[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-cell-acute-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-cell-acute-lymphoblastic-leukemia":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,49,85,108,124,146,169,196,222,251,280,307,328,354,382,407,430,459],{"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":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100645083","phase-1-a-multicenter-open-label-non-randomized-single-arm-phase-12-study-of-autologous-nano-cd5-car-t-cells-for-the-treatment-of-relapsedrefractory-t-cell-acute-lymphoblastic-leukemialymphoma-100645083",false,"NCT07678307","A Multicenter, Open-label, Non-randomized, Single-arm Phase 1\u002F2 Study of Autologous Nano CD5-CAR T Cells for the Treatment of Relapsed\u002FRefractory T-cell Acute Lymphoblastic Leukemia\u002FLymphoma","A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase 1\u002F2 Study of Autologous Nano CD5-CAR T Cells for the Treatment of Relapsed\u002FRefractory T-Cell Acute Lymphoblastic Leukemia\u002FLymphoma","Inclusion Criteria:\n\n* Age 3 to 70 years old\n* Diagnosed with CD5-positive relapsed\u002Frefractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)\n* ECOG performance status 0-2\n* Adequate organ function (renal, hepatic, cardiac, pulmonary)\n* Able to understand and sign informed consent\n\nExclusion Criteria:\n\n* Active severe infection or uncontrolled sepsis\n* History of allogeneic stem cell transplantation within 3 months\n* Severe autoimmune disease or immunodeficiency\n* Prior CD5-targeted therapy\n* Pregnant or breastfeeding women\n* Any condition that, in the investigator's opinion, would compromise safety or compliance with the protocol","ALL","3 Years","70 Years",{"count":5,"type":20},"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a clinical research study for people with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoma.\n\nThe study will test a new treatment called \"autologous nano CD5-CAR T cells\". These are your own immune cells that have been changed in a lab to recognize and kill cancer cells.\n\nThis study has two parts: Phase 1 to test the safety and best dose of the treatment, and Phase 2 to see how well it works.\n\nYou may receive the study treatment if you meet all the eligibility criteria. The main things the study will look at are: how safe the treatment is, how many people's cancer goes away or gets better, and how long the effect lasts.\n\nPossible risks include fever, low blood pressure, and infection, which the study team will monitor closely.",[27,28,29],"T-Cell Acute Lymphoblastic Leukemia","T-Lymphoblastic Lymphoma","Relapsed\u002FRefractory Hematologic Malignancies",[31,32,33,34,35,36],"CD5-CAR-T Cell Therapy","Nano CAR-T","Relapsed Refractory T-ALL","Relapsed Refractory T-Lymphoblastic Lymphoma","Phase 1\u002F2 Clinical Trial","Hematologic Malignancies","NOT_YET_RECRUITING","2026-06-25",{"date":40,"type":41},"2026-07-01","ACTUAL",{"date":43,"type":20},"2026-06-30",{"date":45,"type":20},"2027-12-31",{"name":47,"class":48},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100515709","phase-1-universal-4scar7u-targeting-cd7-positive-malignancies-100515709","NCT05995028","Universal 4SCAR7U Targeting CD7-positive Malignancies","Safety and Efficacy of Universal 4SCAR7U T Cell Therapy Targeting CD7-positive Hematological Malignancies","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. Confirmed expression of CD7 and additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry.\n3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \\> 3 months.\n4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg\u002FdL.\n5. Hgb≥80g\u002FL.\n6. No cell separation contraindications.\n7. Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n2. Active bacterial, fungal or viral infection not controlled by adequate treatment.\n3. Known HIV or hepatitis C virus (HCV) infection.\n4. Pregnant or nursing women may not participate.\n5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial.\n6. Previous treatment with any gene therapy products.\n7. Patients, in the opinion of investigators, may not be able to comply with the study.","6 Months","75 Years",{"count":59,"type":20},30,[23],"The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T cells based on 4SCAR7U design against CD7-positive hematological malignancies using CD7 specific universal CAR T cells. The study also aims to learn more about the function of CD7 targeting CAR T cells and their persistence in patients of hematological malignancies.",[63,64,65,66],"T-cell Acute Lymphoblastic Leukemia","T-cell Acute Lymphoblastic Lymphoma","Acute Myeloid Leukemia","NK Cell Lymphoma",[68,69,70,71,72,73],"T-ALL","TCL","AML","NK lymphoma","Universal CAR T","CD7","RECRUITING","2026-06-18",{"date":77,"type":41},"2026-06-23",{"date":79,"type":41},"2023-10-31",{"date":81,"type":20},"2026-12-31",{"name":83,"class":48},"Shenzhen Geno-Immune Medical Institute",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":84},"100460601","phase-1-ngs-mrd-assessment-of-combination-immunotherapies-targeting-t-all-100460601","NCT05277753","NGS-MRD Assessment of Combination Immunotherapies Targeting T-ALL","NGS-MRD Evaluation of Antigen-specific T Cells and DC Vaccine Combination Targeting T-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. High-burden (≥ 30% blast cells) bone marrow sample for NGS TCR clonal identification and CTL\u002FDC vac preparation is required\n3. Expression of CD7, CD5, CD317, CD47, CD99, CD38 or TRBC1\u002F2 is determined in malignant cells by flow cytometry or immuno-histochemical staining.