[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-all\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-all":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,70,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100565954","phase-2-isatuximab-in-adult-patients-with-cytologic-or-molecular-relapsedrefractory-cd38-positive-t-cell-acute-lymphoblastic-leukemia-100565954",false,"NCT06648889","Isatuximab in Adult Patients With Cytologic or Molecular Relapsed\u002FRefractory CD38 Positive T-cell Acute Lymphoblastic Leukemia","A Multicenter, Single-arm Phase II Study to Assess the Safety, Tolerability, and Efficacy of Isatuximab in Adult Patients With Cytologic or Molecular Relapsed\u002FRefractory CD38 Positive T-cell Acute Lymphoblastic Leukemia (GMALL-Isatuximab)","Inclusion Criteria:\n\n\\- Patients with CD38 positive T-ALL fitting either to the definitions for cohort 1 or cohort 2:\n\nCohort 1: In relapse or with primary refractory disease defined as ≥5% blasts in bone marrow after at least three chemotherapy cycles (induction I-II, consolidation I) with the following additional specifications:\n\n* early relapse within 12 months from first achievement of CR or\n* late relapse later than 12 months from first achievement of CR or\n* primary refractory disease without any CR or\n* any relapse after stem cell transplantation or\n* any refractory relapse, defined as no response to at least one salvage therapy or\n* any second or later relapse and\n* Availability of patient material with blast cells (bone marrow or peripheral blood) for central MRD assessment or availability of respective predefined marker.\n\nCohort 2: In complete hematological remission (defined as less than 5% blasts in bone marrow and no evidence of extramedullary disease) after at least three chemotherapy cycles (induction I-II, consolidation I)\n\n* Detection of quantifiable MRD at a level of ≥10-4, either as molecular failure without prior achievement of molecular remission or molecular relapse after prior achievement of molecular remission\n* MRD assay at the central reference lab with at least one marker a minimum sensitivity of 10-4\n* MRD detection for study inclusion after an interval of at least 2 weeks from last systemic chemotherapy including antibody therapy\n* (in patients without clonal molecular MRD marker, MRD testing can be based on flow-cytometry established in reference laboratory)\n\nECOG status:\n\n* Cohort 1: 0-2\n* Cohort 2: 0-1\n\nAge ≥ 18 years Evidence of a personally signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures\n\nRegeneration from last chemotherapy defined as follows:\n\nCohort 1:\n\n* Platelets ≥10.000\u002FuL (platelet transfusion allowed)\n* Hemoglobin ≥ 7.5 g\u002Fdl (red blood cell transfusion allowed)\n\nCohort 2:\n\n* Neutrophils ≥1.000\u002FuL\n* Platelets ≥50.000\u002FuL\n* Hemoglobin ≥9 g\u002Fdl\n\nAdequate liver function defined as follows:\n\n* Bilirubin ≤ 1.5 ULN (unless Gilbert Meulengracht disease or classified as result of liver infiltration by investigator)\n* AST and ALT ≤ 2.5 x ULN (unless classified as result of liver infiltration by investigator)\n\nAdequate renal function defined as follows:\n\n* Serum creatinine ≤ 2 x ULN\n* Any serum creatinine level associated with a calculated creatinine clearance ≤ 40 mL\u002Fmin\n* Negative pregnancy test in women of childbearing potential (WOCBP)\n* WOCBP must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously.\n* Men who are sexually active with a WOCBP must agree to use a barrier method of contraception\n* Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)\n\nExclusion Criteria:\n\n* Extramedullary involvement except for non-bulky (\\\u003C7.5 cm) lymph node involvement, splenomegaly, or hepatomegaly\n* Patients who have received prior antileukemic immunotherapy within 2 weeks prior to start of Isatuximab treatment\n* Patients who have received treatment for leukemia with chemotherapy as follows:\n\nCohort 1:\n\n* Patients who have received treatment for leukemia with chemotherapy within 2 weeks prior to start of Isatuximab treatment (exception: pre-phase therapy with 5-7 days of Dexamethasone, 3 days of Cyclophosphamide; intrathecal prophylaxis)\n* Patients who are candidates for a treatment with Nelarabine\n\nCohort 2:\n\n* Any chemotherapy or antibody therapy after the MRD assay leading to study inclusion (exception: intrathecal prophylaxis)\n* Patients must have recovered from acute non-hematologic toxicity from previous therapies to ≤ grade I unless signs or symptoms are correlated to leukemia involvement\n* Prior SCT ≤ 3 months from start of study treatment\n* Acute GvHD ≥ grade II or