[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cd7-t-alllbl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cd7-t-alllbl":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100640207","phase-1-single-arm-open-label-dose-escalating-phase-i-clinical-study-of-pa3-17-injection-in-children-and-adolescents-with-relapsedrefractory-t-lymphoblastic-leukemialymphoma-100640207",false,"NCT07623681","Single-arm, Open-label, Dose-escalating Phase I Clinical Study of PA3-17 Injection in Children and Adolescents With Relapsed\u002FRefractory T-lymphoblastic Leukemia\u002FLymphoma","R\u002FR T-ALL\u002FLBL","Inclusion Criteria:\n\n* (1) Aged from 3 to 18 years (inclusive), with no restriction on gender. (2) Expected survival time ≥ 3 months. (3) At screening, Karnofsky Performance Status score (for subjects aged ≥ 16 years) or Lansky Performance Score (for subjects aged \\\u003C 16 years) \\> 60 points (see Appendix 4).\n\n  (4) Diagnosed with T-ALL or T-LBL (including ETP-ALL and ETP-LBL) by local laboratories based on the classification criteria of WHO Classification of Haematolymphoid Tumours, 5th Edition: Lymphoid Neoplasms, confirmed via MICM classification (morphology, immunology, cytogenetics and molecular genetics), and\u002For pathological and imaging examinations.\n\nFor subjects diagnosed with T-LBL: bone marrow smear shows blasts between 5% (inclusive) and 20% (exclusive), or focal infiltration is observed on bone marrow biopsy indicating bone marrow involvement of T-LBL.\n\n(5) Subjects with relapsed or refractory disease after failure of standard treatment or without available effective treatment options:\n\n① Refractory disease: Failure to achieve remission after completion of at least 2 cycles of standard induction chemotherapy\\*.\n\n② Relapsed disease: New extramedullary lesions or bone marrow recurrence occurring in subjects who have achieved complete remission (CR).\n\nEarly relapse (\\\u003C 12 months) after complete remission; Late relapse (≥ 12 months) after complete remission with no response to one cycle of standard induction chemotherapy\\*.\n\nDefinition of bone marrow recurrence: If the percentage of blasts\u002Fimmature lymphocytes in bone marrow smear is ≥ 5% and \\\u003C 20%, evidence of molecular recurrence is required. In the absence of molecular recurrence evidence, at least two consecutive test results (both ≥ 5%) are required.\n\n* Failure to achieve remission after treatment with two or more lines of chemotherapy regimens\\*.\n\n  * Two or more episodes of relapse.\n\n    * Relapse after hematopoietic stem cell transplantation. \\* Remission criteria: CR and CRi for T-ALL; CR and PR for T-LBL. (6) At screening: ① Abnormal tumor cells are detected in bone marrow and\u002For peripheral blood by multi-color flow cytometry, regardless of the presence or absence of extramedullary lesions on imaging. Abnormal tumor cells in bone marrow must be CD7-positive; abnormal tumor cells in peripheral blood must be CD7-positive, CD4-negative and CD8-negative.\n\n      * No abnormal tumor cells are detected in bone marrow and\u002For peripheral blood by multi-color flow cytometry, and imaging shows only extramedullary lesions (e.g. lymphadenopathy). Immunohistochemistry of lesion specimens must confirm CD7 positivity with a CD7 positive rate ≥ 70%.\n\n        (7) For subjects with only extramedullary lesions: lesions shall be evaluable (by PET-CT) or measurable (by contrast-enhanced CT) per the 2014 Lugano Criteria for efficacy assessment specified in Appendix 5.\n\n        (8) Liver, renal, cardiac and pulmonary function shall meet the following criteria:\n\n        ① Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN. If ALT\u002FAST elevation is judged by the investigator to be caused by the underlying disease (e.g. liver infiltration or biliary obstruction), the upper limit may be extended to ≤ 5 × ULN. For subjects diagnosed with Gilbert's syndrome, total bilirubin ≤ 3.0 × ULN with direct bilirubin ≤ 1.5 × ULN.\n      * Creatinine ≤ 1.5 × ULN.\n* Left ventricular ejection fraction (LVEF) ≥ 45%. ④ Oxygen saturation \\> 91%. (9) The subject and\u002For legal guardian fully understands this trial, has signed the informed consent form, and is willing and able to comply with scheduled visits, treatment regimens, laboratory tests and all other study requirements specified in the study schedule.\n\nExclusion Criteria:\n\n* (1) Patients judged by the investigator to require long-term use of immunosuppressants at screening.\n\n  (2) Cerebrovascular accident or seizure occurring within 6 months prior to signing the informed consent form.\n\n  (3) Uncontrolled graft-versus-host disease (GvHD) or ongoing requirement for systemic treatment for GvHD.