\n4. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \\> 3 months.\n5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5x upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x upper limit of normal, total bilirubin ≤ 2.0 mg\u002FdL.\n6. Hgb ≥ 80g\u002FL.\n7. No cell separation contraindications.\n8. Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n2. Active bacterial, fungal or viral infection not controlled by adequate treatment.\n3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n4. Pregnant or nursing women may not participate.\n5. History of glucocorticoid for systemic therapy within the week prior to entering the test.\n6. Previous treatment with any gene therapy products.\n7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.","65 Years",{"count":94,"type":20},10,[23],"The purpose of this study is to determine the feasibility, safety, and efficacy of a combination therapy in the treatment of T-cell acute lymphoblastic leukemia (T-ALL): multi-antigen-targeted chimeric antigen receptor T cells (CAR-T) followed by engineered immune effector cytotoxic T cells (CTLs) and immune modified dendritic cell vaccine (DCvac). This approach is aimed to achieve NGS MRD negativity in T-ALL patients, which can identify a very low risk of relapse and define patients with possible long-term remission without further treatment.",[27],[68,99,100,101],"CAR T","CTL","DC vaccine",{"date":77,"type":41},{"date":104,"type":41},"2026-06-01",{"date":106,"type":20},"2030-12-31",{"name":83,"class":48},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":123,"locationsCount":84},"100365058","phase-1-multi-car-t-cell-therapy-targeting-cd7-positive-malignancies-100365058","NCT04033302","Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies","A Multi-Center Study of Multiple CAR T Cell Therapy for CD7-positive Hematological Malignancies","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. Confirmed expression of CD7 or additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry.\n3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \\> 3 months.\n4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg\u002FdL.\n5. Hgb≥80g\u002FL.\n6. No cell separation contraindications.\n7. Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n2. Active bacterial, fungal or viral infection not controlled by adequate treatment.\n3. Known HIV or hepatitis C virus (HCV) infection.\n4. Pregnant or nursing women may not participate.\n5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial.\n6. Previous treatment with any gene therapy products.\n7. Patients, in the opinion of investigators, may not be able to comply with the study.",{"count":59,"type":20},[23,24],"The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cell therapy against CD7-positive hematological malignancies using CD7 specific CAR T cells. The study also aims to learn more about the function of CD7 CAR T cells and their persistence in patients of hematological malignancies.",[63,64,65,66],[68,69,70,71,99,73],{"date":77,"type":41},{"date":104,"type":41},{"date":106,"type":20},{"name":83,"class":48},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":131,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":84},"100461517","phase-2-daratumumab-for-chemotherapy-refractory-minimal-residual-disease-in-t-cell-all-100461517","NCT05289687","Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL","A Phase II Study of Daratumumab-Hyaluronidase for Chemotherapy-Relapsed\u002FRefractory Minimal Residual Disease (MRD) in T Cell Acute Lymphoblastic Leukemia (T-ALL","Inclusion Criteria:\n\n* Patient must have documented T cell ALL and must be in first or later hematologic CR or CRi after a minimum of 2 blocks of intensive chemotherapy.\n* Patients in hematologic CR or CRi must have persistent or recurrent MRD ≥ 10-4.\n* Institution must have received central MRD status test results confirming persistent or recurrent MRD ≥ 10-4 by flow cytometry.\n* Patient may have undergone a prior allogeneic stem cell transplant, but patient may not have Grafts Versus Host Disease (GVHD) that requires ongoing immunosuppressive therapy. Patient may receive prednisone if the dose is ≤ 10 mg per day.\n* Patient must have an ECOG performance status 0-2.\n* All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 registration to rule out pregnancy.\n* Patients must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and continue to 3 months after the last dose of protocol treatment. Patients must also agree to abstain from donating sperm, even if they have had a successful vasectomy, or donating eggs while on study treatment and for 3 months after the last dose of protocol treatment.\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible.\n* Patient must have adequate organ and marrow function as defined below (these labs must be obtained ≤ 7 days prior to Step 1 registration).\n* Absolute neutrophil count (ANC) ≥ 750\u002FμL\n* Platelets ≥ 75,000\u002FμL\n* Total or Direct bilirubin ≤ 2 mg\u002FdL\n* AST(SGOT)\u002FALT(SGPT) ≤ 3.0 × institutional ULN\n* Creatinine ≤ 1.5 x institutional ULN or Creatinine Clearance \\> 30 ml\u002Fmin\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with prior CNS involvement are eligible as long as they do not have active CNS involvement at time of Step 1 registration.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n\nExclusion Criteria:\n\n-Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used","18 Years",{"count":133,"type":20},20,[24],"In this study, the investigators are hypothesizing that daratumumab-hyaluronidase will effectively treat T-ALL in patients who have persistent or recurrent MRD following treatment with chemotherapy.",[63],"2026-06-16",{"date":75,"type":41},{"date":140,"type":41},"2023-05-25",{"date":142,"type":20},"2027-06-30",{"name":144,"class":145},"Eastern Cooperative Oncology Group","NETWORK",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":84},"100632395","phase-1-venetoclax-dexamethasone-bortezomib-and-daratumumab-for-the-treatment-of-adolescent-and-young-adults-with-relapsed-or-refractory-t-cell-acute-lymphoblastic-leukemia-and-t-cell-acute-lymphoblastic-lymphoma-100632395","NCT07513129","Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young Adults With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And T-cell Acute Lymphoblastic Lymphoma","A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And Lymphomas","Inclusion Criteria:\n\n* Weight must be \\> or = to 40 kg\n* Patients must have histologically or cytologically confirmed relapsed or refractory T-ALL or TLBL.\n* Age ≥ 12 year to ≤ 30 years.\n* Lansky ≥60 for patients \\\u003C16, Karnofsky ≥60 for patients ≥ 16 years of age. (See Appendix I)\n* Baseline ejection fraction must be \\> 40% OR Shortening fraction \\>20%. Either can be used at the investigator's discretion.\n* Adequate hepatic function (direct bilirubin \\\u003C 1.5x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and\u002For ALT \\\u003C 5x ULN unless considered due to leukemic involvement, in which case direct bilirubin \\\u003C 3x ULN or AST and\u002For ALT \\\u003C 10x ULN will be considered eligible.\n* Adequate renal function (calculated creatinine clearance ≥ 30 mL\u002Fmin) unless related to disease as determined by PI.\n* In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of the prior therapy (whichever is shorter). Hydroxyurea and\u002For cytarabine (up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the PI.\n* Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted.\n* Patients may have received any of the study agents prior to enrollment in study if not previously provided in study combination.\n* For patients with history or evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.\n\nFor patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of active progression.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better as determined by PI.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion.\n\nExclusion Criteria:\n\n* Patients with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.\n* No investigational or commercial anti-cancer agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.\n* The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions:\n\n  i. intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia.\n\nPrevious CNS evaluation and intrathecal (IT) chemotherapy administered prior to consent can be considered as the Cycle 1 Day 1 IT chemotherapy, provided it was completed within 7 days of C1D1. ii. use of hydroxyurea or cytarabine for patients with rapidly proliferative disease.\n\niii. use of steroids for treatment of rapidly proliferative disease. iv. Investigational or commercial agent for supportive care may be used in consultation with the treating physician.\n\n* Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n* Patients with severe uncontrolled peripheral neuropathy significantly impairing motor or sensory function.\n* Patients with a concurrent second active malignancy under treatment.\n* Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.\n\nTesting is not required for patients without a known or suspected history.\n\n* Female subjects who are pregnant or breast-feeding.\n* Patient has an infection that is both active and uncontrolled.