active chronic GvHD requiring systemic treatment\n* Any systemic GvHD prophylaxis or treatment within 2 weeks from start of study treatment\n* Known HIV positivity, known hepatitis B surface antigen positivity or known history of hepatitis C\n* Unstable or severe uncontrolled medical condition e.g. unstable cardiac function or unstable pulmonary condition\n* Treatment with an investigational agent within 4 weeks from start of study treatment (safety follow-up period of respective study)\n* Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been treated with radiation or surgery; patients with previous malignancies are eligible if they have been disease free for ≥ 2 years and do not require any antitumor therapy.\n* Evidence of uncontrolled current serious active infection or recent history (within 4 months) of deep tissue infections such as fasciitis or osteomyelitis\n* Known allergies, hypersensitivity, or intolerance to boron or Mannitol, corticosteroids, mAb (including Isatuximab) or human proteins, or their excipients (refer to respective Summary of Product Characteristics), or known sensitivity to mammalian-derived products.\n* Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator\n* Pregnant or breastfeeding females\n* Vaccination with live attenuated vaccines within 4 weeks of first study agent administration.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient inappropriate for entry into this study","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The planned trial offers treatment cohorts for patients with full cytologic relapse (R\u002FR ALL - Cohort 1), as well as for patients with molecular failure\u002Frelapse (MRD+ ALL - Cohort 2). Basically, the study aims to develop data for optimization of first-line therapy of T-ALL, either by modification of standard induction with Isatuximab or by establishing a post-induction therapy for eradication of MRD and thereby evaluates in parallel two different strategies.",[26],"T-ALL",[28],"R\u002FR or MRD CD38-positive T-ALL","RECRUITING","2026-06-18",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":33},"2024-10-22",{"date":37,"type":20},"2028-08",{"name":39,"class":40},"Goethe University","OTHER",15,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100386972","phase-1-cd123-directed-t-cell-therapy-for-acute-myelogenous-leukemia-catchaml-100386972","NCT04318678","CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)","Inclusion Criteria for Procurement and T-cell Production:\n\n* Age ≤21 years old\n* Relapsed\u002Frefractory CD123+ disease defined as follows:\n\nAML\u002FMDS\n\n* Relapsed disease: Patients developing recurrent disease after a first complete remission (CR)\n* Refractory disease: Patients not achieving a CR after 2 cycles of induction chemotherapy\n\nB-cell ALL\n\n* Relapsed disease that is CD123 positive and CD19 negative\u002Fdim or patients otherwise ineligible for CD19 directed therapies including\n\n  * Patients in 2nd or greater relapse\n  * Patients with relapse after allogeneic HSCT\n* Refractory disease that is CD123 positive and CD19 negative\u002Fdim or patients otherwise ineligible for CD19 directed therapies\n\nT-cell All • Relapsed refractory disease that is CD123 positive\n\nBPDCN\n\n• Relapsed\u002Frefractory disease that has failed front-line therapy\n\n* Estimated life expectancy of \\>12 weeks\n* Karnofsky or Lansky (age-dependent) performance score ≥50\n* Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis\n* Patient must have an identified, suitable HCT donor\n* For females of child-bearing age:\n* Not lactating with intent to breastfeed\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* History of HIV infection\n* Severe intercurrent uncontrolled bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)\n* History of hypersensitivity reactions to murine protein-containing products\n* Patients with acute promyelocytic leukemia (APL, t (15;17))\n* Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine\u002Fcyclophosphamide.