\n\n  (4) History of other malignancies (other than T-ALL\u002FLBL) within 5 years prior to screening, except for cured carcinoma in situ.\n\n  (5) Subjects with positive hepatitis B surface antigen (HBsAg) and abnormal peripheral blood hepatitis B virus (HBV) DNA titer; positive hepatitis B core antibody (HBcAb) with abnormal peripheral blood HBV DNA titer; positive hepatitis C virus (HCV) antibody coupled with positive peripheral blood HCV RNA; positive human immunodeficiency virus (HIV) antibody; positive cytomegalovirus (CMV) DNA; positive syphilis serology; positive Epstein-Barr virus (EBV) DNA.\n\n  (6) Severe cardiac diseases, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] Class ≥ III), and severe arrhythmia.\n\n  (7) Unstable systemic diseases as assessed by the investigator, including but not limited to severe hepatic, renal or metabolic diseases requiring medical treatment.\n\n  (8) Presence of chronic progressive neurological diseases. (9) Patients with unresolved acute toxicities from prior treatments. (10) Active or uncontrolled infections requiring systemic therapy (excluding mild genitourinary tract infections and upper respiratory tract infections).\n\n  (11) Female subjects of childbearing potential who plan to become pregnant within 2 years after cell infusion; male subjects whose partners plan to become pregnant within 2 years after cell infusion.\n\n  (12) Subjects who have received CAR-T therapy or other genetically modified cell therapies prior to screening.\n\n  (13) Participation in another clinical trial within 1 month prior to screening (calculated from the last administration of unapproved investigational products).\n\n  (14) Evidence of central nervous system (CNS) involvement identified at screening.\n\n  (15) Any other conditions deemed ineligible for enrollment by the investigator.","ALL","3 Years","18 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a phase I, open-label, dose-escalation clinical trial. The primary objectives are to assess the safety of PA3-17 injection in pediatric and adolescent participants with relapsed\u002Frefractory T-lymphoblastic leukemia\u002Flymphoma, and determine the recommended phase II dose of PA3-17 injection for this patient population.\n\nSecondary objectives include evaluating the pharmacokinetics\u002Fpharmacodynamics, preliminarily assessing clinical efficacy, and evaluating the immunogenicity of the injection.",[27],"CD7+ T-ALL\u002FLBL","NOT_YET_RECRUITING","2026-05-28",{"date":31,"type":32},"2026-06-03","ACTUAL",{"date":34,"type":21},"2026-06-10",{"date":36,"type":21},"2028-07-30",{"name":38,"class":39},"PersonGen BioTherapeutics (Suzhou) Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":40},"100614507","phase-1-to-observe-the-cd7-targeted-car-t-therapy-in-the-treatment-of-mrd-positive-t-alllbl-post-allo-hsct-100614507","NCT07280494","To Observe the CD7-targeted CAR-T Therapy in the Treatment of MRD Positive T-ALL\u002FLBL Post Allo-HSCT","An Open-label, Clinical Study of CD7-targeted CAR-T Cells for the Treatment of Measurable Residual Disease of T-lymphoblastic Leukaemia\u002FLymphoma Post Allogeneic Stem Cell Transplantation","S101MRD","Inclusion Criteria:\n\n* (1) The subject or the legal guardian understands and voluntarily signs the informed consent form (ICF).\n\n  (2) Male or female, age ≥ 3 years at the time of signing the informed consent form.\n\n  (3) Expected survival period of no less than 12 weeks. (4) ECOG performance score of 0-2 at the time of signing the ICF. (5) Confirmed as relapsed\u002Frefractory T-cell leukemia or lymphoma at the time of signing the ICF, meeting the following criteria:\n  1. Bone marrow morphology examination at screening shows the proportion of primitive immature lymphocytes in the bone marrow \\\u003C 5%, and positive for minimal residual disease of leukemia\u002Flymphoma determined by flow cytometry.\n  2. Tumor cells in the bone marrow or peripheral blood are CD7 positive as detected by flow cytometry.\n\n     (6) Major organ functions must meet the following requirements:\n\n  \u003C!-- -->\n\n  1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5× upper limit of normal (ULN).\n  2. Total bilirubin ≤ 2× ULN.\n  3. For adult subjects, the serum creatinine clearance rate ≥ 60 mL\u002Fmin (Cockcroft-Gault formula) or serum creatinine ≤ 1.5× ULN; for children, the serum creatinine should be no more than 0.8 mg\u002FdL for 2 to 6 years old, 1.0 mg\u002FdL for 6 to 10 years old, 1.2 mg\u002FdL for 10 to 13 years old, 1.5 mg\u002FdL for 13 to 16 years old males, and 1.4 mg\u002FdL for females over 13 years old; for males over 16 years old, it should be no more than 1.7 mg\u002FdL.\n  4. If the above organ function abnormalities are caused by infiltration of the primary disease, the decision on whether to include the subject in the study is made by the investigator.