\n* History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition venetoclax, dexamethasone, bortezomib, daratumumab.","12 Years","30 Years",{"count":5,"type":20},[23],"This is an open-label, single institution, Phase 1 study of Venetoclax, Dexamethasone, Bortezomib, and Daratumumab for adolescent and young adult participants with relapsed or refractory T-ALL or T-LBL",[63,159],"Lymphoma","2026-06-15",{"date":162,"type":41},"2026-06-17",{"date":164,"type":41},"2026-06-05",{"date":166,"type":20},"2031-12-31",{"name":168,"class":48},"M.D. Anderson Cancer Center",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":57,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100609931","phase-1-novel-unedited-allo-cell-therapy-for-high-risk-t-cell-malignancies-using-cd7-specific-car-t-cells-100609931","NCT07220993","Novel Unedited Allo Cell Therapy For High Risk T-Cell Malignancies Using CD7-Specific Car T Cells","Novel Unedited Allo Cell Therapy For High Risk T-Cell Malignancies Using CD7-Specific Car Expressed On T Cells (NEO-CRIMSON)","Procurement Inclusion Criteria:\n\n• Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LL), or T-non-Hodgkin Lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia\u002Flymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK\u002FT cell lymphoma, Mycosis fungoides\u002F Sezary Syndrome Stage IIB or higher))\n\nAND\n\nRelapsed post-allogeneic related donor (matched, mismatched, or haploidentical) HSCT from whom allogeneic CD7.CAR T cells can be manufactured.\n\nAND\n\n* suitable for allogeneic hematopoietic stem cell transplant (HSCT)\n* with a suitable donor identified by a FACT accredited transplant center\n* willing to proceed to transplant if the CD7.CAR treatment induces complete remission and the patient\u002Fdonor remain suitable candidates.\n\nUsing NMDP donor assessment criteria, suitability is defined as \"during the search process, a donor is fit to proceed to the next step- whether high-resolution or confirmatory HLA testing OR donor work-up.\" Documentation of suitability will be confirmed by the investigator prior to treatment.\n\n\\*For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated.\n\n* CD7-positive tumor (≥20% CD7 positive blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry\u002FPathology laboratory).\n* Age ≤75 years old.\n* Hgb ≥ 7.0 g\u002FdL (can be transfused)\n* Life expectancy greater than 12 weeks\n* Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation.\n* Informed consent explained to, understood by and signed by patient\u002FLAR. Patient\u002FLAR given copy of informed consent.\n\nProcurement Exclusion Criteria:\n\n* Active infection requiring antibiotics\n* Active infection with HIV\n* History of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervical cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry.\n\nPrior HSCT Donor Procurement Criteria:\n\n• Donor must be prior hematopoietic stem cell transplant donor for patient relapsed post-allogeneic HSCT who meets patient screening eligibility criteria and has signed screening informed consent.\n\nPrior transplant donors will be screened with the standard blood bank donor questionnaire, medical history, and testing for infectious disease markers (IDMs; which may be pending at the time of blood collection). Medical history may be obtained by the patient's primary\u002Freferring transplant team if collection is being done remotely. The physician assessment, donor questionnaire, and IDMs will be reviewed by the principal investigator or appropriate designee to confirm\u002Fprovide final eligibility determination and documented in the donor's medical record.\n\n• Informed consent explained to, understood by and signed by donor\u002FLAR. Donor\u002FLAR given copy of informed consent.\n\nTreatment Inclusion Criteria:\n\n• Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LL), or T-non-Hodgkin Lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia\u002Flymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK\u002FT cell lymphoma, Mycosis fungoides\u002F Sezary Syndrome Stage IIB or higher))\n\nAND\n\nRelapsed post-allogeneic related donor (matched, mismatched, or haploidentical) HSCT AND prior allogeneic donor available to donate blood for allogeneic CD7.CAR T-cell manufacture\n\nAND\n\n* suitable for allogeneic hematopoietic stem cell transplant (HSCT)\n* with a suitable donor identified by a FACT accredited transplant center\n* willing to proceed to transplant if the CD7.CAR treatment induces complete remission and the patient\u002Fdonor remain suitable candidates.\n\nUsing NMDP donor assessment criteria, suitability is defined as \"during the search process, a donor is fit to proceed to the next step- whether high-resolution or confirmatory HLA testing OR donor work-up.\" Documentation of suitability will be confirmed by the investigator prior to treatment.\n\n\\*For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated.\n\n* CD7-positive tumor (≥20% CD7+ blasts or tumor cells by flow cytometry or immunohistochemistry (tissue) assessed in a CLIA certified Flow Cytometry\u002FPathology laboratory.\n* Age ≤75 years old.\n* Bilirubin less than 3 times the upper limit of normal.\n* AST less than 5 times the upper limit of normal.\n* Estimated GFR ≥ 50 mL\u002Fmin.\n* Pulse oximetry of \\> 90% on room air\n* Karnofsky or Lansky score of ≥ 60%.\n* Recovered from acute toxic effects of prior treatments (i.e. chemotherapy) at least one week before entering this study.\n* ≥ 60 days post-allogeneic HSCT at time of treatment.\n* Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation.\n* Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.