[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-cell-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-cell-malignancies":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,72,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100628760","phase-1-a-study-of-ela026-in-participants-with-relapsedrefractory-rr-tnk-cell-malignancies-tcms-100628760",false,"NCT07465835","A Study of ELA026 in Participants With Relapsed\u002FRefractory (R\u002FR) T\u002FNK Cell Malignancies (TCMs)","Inclusion Criteria:\n\n* Age ≥18 years Participants with a confirmed histologic diagnosis of a TCM who are R\u002FR following any line of prior therapy (participants with CTCLs should have received at least 2 prior lines of systemic therapy for R\u002FR CTCL) and eligible for investigational therapies\n* Presence of measurable disease by clinical examination, radiologic imaging (computed tomography, magnetic resonance imaging, or whole body FDG-PET scans), and\u002For in bone marrow aspirate\u002Fbiopsy\n* Eastern Cooperative Oncology Group performance score of ≤2\n* Anticipated life expectancy \\>6 months per investigator judgment\n\nExclusion Criteria:\n\n* Participants who are eligible for standard of care or approved therapeutic options for R\u002FR TCMs with established clinical benefit\n* Organ dysfunction as defined in the protocol\n* Participants with hemophagocytic lymphohistiocytosis (HLH) based on HLH2004 diagnostic criteria\n* Participants receiving or planning to start immunotherapy or immune effector cell therapy (such as chimeric antigen receptor \\[CAR\\] T-cell therapy, T-cell engagers, or programmed cell death protein 1 \\[PD1\\]\u002Fprogrammed cell death ligand 1 \\[PD-L1\\] inhibitors)\n* Allogeneic hemopoietic stem cell transplant within 100 days prior to the first dose of ELA026 and currently receiving systemic immunosuppressive therapy\n* Women of childbearing potential who are planning to become pregnant or are breastfeeding during the conduct of the study, including 60 days after last dose of study drug\n* Male participants whose partners are women of childbearing potential and who are planning to become pregnant during the conduct of this trial by the male partner, including within 60 days after the last dose of study drug","ALL","18 Years",{"count":18,"type":19},84,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This is a Phase 1, two-part, multicenter study to evaluate ELA026 in participants ≥18 years old with relapsed\u002Frefractory TCM following any line of prior therapy who are eligible for investigational treatments.",[25],"T Cell Malignancies",[27,28,29,30],"T cell Malignancies","Lymphoma","SIRP protein","ELA026","RECRUITING","2026-05-17",{"date":34,"type":35},"2026-05-20","ACTUAL",{"date":37,"type":35},"2026-02-17",{"date":39,"type":19},"2028-12",{"name":41,"class":42},"Electra Therapeutics Inc.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":5},"100540439","phase-1-cd5-chimeric-antigen-receptor-car-t-cells-in-subjects-with-relapsed-or-refractory-t-cell-malignancies-100540439","NCT06316856","CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-cell Malignancies","CD5 Chimeric Antigen Receptors (CAR) T Cells in Subjects With Relapsed or Refractory T-Cell Malignancies: a Multi-center, Open-label, Non-randomized, Phase 1\u002F2 Clinical Trial","Inclusion Criteria:\n\nOnly patients who meet all the following criteria can be included:\n\n1. Candidates with relapse or refractory CD5+ T-cell malignancies, who have progressed after treatment with all standard therapies or been intolerant of standard care, have limited prognosis with currently available therapies and have no available curative treatment options (such as stem-cell transplantation (SCT) or chemotherapy);\n2. For subjects who received autologous CD5 CAR T cells, the tumor burden in peripheral blood is less than 20%, and suspending anti-neoplastic treatment for more than 2 weeks;\n3. Aged 1-70 years;\n4. No severe allergy;\n5. Eastern Cooperative Oncology Group (ECOG) performance status 1 score 0 to 2;\n6. Patients are expected to live for at least 60 days;\n7. CD5+ on blasts in bone marrow (BM) or cerebrospinal fluid (CSF) and tumor tissues by flow cytometry and immunohistochemistry, respectively. (Positive rate \\>80% by flow cytometry with less than one log difference in mean fluorescence intensity from normal T cells, or positive rate \\>30% positive by immunohistochemistry);\n8. Provide a signed informed consent before any screening procedure. Subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. Children candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form and their legal guardian or patient advocate has also need to sign the treatment consent form and voluntary consent form, respectively. Children candidates of 1-7 can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form;\n9. Have available allogeneic hematopoietic stem cell transplantation donor for the subject who received newly matched donor-derived CD5 CAR T cells, and is willing to perform SCT when CR is achieved.