 months; Prolonged QT syndrome or secondary QT Extension, to be determined by the researcher. Echocardiography with LVSF\\\u003C30% or LVEF\\\u003C50%; Clinically significant pericardial effusion; Heart function Incomplete NYHA III or IV (confirmed by echocardiography within 12 months after treatment);\n2. Active GVHD;\n3. Have a history of severe pulmonary dysfunction;\n4. Merge other advanced malignant tumors;\n5. Combination of severe or persistent infections that cannot be effectively controlled;\n6. Combination of severe autoimmune diseases or congenital immunodeficiency;\n7. Active hepatitis (hepatitis B virus deoxyribonucleic acid \\[HBV-DNA ≥ 500 IU\u002Fml and abnormal liver function\\] or anti hepatitis C virus Positive for HCV Ab, HCV-RNA above the detection limit of the analytical method, and abnormal liver function;\n8. Human immunodeficiency virus (HIV) infection or syphilis infection;\n9. Have a history of severe allergies to biological products (including antibiotics);\n10. There are central nervous system disorders, such as uncontrolled epilepsy, cerebral ischemia\u002Fhemorrhage, dementia, cerebellar diseases, etc;\n11. Female patients who are pregnant or breastfeeding, or have a pregnancy plan within 12 months;\n12. The researcher believes that there may be situations that increase the risk to the subjects or interfere with the test results.","75 Years",{"count":52,"type":21},40,[54],"NA","CD7 molecules are thought to be associated with disease aggressiveness, drug resistance, and poor prognosis. Intensive chemotherapy, immunotherapy, hematopoietic stem cell transplantation (HSCT) and other treatment regimens have achieved remarkable results in the treatment of hematologic malignant diseases. Nevertheless, patients with hematologic malignancies may still tolerate acquired therapy during the above treatments, and molecular targeted immunotherapy provides a safe, efficient and specific treatment for such patients The scheme has attracted more and more researchers' attention. The use of CD7 molecules as a new target for molecularly targeted anti-tumor therapy may provide a new research direction for the treatment of CD7 relapsed\u002Frefractory hematologic malignancies.",[28,57],"CD7+ Acute Leukemia",[59],"CD7 CART, AL, lymphoma","2025-06-04",{"date":62,"type":34},"2025-06-06",{"date":64,"type":21},"2025-06-01",{"date":66,"type":21},"2027-05-31",{"name":68,"class":41},"Qi deng"]