\n* Informed consent explained to, understood by, and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\nTreatment Exclusion Criteria:\n\n* Currently receiving any investigational agents or having received any tumor vaccines within the previous 4 weeks.\n* History of hypersensitivity reactions to murine protein-containing products.\n* Pregnant or lactating.\n* Tumor in a location where enlargement could cause airway obstruction (per investigator discretion).\n* Clinically significant infection or uncontrolled viral reactivation of EBV, CMV, Adv, BK-virus, or HHV-6.\n* Evidence of acute GVHD \\> Grade II or active chronic GVHD \\> mild global severity score.\n* Currently taking corticosteroids for therapy at a dose of \\>0.5mg\u002Fkg prednisone equivalent.\n* Patients who have received immunosuppressive treatment (IST) for GVHD within 28 days of infusion.\n* Patients who have received donor lymphocyte infusion (DLI) within 28 days of infusion\n* Any of the following cardiac criteria: Uncontrolled atrial fibrillation\u002Fflutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion; LVSF\\\u003C30% or LVEF\\\u003C50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA III or IV. \\*Study requires cardiac echocardiography confirmation of absence of these conditions within 12 months of treatment.\n* CNS abnormalities: Presence of CNS-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3 (unless negative by the Steinherz\u002FBleyer algorithm); Presence of any CNS disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia\u002Fhemorrhage within the past 12 months, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.",{"count":177,"type":20},27,[23],"Patients eligible for this study have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer).\n\nThe body has different ways of fighting infection and disease. This study combines two different ways of fighting disease with antibodies and T cells. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, or T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and T cells have been used to treat cancer; they have shown promise, but have not been strong enough to cure most patients.\n\nT cells can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person.\n\nThe antibody used in this study is called anti-CD7. This antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD7. CD7 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD7 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor.\n\nIn the laboratory, investigators have also found that T cells work better if they also add proteins that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells grow better and last longer in the body, thus giving the cells a better chance of killing the leukemia or lymphoma cells.\n\nIn this study, investigators attach the CD7 chimeric receptor with CD28 added to it to T cells. Investigators will then test how long the cells last. These CD7 chimeric receptor T cells with CD28 are investigational products not approved by the Food and Drug Administration.",[64,181,63],"T-non-Hodgkin Lymphoma",[183,184,185,63],"Autologous CAR T cells","T-cell acute lymphoblastic lymphoma","T-non-Hodgkin lymphoma","2026-05-14",{"date":188,"type":41},"2026-05-18",{"date":190,"type":41},"2026-05-12",{"date":192,"type":20},"2043-12",{"name":194,"class":48},"Baylor College of Medicine",2,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":203,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":221},"100555646","phase-2-a-phase-2-study-of-wu-cart-007-an-anti-cd7-allogeneic-car-t-cell-therapy-in-t-cell-acute-lymphoblastic-leukemia-and-lymphoblastic-lymphoma-t-rrex-100555646","NCT06514794","A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)","A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed\u002FRefractory Cell Acute Lymphoblastic Leukemia\u002FLymphoblastic Lymphoma (T-RRex)","Key Inclusion Criteria:\n\n* Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse\u002Frefractory or MRD positive\n* Age: Lower age limit of ≥ 6 months; adequate organ function\n* Eastern Cooperative Oncology Group (ECOG)\u002FKarnofsky Performance Status 0 or 1\u002F70 and above at Screening.\n\nKey Exclusion Criteria:\n\n* Prior treatment with any anti-CD7 therapy.\n* Patients with decompensated hemolytic anemia.\n* Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression. Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.","1 Year",{"count":205,"type":20},125,[24],"The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed\u002FRefractory (R\u002FR) T-Cell Acute Lymphoblastic Leukemia (T-ALL)\u002FLymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response",[63,209],"Lymphoblastic Lymphoma",[211],"CAR-T Therapy","2026-05-09",{"date":190,"type":41},{"date":215,"type":41},"2025-01-31",{"date":217,"type":20},"2028-12-30",{"name":219,"class":220},"Wugen, Inc.","INDUSTRY",15,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":203,"maxAge":131,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":232,"conditions":233,"keywords":236,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100546083","phase-2-adding-dasatinib-or-venetoclax-to-improve-responses-in-children-with-newly-diagnosed-t-cell-acute-lymphoblastic-leukemia-all-or-lymphoma-t-lly-or-mixed-phenotype-acute-leukemia-mpal-100546083","NCT06390319","Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)","SJALL23T: Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)","Inclusion Criteria:\n\n* Enrollment on INITIALL.