\n\n     (7) Blood oxygen saturation \\> 92%. (8) Male subjects with reproductive capacity and female subjects of childbearing age must agree to use effective contraceptive measures from the time of signing the informed consent form until 2 years after the use of the study drug. Female subjects of childbearing age include premenopausal women and women within 2 years after menopause. The blood pregnancy test of female subjects of childbearing age at screening must be negative.\n\n     Exclusion Criteria:\n* Subjects with any of the following conditions will not be eligible for inclusion in this study.\n\n  1. A history of CNS diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, and neuropathy. A history of diseases without related neurological symptoms before screening, such as lacunar infarction, etc., will be excluded at the discretion of the investigator.\n  2. Any uncontrolled active infection within 4 weeks before signing the ICF or before apheresis.\n  3. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening and peripheral blood hepatitis B virus (HBV) DNA above the detection limit, positive hepatitis C virus (HCV) antibody and positive HCV RNA, positive human immunodeficiency virus (HIV) antibody, cytomegalovirus (CMV) DNA above the detection limit, Epstein-Barr virus (EBV) DNA above the detection limit, and both specific and non-specific antibodies for Treponema pallidum positive need to be excluded.\n  4. Clinically significant cardiovascular diseases, including any of the following:\n\n     1. Corrected QTc interval ≥ 480 ms (QTc interval calculated by the Fridericia formula);\n     2. New York Heart Association (NYHA) class II or higher heart failure;\n     3. Unstable angina or acute myocardial infarction within 6 months before signing the ICF;\n     4. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n     5. Uncontrolled hypertension (judged by the investigator based on the individual condition of the subject);\n     6. Clinically significant or requiring antiarrhythmic treatment arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, and complete left bundle branch block, etc.).\n  5. Allergy to any component of the drugs to be used in this study.\n  6. Received any investigational drug treatment or other systemic anti-tumor treatment within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is judged more appropriate by the investigator), except for bridging chemotherapy due to large tumor burden or rapid disease progression.\n  7. Received extensive radiotherapy within 4 weeks before signing the ICF, except for local radiotherapy for symptom relief of non-target lesions during the study period.\n  8. Received systemic corticosteroids (dose equivalent to or higher than 10 mg\u002Fday of prednisone) or other immunosuppressive drugs within 3 days before apheresis or during the study period, except for the following situations:\n\n     1. Intranasal, inhaled, topical steroids or local steroid injections (such as intra-articular injections);\n     2. Systemic corticosteroids at a dose not exceeding 10 mg\u002Fday of prednisone or its equivalent physiological dose;\n     3. Steroids as prophylactic treatment for allergic reactions (such as pre-treatment before computed tomography \\[CT\\]);\n     4. For the treatment of adverse reactions after reinfusion.\n  9. Received major surgery within 4 weeks before signing the ICF (routine biopsy surgeries excluded), or expected to undergo major surgery during the study period.\n  10. Had active tuberculosis infection within 1 year before signing the ICF (except for subjects with active tuberculosis infection more than 1 year ago and judged by the investigator to have no evidence of active tuberculosis at present).\n  11. Received live attenuated vaccines within 4 weeks before signing the ICF or planned to receive live attenuated vaccines during the screening period.\n  12. The investigator believes that the subject's complications or other conditions may affect compliance with the protocol or are not suitable for participation in this study.\n  13. Pregnant or lactating.","80 Years",{"count":51,"type":21},18,[24],"To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of T-lymphoblastic leukaemia\u002Flymphoma with postive measurable residual disease positive post allogeneic stem cell transplantation",[27],[56,57,58,59,60],"CD7","CAR T cell therapy","T-lymphoblastic leukemia\u002Flymphoma","measurable residual disease","allogeneic hematopoietic stem cell transplantation","RECRUITING","2025-12-01",{"date":64,"type":32},"2025-12-12",{"date":66,"type":32},"2025-08-18",{"date":68,"type":21},"2027-12-31",{"name":70,"class":71},"Peking University People's Hospital","OTHER"]