\n\nExclusion Criteria:\n\nPatients with at least one of the following conditions are excluded:\n\n1. Impaired consciousness or intracranial hypertension;\n2. Symptomatic congestive heart failure or severe cardiac arrhythmia;\n3. Manifestations of severe respiratory system failure;\n4. Co-existence with other malignancies;\n5. Disseminated intravascular coagulation;\n6. Serum creatinine and\u002For blood urea nitrogen (BUN) ≥ 1.5-fold upper limit;\n7. Sepsis or other uncontrollable infections;\n8. Uncontrollable diabetes;\n9. Serious mental illness;\n10. Apparent and active intracranial lesions on cranial magnetic resonance imaging (MRI);\n11. Underwent organ transplantation, excepting SCT;\n12. Pregnant females;\n13. Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS) or syphilis;\n14. Post-CAR SCT is not feasible in patients who plan to receive newly matched donor-derived CD5 CAR T cells;\n15. Inability to collect peripheral blood mononuclear cells (PBMC) or no frozen PBMC available for CAR T cell manufacturing.","1 Year","70 Years",{"count":53,"type":19},54,[22,55],"PHASE2","This is a multi-center, open-label, non-randomized, phase 1\u002F2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10\\^6 (±20%) to dose level 2: 2×10\\^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10\\^5 (±20%) \u002Fkg. The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1, the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in phase 2. A total number of 54 subjects will be enrolled.",[58,59,60,61],"T-Cell Acute Lymphocytic Leukemia","Acute Lymphoblastic Leukemia, in Relapse","Refractory Acute Lymphoblastic Leukemia","T-cell Malignancies","2026-03-06",{"date":64,"type":35},"2026-03-10",{"date":66,"type":35},"2024-06-18",{"date":68,"type":19},"2026-12-30",{"name":70,"class":71},"Beijing GoBroad Hospital","OTHER",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":51,"enrollmentInfo":79,"targetDuration":4,"studyType":20,"phases":80,"briefSummary":56,"conditions":81,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":5},"100598348","phase-1-a-multicenter-open-label-non-randomized-single-arm-clinical-study-of-nanobody-cd5-car-t-cell-therapy-for-refractoryrelapsed-t-lymphocyte-malignancies-100598348","NCT07070323","A Multicenter, Open-Label, Non-Randomized, Single-Arm Clinical Study of Nanobody CD5-CAR T Cell Therapy for Refractory\u002FRelapsed T Lymphocyte Malignancies","nanobody CD5","Inclusion Criteria:\n\nOnly patients who meet all the following criteria can be included:\n\n1\\. Candidates with relapse or refractory CD5+ T-cell malignancies, who have progressed after treatment with all standard therapies or been intolerant of standard care, have limited prognosis with currently available therapies and have no available curative treatment options (such as stem-cell transplantation (SCT) or chemotherapy); 2. For subjects who received autologous CD5 CAR T cells, the tumor burden in peripheral blood is less than 20%, and suspending anti-neoplastic treatment for more than 2 weeks; 3. Aged 1-70 years; 4. No severe allergy; 5. Eastern Cooperative Oncology Group (ECOG) performance status 1 score 0 to 2; 6. Patients are expected to live for at least 60 days; 7. CD5+ on blasts in bone marrow (BM) or cerebrospinal fluid (CSF) and tumor tissues by flow cytometry and immunohistochemistry, respectively. (Positive rate \\>80% by flow cytometry with less than one log difference in mean fluorescence intensity from normal T cells, or positive rate \\>30% positive by immunohistochemistry); 8. Provide a signed informed consent before any screening procedure. Subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. Children candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form and their legal guardian or patient advocate has also need to sign the treatment consent form and voluntary consent form, respectively. Children candidates of 1-7 can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form; 9. Have available allogeneic hematopoietic stem cell transplantation donor for the subject who received newly matched donor-derived CD5 CAR T cells, and is willing to perform SCT when CR is achieved.