\n* Age 1-18.99 years at the time of enrollment on INITIALL.\n* T-Acute lymphoblastic leukemia or lymphoblastic lymphoma or mixed phenotype acute leukemia\u002F lymphoma\n* No prior chemotherapy excluding therapy given on or allowed by INITIALL.\n* Patient has completed no more than 3 days of chemotherapy on INITIALL.\n* Direct bilirubin ≤ 1.5x the upper limit of normal for age\n* Alanine aminotransferase (ALT) ≤ 5x the upper limit of normal for age\n* Calculated glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73m\\^2 using the Bedside Schwartz equation OR creatinine below or equal to the maximum defined below:\n\n  * Age: 1 to \\\u003C 2 years - Maximum serum creatinine (mg\u002FdL): 0.6 (Male), 0.6 (Female)\n  * Age: 2 to \\\u003C 6 years - Maximum serum creatinine (mg\u002FdL): 0.8 (Male), 0.8 (Female)\n  * Age: 6 to \\\u003C 10 years - Maximum serum creatinine (mg\u002FdL): 1 (Male), 1 (Female)\n  * Age: 10 to \\\u003C 13 years - Maximum serum creatinine (mg\u002FdL): 1.2 (Male), 1.2 (Female)\n  * Age: 13 to \\\u003C 16 years - - Maximum serum creatinine (mg\u002FdL): 1.5 (Male), 1.4 (Female)\n  * Age: ≥ 16 years - Maximum serum creatinine (mg\u002FdL): 1.7 (Male), 1.4 (Female)\n\nExclusion Criteria:\n\n* Inability or unwillingness to give informed consent\u002F assent as applicable.\n* Patients with \\> Grade 2 neuropathy at the time of enrollment (participant with T-LLy only).\n* Documented malabsorption syndrome or any other condition that precludes receipt of oral medications.\n* Known HIV infection or active hepatitis B (defined as hepatitis B surface antigen-positive) or C (defined as hepatitis C antibody-positive).\n* Pregnant or lactating.\n* For patients of reproductive potential, unwillingness to use highly effective contraception for the duration of protocol therapy and for 90 days afterwards.\n* Receipt of a strong or moderate CYP3A4 inducer such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of protocol treatment.\n* Consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days of the start of protocol therapy.",{"count":230,"type":20},100,[24],"This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia.\n\nPrimary Objective\n\n* To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231.\n* To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231.\n\nSecondary Objectives\n\n* To assess the event free and overall survival of patients treated with this therapy.\n* To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.",[63,234,235],"T-cell Lymphoma","Mixed Phenotype Acute Leukemia",[237,238,239,63,234,240],"Newly Diagnosed","Children","Young Adults","Mixed Phenotype Acute Leukemia (MPAL)","2026-04-29",{"date":243,"type":41},"2026-05-01",{"date":245,"type":41},"2024-12-27",{"date":247,"type":20},"2033-12",{"name":249,"class":48},"St. Jude Children's Research Hospital",3,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":21,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100437182","phase-1-targeted-immunotherapy-after-myeloablative-tbi-based-conditioning--allohct-in-caya-with-high-risk-t-cell-all--lymphoma-100437182","NCT04972942","Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma","Phase I Trial of Targeted Immunotherapy With Daratumumab Following Myeloablative TBI-Based Conditioning and AlloHCT in Children, Adolescents and Young Adults With High Risk T-Cell Acute Lymphoblastic Leukemia and Lymphoma (ALLO-T-DART)","ALLO-T-DART","Inclusion Criteria:\n\n* 0-39yrs\n* T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy (including secondary malignancy)\n* Planned allogeneic stem cell transplantation with donor identified\n* Performance status ≥ 60%\n* Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\n* Meet organ function requirements\n* Signed IRB approved informed consent\n\nExclusion Criteria:\n\n* May not have had a prior autologous or allogenic stem cell transplant\n* May not have uncontrolled, systemic infection at the time of enrollment\n* Known allergies, hypersensitivity, or intolerance to mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients\n* Must not be pregnant or actively breast feeding\n* Seropositive for HIV, hepatitis B or hepatitis C\n* COPD\n* Asthma\n* Clinically significant cardiac disease","39 Years",{"count":59,"type":20},[23],"A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, adolescents, and young adults (CAYA) with high risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy).\n\nPre- and post-HCT NGS-MRD studies will be correlated with outcomes in children, adolescents, and young adults with T-ALL undergoing allogeneic HCT and post-HCT DARA treatment. The study will also evaluate T-cell repertoire and immune reconstitution prior to and following DARA post-HCT treatment and correlate with patient outcomes.",[63,264],"T-Cell Acute Lymphoblastic Lymphoma",[266,267,268,269],"immunotherapy","children","adolescents","young adults","2026-04-10",{"date":272,"type":41},"2026-04-15",{"date":274,"type":41},"2023-05-22",{"date":276,"type":20},"2028-09",{"name":278,"class":48},"New York Medical College",16,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":287,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":21,"phases":290,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":84},"100468156","phase-2-study-of-venetoclax-combined-with-azacitidine-regimen-in-newly-diagnosed-t-all-patients-100468156","NCT05376111","Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients","A Prospective, Multi-Center Study to Evaluate the Efficacy and Safety of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-cell Acute Lymphoblastic Leukemia Patients","Inclusion Criteria:\n\n1. Patients aged ≥ 15.\n2. Patients diagnosed with T-ALL according to 2016 WHO criteria for precursor lymphoid neoplasms.\n3. ECOG performance status score less than 3.\n4. Patients without serious heart, lung, liver, or kidney dysfunction.\n5. Ability to understand and voluntarily provide informed consent.\n\nExclusion Criteria:\n\n1. Patients who are allergic to the study drug or drugs with similar chemical structures.\n2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.\n3. Patients with uncontrolled active infection\n4. Patients with active bleeding.\n5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.\n6. Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.\n7. Liver dysfunction (total bilirubin \\> 1.5 times the upper limit of the normal range, ALT\u002FAST \\> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT\u002FAST \\> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \\> 1.5 times the upper limit of the normal value).\n8. Patients with a history of clinically significant QTc interval prolongation (male \\> 450 ms; female \\> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.\n9. Surgery on the main organs within the past six weeks.\n10. Drug abuse or long-term alcohol abuse that would affect the evaluation results.\n11. Patients who have received chemotherapy treatments related to the disease.","15 Years",{"count":289,"type":20},28,[24],"The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed T-ALL patients.",[63,293],"Recruiting",[295,296,68,297],"Venetoclax","Azacitidine","Newly diagnosed","2026-03-17",{"date":300,"type":41},"2026-03-19",{"date":302,"type":41},"2022-04-01",{"date":304,"type":20},"2026-12-01",{"name":306,"class":48},"The First Affiliated Hospital of Soochow University",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":16,"minAge":313,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":21,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":327,"locationsCount":84},"100559203","phase-2-a-phase-2-study-to-evaluate-efficacy-of-calaspargase-pegol-mknl-and-decitabine-combined-with-venetoclax-in-pediatric-adolescent-and-young-adult-patients-with-relapsedrefractory-t-cell-acute-lymphoblastic-leukemia-t-all-and-t--cell-lymphoblastic-lymphoma-t-lly-100559203","NCT06561074","A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed\u002FRefractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)","Inclusion Criteria:\n\n1. Pediatric, adolescent, or young adult patients who have relapse or refractory T-cell lymphoblastic leukemia (T-ALL) or T-Cell lymphoblastic lymphoma (T-LLy) according to 2017 WHO classification and NCCN v1 2021.\n2. Patients have adequate performance status (ECOG ≤2) for patients≥16 years old, Lansky score \\>50 for patients\\\u003C16 years old.\n3. Patients must be 1mo to 21 years of age at time of signing\u002For having proxy sign the informed consent.\n4. Patients with asymptomatic CNS disease are eligible (see also Exclusion Criterion #2 in section 4.2.)\n5. The following conditions are allowed on study: conditions requiring systemic glucocorticoid use, such as autoimmune disease, acute or chronic controlled graft versus host disease (GVHD) or severe asthma. Patients are also allowed up to 5 days of glucocorticoids as cytoreduction in combination with up to 3 doses of cyclophosphamide (200 mg\u002Fm2\u002Fday) are allowed as standard pre-phase treatment up to 1 day before start of study treatment or cytarabine up to 2gm\u002Fm2. This can also be discussed with PI.\n6. Patients must have adequate organ function and laboratory results (obtained within 14 days of enrolment:\n\n   1. Total serum bilirubin ≤1.5 x upper limit of normal (ULN). Patients with known Gilbert's syndrome may have a total bilirubin up to ≤3 x ULN.\n   2. Adequate renal function (creatinine clearance ≥ 30 mL\u002Fmin) unless related to disease.\n   3. Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤3 x ULN; ≤5 x ULN unless in case of suspected leukemic liver involvement\n   4. Amylase, Lipase and Triglycerides must be WNL prior to administration of calaspargase pegol-mknl. If the lab values are outside the normal range, the treating physicians can discuss dosing\u002Fenrolling per PI discretion.