\n\nInclusion Criteria for Treatment:\n\n* Age≤21 years old\n* Detectable disease that is CD123+ (at least MRD+ disease)\n* Estimated life expectancy of \\>8 weeks\n* Karnofsky or Lansky (age-dependent) performance score≥50\n* Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to planned infusion\n* Patient must have an identified, suitable HCT donor\n* Adequate cardiac function defined as left ventricular ejection fraction \\>40%, OR shortening fraction ≥25%\n* EKG without evidence of clinically significant arrhythmia\n* Adequate renal function defined as creatinine clearance or radioisotope GFR ≥50 ml\u002Fmin\u002F1.73m2 (GFR ≥40 ml\u002Fmin\u002F1.73m2 if \\\u003C 2 years of age)\n* Adequate pulmonary function defined as forced vital capacity (FVC)≥50% of predicted value; or pulse oximetry≥92% on room air if patient is unable to perform pulmonary function testing\n* Total Bilirubin≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome\n* Alanine aminotransferase (ALT) OR aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age\n* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy\n* For females of child-bearing age\n\n  * Not lactating with intent to breastfeed\n  * Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* If sexually active, agreement to use birth control until 3 months after T- cell infusion. Male partners should use a condom.\n* Available autologous transduced T-cell product that has met GMP release criteria\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* History of HIV infection\n* Severe intercurrent uncontrolled bacterial, viral or fungal infection\n* History of hypersensitivity reactions to murine protein-containing products\n* History of severe hypersensitivity reactions to cornstarch or hydroxyethyl starch.\n* Receiving systemic steroids therapy exceeding the equivalent of 0.5 mg\u002Fkg\u002Fday of methylprednisolone, in the 7 days prior to CD123-CAR T- cell infusion\n* Receiving systemic therapy in the 14 days prior to CD123-CAR T-cell infusion, which will interfere with the activity of the CD123-CAR T cells in vivo (in the opinion of the study PI(s))\n* Receiving rituximab therapy in the 30 days prior to CD123-CAR T cell infusion. (This exclusion criterion is intended to prevent premature exposure of CD123-CAR T cells to rituximab, which would activate the safety switch and promote CAR T-cell apoptosis).\n* Receiving intrathecal chemotherapy in the 7 days prior to CD123-CAR T cell infusion.\n* Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine\u002Fcyclophosphamide.\n* Active CNS disease","21 Years",{"count":50,"type":20},108,[52],"PHASE1","The CD123-CAR T-cell therapy is a new treatment that is being investigated for treatment of AML\u002Fmyelodysplastic syndrome (MDS), T- or B- acute lymphoblastic leukemia (ALL) or blastic plasmacytoid dendritic cell neoplasia (BPDCN). The purpose of this study is to find the maximum (highest) dose of CD123-CAR T cells that is safe to give to these patients. This would include studying the side effects of the chemotherapy, as well as the CD123-CAR T-cell product on the recipient's body, disease and overall survival.\n\nPrimary Objective:\n\n* To determine the safety of one intravenous infusion of escalating doses of autologous, CD123-CAR T cells in patients (≤21 years) with recurrent\u002Frefractory CD123+ disease (AML\u002FMDS, B-ALL, T-ALL or BPDCN) after lymphodepleting chemotherapy.\n* To determine the safety of an intravenous infusion of escalating doses of donor derived, CD123-CAR T cells in patients (≤21 years) with recurrent\u002Frefractory CD123+ disease (AML\u002FMDS, B-ALL, T-ALL, BPDCN or MPAL) after lymphodepleting chemotherapy.\n\nSecondary Objectives\n\n\\- To evaluate the antileukemia activity of CD123-CAR T cells.\n\nExploratory Objectives\n\n* To assess the immunophenotype, clonal structure and endogenous repertoire of CD123-CAR T cells and unmodified T cells\n* To characterize the cytokine profile in the peripheral blood and CSF after treatment with CD123-CAR T cells\n* To characterize tumor cells post CD123-CAR T-cell therapy\n* To compare in vivo properties of donor-derived versus autologous CD123- CAR T cells",[55,56,26,57],"AML\u002FMDS","B-ALL","BPDCN",[59],"CD123+","2026-05-18",{"date":62,"type":33},"2026-05-19",{"date":64,"type":33},"2020-07-29",{"date":66,"type":20},"2030-07-29",{"name":68,"class":40},"St. Jude Children's Research Hospital",2,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":17,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100581368","early-phase-1-the-safety-and-efficacy-of-vgo-cs01p-in-patients-with-cd7-positive-relapsedrefractory-acute-t-lymphoblastic-leukemia-100581368","NCT06849401","The Safety and Efficacy of VGO-Cs01p in Patients With CD7-positive Relapsed\u002FRefractory Acute T-lymphoblastic Leukemia","A Single-arm, Open Label Clinical Study to Evaluate the Safety and Efficacy of VGO-Cs01p in Patients With CD7-positive Relapsed\u002FRefractory Acute T-lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age ≥2 and ≤18 years old, male or female;\n2. Subjects who have relapse or refractory T-cell lymphoblastic leukemia (T-ALL) according to the standards of the NCCN Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2024.V6);\n3. Meets the criteria for recurrent or refractory T-ALL, including: a) Recurrent: Reappearance of blasts in peripheral blood or bone marrow (\\>25%) after complete remission or occurrence of extramedullary disease, and ineffectiveness of other treatments； b) Primary Refractory: Appearance of blasts in bone marrow ≥5% after 2 months standard induction chemotherapy, and no other treatment can be used as judged by the investigator;\n4. After one cycle of other treatments (such as Olverembatinib combined with APG-125), the blasts remain≥5%;\n5. Cell immunophenotyping confirmation of CD7 positive blasts \\>80%;\n6. Estimated survival period \\>12 weeks;\n7. