[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-cell-acute-lymphoblastic-leukemialymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-cell-acute-lymphoblastic-leukemialymphoma":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100587899","phase-1-anti-cd7-car-t-cells-in-relapsedrefractory-t-cell-acute-lymphoblastic-leukemia-or-lymphoma-100587899",false,"NCT06934382","Anti-CD7 CAR-T Cells in Relapsed\u002FRefractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma","A Phase 1 Study of Allogeneic Anti-CD7 CAR-T Cells (BEAM-201) in Relapsed\u002FRefractory T-cell Acute Lymphoblastic Leukemia (T-ALL) or T-cell Lymphoblastic Lymphoma (T-LLy)","24CT015","Patients must meet all the following criteria to be eligible for enrollment into the study:\n\n1. Patients (ages ≥ 18 years) or parent\u002Flegal guardians (for patients ages \\\u003C 18 years) must provide signed, written informed consent according to local IRB and institutional requirements.\n2. Ages 0 to 29 years.\n3. T-ALL\u002FT-LLy in second or greater relapse, first relapse post-transplant, or chemotherapy-refractory disease. Specifically:\n\n   1. Second or greater relapse or post-transplant relapse, defined as:\n\n      * BM with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease after second documented CR; OR\n      * Flow cytometric confirmation of relapsed T-ALL of at least 0.1% after second CR documented to have been MRD negative \\\u003C 0.1%; OR\n      * Any detectable relapsed disease post-allogeneic HSCT with flow cytometric confirmation of T-ALL of at least 0.1%; OR\n      * Biopsy confirmed evidence of relapsed T-LLy after second CR; OR\n      * Any detectable disease post-allogeneic transplant with biopsy confirmed evidence of T-LLy\n   2. Refractory disease, defined as:\n\n      * Primary refractory T-ALL or T-LLy, defined as failure to achieve CR after induction chemotherapy, per investigator assessment and based on biopsy-or MRD-confirmed evidence of residual T-ALL or T-LLy; OR\n      * Relapsed, refractory disease, defined as \\> 0.1 % MRD or morphologic evidence of disease or evidence of residual T-LLy after 1 course of re-induction chemotherapy for patients who have relapsed after previously achieving a CR NOTE: Patients with mixed phenotype acute leukemia with T cell dominant phenotype may be enrolled if the aforementioned criteria are met.\n4. Documentation of CD7 expression on leukemic or T-LLy blasts (defined as at least 90% of blasts positive for CD7 by flow cytometry or immunohistochemistry).\n5. Patients with prior or current history of CNS3 disease will be eligible if CNS disease is responsive to therapy\n6. Eligible for myeloablative conditioning for and allogeneic HSCT based on the investigator's assessment with an available donor identified by a FACT accredited transplant center.\n7. Lansky Performance Status (ages \\\u003C 16 years at time of consent) or Karnofsky Performance Status (KPS) (ages ≥ 16 years at time of consent) score of ≥ 50.\n8. Patients of childbearing potential must have a negative urine or serum pregnancy test at screening.\n9. Adequate organ function defined as:\n\n   1. Adequate Serum creatinine based on age\u002Fgender\n   2. ALT ≤ 5x ULN in the absence of ALL infiltration of the liver\n   3. Bilirubin ≤ 3 × ULN for age Note: ALT and\u002For bilirubin results that exceed this range are acceptable if, in the opinion of the physician-investigator (or as confirmed by liver biopsy), the abnormalities are directly related to ALL infiltration of the liver.\n   4. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and \\\u003CGrade 3 hypoxia; DLCO ≥40% (corrected for anemia if necessary) if PFTs are clinically appropriate as determined by the investigator.\n   5. Cardiac echocardiography (ECHO) with left ventricular shortening fraction (LVSF) ≥ 30% or left ventricular ejection fraction (LVEF) ≥ 50%. In cases where quantitative assessment of LVSF\u002FLVEF is not possible, a statement by the cardiologist that the ECHO shows qualitatively normal ventricular function will suffice\n10. Patients who are sexually active and of reproductive potential must agree to use an acceptable form of highly effective contraception from consent to 12 months after BEAM 201 infusion.\n\n4.2 Exclusion Criteria\n\nPatients who meet any of the following criteria will be disqualified from entering the study:\n\n1. Active hepatitis B or active hepatitis C\n2. Active HTLV infection\n3. HIV infection\n4. Uncontrolled, active bacterial, viral, or fungal infection.\n5. CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.\n6. Clinically active CNS dysfunction or known history of irreversible central neurological toxicity related to prior antileukemic therapy.