\n\n\\-\n\nExclusion Criteria:\n\nPatients with at least one of the following conditions are excluded:\n\n1\\. Impaired consciousness or intracranial hypertension; 2. Symptomatic congestive heart failure or severe cardiac arrhythmia; 3. Manifestations of severe respiratory system failure; 4. Co-existence with other malignancies; 5. Disseminated intravascular coagulation; 6. Serum creatinine and\u002For blood urea nitrogen (BUN) ≥ 1.5-fold upper limit; 7. Sepsis or other uncontrollable infections; 8. Uncontrollable diabetes; 9. Serious mental illness; 10. Apparent and active intracranial lesions on cranial magnetic resonance imaging (MRI); 11. Underwent organ transplantation, excepting SCT; 12. Pregnant females; 13. Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS) or syphilis; 14. Post-CAR SCT is not feasible in patients who plan to receive newly matched donor-derived CD5 CAR T cells; 15. Inability to collect peripheral blood mononuclear cells (PBMC) or no frozen PBMC available for CAR T cell manufacturing.\n\n\\-",{"count":53,"type":19},[22,55],[58,59,60,61],"2025-11-21",{"date":84,"type":35},"2025-11-26",{"date":86,"type":35},"2025-07-09",{"date":88,"type":19},"2026-12-31",{"name":70,"class":71},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":51,"enrollmentInfo":97,"targetDuration":4,"studyType":20,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":5},"100540406","phase-1-autologous-and-donor-derived-cd7-car-t-therapy-in-refractory-or-relapsed-t-cell-malignancies-100540406","NCT06316427","Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Malignancies","Autologous and Donor-derived CD7 CAR T-cell Therapy in Refractory or Relapsed T-cell Malignancies: a Multi-center, Open-label, Phase Ⅰ\u002FⅡ Clinical Trial","Inclusion Criteria:\n\nOnly patients who meet all the following criteria can be included in the group:\n\n1. CD7-positive refractory or relapsed T-cell malignancies with progression or intolerance after all standard treatments, limited prognosis from currently available treatments and no available treatment options (e.g. HSCT or chemotherapy).\n2. Tumor cells in bone marrow or cerebrospinal fluid are positive for CD7 antigen by flow cytometry or tumour tissue is positive for CD7 by immunohistochemistry (CD7 antigen positivity by flow cytometry: \\>80% of tumour cells expressing CD7 with a mean fluorescence intensity \\[MFI\\] of CD7 similar to that of normal T cells are considered to have fully positive expression; \\>80% of tumor cells expressing CD7 but with an MFI of CD7 at least 1 log lower than that of normal T cells are considered to have low expression \\[dim\\]; tumor cells with a CD7 expression rate between 20-80% are considered to have partial expression; CD7 antigen positivity by pathological immunohistochemistry: \\>30%);\n3. Male or female, age 1-70 years;\n4. No severe allergic constitution;\n5. Eastern Cooperative Oncology Group (ECOG) performance status score (Oken et al., 1982) of 0-2;\n6. Life expectancy of at least 60 days as determined by the investigator;\n7. Provide a signed informed consent form prior to any screening procedures; subjects volunteering to participate in the study should be capable of understanding and signing the informed consent form and be willing to follow the study visit schedule and associated study procedures as specified in the protocol. Subjects aged 19-70 years old need to be sufficiently aware and capable of signing the informed consent form; subjects aged 1-7 years can be recruited after legal guardians or patient advocates sign the informed consent form; subjects aged 8-18 years need to be sufficiently aware and able to sign the informed consent form, and their legal guardians or patient advocates also need to sign the informed consent form.\n\nExclusion Criteria:\n\nPatients with at least one of the following conditions are excluded:\n\n1. Intracranial hypertension or unconscious;\n2. Acute heart failure or severe arrhythmia;\n3. Acute respiratory failure;\n4. Other types of malignant tumors;\n5. Diffuse intravascular coagulation;\n6. Serum creatinine and\u002For blood urea nitrogen over 1.5 times the normal value;\n7. Sepsis or other uncontrolled infection;\n8. Uncontrolled diabetes mellitus;\n9. Severe psychological disorder;\n10. Obvious cranial lesions by cranial MRI;\n11. Allergic constitution;\n12. Organ recipients;\n13. Pregnant or breastfeeding;\n14. Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).",{"count":98,"type":19},80,[22,55],"This is a multi-center, open-label, non-randomized, phase I\u002FII trial. Patients with refractory or relapsed T-cell malignancies will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r\u002Fr T-ALL\u002FT-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r\u002Fr T-ALL\u002FT-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia\u002Flymphoma (r\u002Fr T-ALL\u002FT-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled.",[102,59,60,61],"T-cell Acute Lymphoblastic Leukemia",{"date":84,"type":35},{"date":105,"type":35},"2024-03-22",{"date":107,"type":19},"2028-03-30",{"name":70,"class":71}]