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1 or KPS \\> 60;\n8. Left ventricular ejection fraction ≥50%;\n9. Pulmonary function ≤ Grade 1 dyspnea (CTCAE v5.0), normal oxygen saturation without oxygen supplementation;\n10. TBil ≤ 3×ULN, AST and ALT ≤ 5×ULN, creatinine ≤ 1.6 mg\u002Fdl within 1 week prior to enrollment;\n11. Negative serum pregnancy test for fertile women; fertile non-abstinent female patients must agree to use an effective contraceptive method from screening to 1 year after cell infusion. Fertile male patients' partners must agree to use effective contraception from screening to 1 year after cell infusion, and should not donate semen or sperm throughout the study;\n12. The subject or their legal guardian voluntarily participates in the study, understands the information, purpose, and risks described in the informed consent form, and can provide a signed and dated informed consent form;\n13. The subject and\u002For their parents or their legal guardian should voluntary and able to comply with all requirements of the trial.\n\nExclusion Criteria:\n\n1. Extramedullary involvement of the central nervous system or testicular at screening.\n2. Patients with a history of severe CNS diseases, such as uncontrolled seizures, stroke, severe brain damage resulting in speech impairment, psychiatric disorders, etc;\n3. NYHA functional class III or IV heart failure;\n4. Presence of disseminated intravascular coagulation;\n5. Presence of severe autoimmune diseases or immune deficiency diseases;\n6. Active GVHD requiring systemic treatment;\n7. Presence of other severe diseases, presence of gastrointestinal ulcers or active gastrointestinal bleeding, currently undergoing anticoagulant or antiplatelet therapy, or judged by the investigator to pose unacceptable surgical or anesthesia risks;\n8. Currently receiving systemic steroids or other immunosuppressive therapy prior to screening, and still need long-term use after enrollment as judged by the investigator (excluding inhaled or local use);\n9. History or concurrent active malignant tumors within 3 years prior to enrollment;\n10. Active HBV or HCV infection (HBV-DNA positive or HCV-RNA positive), HIV positive, or positive syphilis test;\n11. Other severe or persistent active infections;\n12. Adverse events related to previous systemic immunotherapy (including other investigational drugs or medical device interventions) prior to enrollment have not reduced to grade 1 severity or returned to baseline;\n13. Platelet count remains low after intervention treatment (meeting clinical transfusion criteria) prior to enrollment；\n14. Discontinuation of immunosuppressive agents for less than 2 weeks;\n15. Participation in CAR-T cell therapy or gene therapy at any time prior to screening;\n16. History of allergy to any component of the study product;\n17. Vaccination or any surgery within the 4 weeks prior to screening;\n18. Other situations as judged by the investigator may increase the subject's risk or interfere with study;\n19. Pregnant or breastfeeding women;\n20. Individuals assessed by the investigator to have potential hidden risks of disputes.","2 Years",{"count":79,"type":20},9,[81],"EARLY_PHASE1","To learn if the VGO-Cs01p can help to control CD7-positive relapsed\u002Frefractory acute T-lymphoblastic leukemia (R\u002FR T-ALL) in children.",[26],"NOT_YET_RECRUITING","2025-05-12",{"date":87,"type":33},"2025-05-15",{"date":89,"type":20},"2025-07",{"date":91,"type":20},"2026-10",{"name":93,"class":40},"Shanghai Jiao Tong University School of Medicine",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":117},"100526563","phase-1-cd7-car-t-in-adults-with-relapsed-or-refractory-t-lblall-clinical-study-100526563","NCT06136364","CD7 CAR-T in Adults With Relapsed or Refractory T-LBL\u002FALL Clinical Study","Open-label, Dose-escalation Phase 1 Clinical Study of SENL101 Autologous T Cell Injection in the Treatment of Adult Patients With Relapsed or Refractory T-LBL\u002FALL","Inclusion Criteria:\n\nAccording to the WHO hematopoietic and lymphoid tissue tumors