\n7. Receipt of prior CD7 targeted therapy.\n8. Radiation therapy within 2 weeks prior to completion of screening, other than prophylaxis for CNS disease.\n9. Acute GVHD that is grade ≥ 2 and requiring systemic immunosuppression (corticosteroids), or chronic GVHD that is mild, moderate, or severe and requiring systemic immunosuppression (corticosteroids). Grade 1 acute GVHD not requiring immunosuppression is allowable.\n10. Undergone HSCT within 90 days prior to completion of screening (or donor leukocyte infusion, if received within 30 days prior to completion of screening).\n11. Any other condition that would make the patient ineligible for HSCT as determined by the investigator.\n12. Known primary immunodeficiency or BM failure syndrome.\n13. Atrial fibrillation\u002Fflutter (not including isolated episodes that responded to medical management)\n14. Clinically significant pericardial effusion\n15. Myocardial infarction within the last 12 months\n16. QT interval corrected for heart rate \\> 480 msec\n17. Cardiac dysfunction NYHA (New York Heart Association) III or IV\n18. Patients with an autoimmune disorder requiring systemic immunosuppressive therapy that cannot be safely withheld for 3 months.\n\n    Concurrent use of systemic corticosteroids for diagnoses unrelated to T-ALL\u002FT-LLy is prohibited, with exception of physiologic corticosteroid replacement therapy treatment for adrenal insufficiency.\n19. Pregnant or breastfeeding","ALL","0 Years","29 Years",{"count":21,"type":22},33,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This will be a Phase 1, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with R\u002FR T-ALL or T-LLy. BEAM-201 is an allogeneic anti-CD7 CART therapy.",[28],"T-Cell Acute Lymphoblastic Leukemia\u002FLymphoma",[30,31,32],"CART","T-cell leukemia","T-cell lymphoma","RECRUITING","2025-12-24",{"date":36,"type":37},"2025-12-26","ACTUAL",{"date":39,"type":37},"2025-04-29",{"date":41,"type":22},"2031-05-30",{"name":43,"class":44},"Stephan Grupp MD PhD","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100487385","clinical-study-of-senl-t7-car-t-cells-in-the-treatment-of-relapsed-and-refractory-cd7-acute-t-allt-lbl-100487385","NCT05626400","Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL\u002FT-LBL","Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T Lymphoblastic Leukemia and T Lymphoblastic Lymphoma","Inclusion Criteria:\n\n1. Diagnosis of relapsed\u002Frefractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred；\n2. CD7 expression in tumor cells was detected by flow cytometry；\n3. Life expectancy greater than 12 weeks；\n4. KPS or Lansky score≥60;\n5. HGB≥70g\u002FL (can be transfused);\n6. 2-70 years old;\n7. Oxygen saturation of blood#90%#;\n8. HGB≥70g\u002FL（blood transfusion allowed）;\n9. Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;\n10. Informed consent explained to, understood by and signed by patient\u002F guardian.\n\nExclusion Criteria:\n\n1. Any of the following cardiac criteria: Atrial fibrillation\u002Fflutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)\\\u003C30% or LVEF(left ventricular ejection fraction)\\\u003C50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);\n2. Has an active GvHD;\n3. Has a history of severe pulmonary function damaging;\n4. With other tumors which is\u002Fare in advanced malignant and has\u002Fhave systemic metastasis;\n5. Severe or persistent infection that cannot be effectively controlled;\n6. Merging severe autoimmune diseases or immunodeficiency disease;\n7. Patients with active hepatitis B or hepatitis C(\\[HBVDNA+\\]or \\[HCVRNA+\\]);\n8. Patients with HIV infection or syphilis infection;\n9. Has a history of serious allergies on Biological products (including antibiotics);\n10. Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6;\n11. Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, and cerebellar disease, etc.;\n12. Have received transplant treatment for less than 6 months in prior to enrollment;\n13. Being pregnant and lactating or having pregnancy within 12 months;\n14. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.","2 Years","70 Years",{"count":56,"type":22},100,[58],"NA","This is an open, prospective, dose-escalation clinical study to evaluate the safety and efficacy of Senl-T7 in patients with relapsed or refractory CD7+ acute T lymphoblastic leukemia or T lymphoblastic lymphoma.Meanwhile, PK\u002FPD indexes of Senl-T7 were collected.",[61],"T-cell Acute Lymphoblastic Leukemia\u002FLymphoma",[63,64,65,66],"T-ALL","T-LBL","CD7","CAR-T","2022-11-22",{"date":69,"type":37},"2022-11-25",{"date":71,"type":37},"2022-08-29",{"date":73,"type":22},"2027-12-30",{"name":75,"class":76},"Hebei Senlang Biotechnology Inc., Ltd.","INDUSTRY"]