classification, Subjects with refractory\u002Frelapsing T-LBL\u002FALL has been adequately treated and there is a lack of effective treatment, met one of the following criteria:\n\n1. relapse: Primordial cells (\\>5%)in peripheral blood or bone marrow appeared again after complete remission with standard treatment or Extramedullary disease appears，include：\n\n   1. Early recurrence within 12 months，\n   2. Late recurrence at 12 months or above and with no remission after a course of standard induction chemotherapy，\n   3. Recurrence after autologous or allogeneic hematopoietic stem cell transplantation ;\n2. Refractory: patients who have received at least two courses standard induction regimen and failed to achieve a complete response or complete remission was not achieved after first-line or above salvage treatment;\n3. The tumor cells detected by bone marrow flow cytometry were CD7+ and\u002For extramedullary lesions were diagnosed as CD7+ by pathological immunohistochemistry at the time of enrollment and screening;\n4. If tumor cells were detected in peripheral blood during enrollment and screening, it was required to meet the requirement that the surface immunophenotype of tumor cells was CD4 and CD8 double negative by flow cytometry.\n5. Life expectancy greater than 12 weeks;\n6. ECOG 0-2;\n7. Age 18-75 (upper and lower limits included);\n8. HGB at least 70g\u002FL,PLT 50x109\u002FL, can be transfused;\n9. Liver and kidney functions The cardiopulmonary functions meet the following requirements:\n\n   1. Oxygen saturation under air ≥ 92%;\n   2. LVEF≥50%;\n   3. Total bilirubin \\\u003C3×ULN;\n   4. ALT\u002FAST\\\u003C3×ULN;\n   5. Creatinine \\\u003C1.5×ULN or creatinine clearance rate(Cockroft-Gault)\\>50ml\u002Fmin;\n10. Informed consent explained to, understood by and signed by patient\u002F guardian.\n\nExclusion Criteria:\n\nThose who meet any of the following criteria are not eligible to join the group:\n\n1. New York Heart Association (NYHA) classification ≥ grade III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically prominent heart disease within one year before signing the informed consent form, Or QTc interval \\>480ms at screening (QTc interval calculated by Fridericia formula);\n2. If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell transplantation;\n3. Those with active GvHD or those who require immunosuppressive therapy;\n4. Malignancy other than T-cell acute lymphoblastic leukemia\u002Flymphoma within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, radical surgery ductal carcinoma in situ;\n5. History of non-neoplastic central nervous system disease (Seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy)\n6. Active or uncontrollable infection requiring systemic treatment within 7 days prior to screening (except for mild urogenital infections and upper respiratory tract infections);\n7. History of autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) requiring systemic immunosuppressive\u002Fsystemic disease modulating medication within the past 2 years;\n8. When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) is positive, and the peripheral blood hepatitis B virus (HBV) DNA is higher than the detection limit, it needs to be excluded; if the hepatitis C virus (HCV) antibody is positive, the peripheral blood HCV Those with positive RNA need to be excluded; those with positive human immunodeficiency virus (HIV) antibody; those with positive cytomegalovirus (CMV) DNA test; those with positive test for Treponema pallidum specific antibody (TPPA) need to be excluded;\n9. Participate in other clinical trials within 4 weeks before the informed consent is signed, or the date of the informed consent is signed and the last medication of the drug is still within 5 half-lives of the drug (whichever is longer);\n10. History of severe allergy to biological products;\n11. Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy;\n12. Pregnant or breastfeeding women, and female subjects planning pregnancy within 2 years of cell infusion or male subjects whose partner is planning pregnancy within 2 years of cell infusion;\n13. Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening;\n14. Circumstances that the investigator believes may increase the risk to the subject or interfere with the results of the trial.","75 Years",{"count":79,"type":20},[52],"To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL\u002FALL.",[106,26],"T-lymphoblastic Lymphoma","2023-11-14",{"date":109,"type":33},"2023-11-18",{"date":111,"type":33},"2023-08-15",{"date":113,"type":20},"2038-08-14",{"name":115,"class":116},"Hebei Senlang Biotechnology Inc., Ltd.","INDUSTRY",1]