\n7. Females of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (β-HCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use one of the following effective contraception methods during the study and for 3 months following the last dose of study drug. Effective methods of birth control include:\n\n   1. Birth control pills, skin patches, birth control injections, implants (placed under the skin by a health care provider)\n   2. Intrauterine devices (IUDs) and intra-uterine hormone-releasing systems (IUS)\n   3. Condom\n   4. Abstinence\n   5. Bilateral tubal occlusion\u002Fligation or Bilateral tubal occlusion\u002Fligation by hysteroscopy with a hysterosalpingogram to confirm the procedure's success\n8. Males need to inform the doctor right away if the partner becomes pregnant or suspects pregnancy. While in this study and for 90 days after the last treatment the patient should not donate sperm for the purposes of reproduction. He will need to use a condom while in this study and for 90 days after the last treatment.\n9. Patients must have had at least 30 days between prior hematopoietic stem cell transplant and first dose of study drug.\n10. Patients able and willing to swallow tablets or use oral dispersible tablets. No liquid formulation is available.\n\nExclusion Criteria:\n\n1. Past or current history of a secondary or other primary tumor or a chronic myeloid leukemia (CML) blast crisis with exception of:\n\n   uratively treated non-melanomatous skin cancer, other primary solid tumor treated with curative intent and no known active disease present, and no treatment administered during the last 2 years\n2. Presence of clinically significant uncontrolled CNS pathology such as epilepsy, paresis, aphasia, stroke, severe brain injuries, organic brain syndrome, or psychosis.\n\n   Presence of the following are allowed: headaches, vomiting, nerve palsy\n3. Significant traumatic injury or major surgery (major surgery means opening of a body cavity, e.g., thoracotomy, laparotomy, laparoscopic organ resection, and major orthopedic procedures, e.g. joint replacement, open reduction, and internal fixation) within 14 days of scheduled dosing day 1.\n4. Male or female subjects of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with institution's standards.\n5. Patients with uncontrolled infections (viral, bacterial, or fungal) per PI's discretion. Infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable.\n6. Medical history of cardiovascular disease such as:\n\n   Clinically significant cardiac disease including congestive heart failure (NYHA class III or IV), arrhythmia or conduction abnormality requiring medication, or cardiomyopathy.\n7. Female patient who is pregnant or breastfeeding. Female patient who is considering becoming pregnant during the study; or within approximately 30 days after the last dose of venetoclax, 3 months after the last dose of calaspargase or 6 months after the last dose of decitabine. For decitabine and calaspargase, also see the study drugs product label for pregnancy precautions. Male patient who is considering fathering a child within approximately 30 days or donating sperm during the study, within approximately 90 days after the last dose to venetoclax, calaspargase and decitabine. For all study drugs, also see the relevant chemotherapy product label for not fathering a child and donating sperm.\n8. Patients may be excluded if they are currently enrolled in another ongoing clinical trial with investigational products\n9. Liver cirrhosis or other active severe liver disease or with suspected active alcohol abuse.\n10. Patients who are unable or unwilling to comply with all study requirements for clinical visits, examinations, tests, and procedures.\n11. If patient has not recovered from grade 2 clinically significant adverse effect(s)\u002Ftoxicity(s) of the previous therapy- (exception no grade 3 or higher peripheral neuropathy) from previous chemotherapy, surgery, radiation before the start of study drugs.\n12. Pancreatitis: Patients will be excluded in the presence of Grade 3 or 4 pancreatitis or if history of anaphylaxis or grade 3 pancreatitis from asparaginase.\n13. Other severe, uncontrolled acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the Investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and\u002For would make the patient inappropriate for enrollment into this study.\n14. History of serious hypersensitivity reactions including anaphylaxis to pegylated L-Asparaginase therapy.\n15. Known history of coagulopathy (e.g., hemophilia and know protein S deficiency).\n16. Active thromboembolic event(s) (i.e., symptomatic despite initiation of anti-coagulation therapy), or history of CNS thromboses.\n17. Patients should not have received the following within 7days prior to the first dose of study drug: Strong and moderate CYP3A inducers.\n18. Malabsorption syndrome or any other condition that precludes enteral administration.\n19. Has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit or used a strong or moderate CYP3A inhibitor within 2 days prior to the first dose of venetoclax.","1 Month","21 Years",{"count":316,"type":20},22,[24],"To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed\u002Frefractory T-ALL and T-LLy. The safety of this drug combination will also be studied.",[63,320],"T-Cell Lymphoblastic Lymphoma","2026-03-12",{"date":323,"type":41},"2026-03-16",{"date":325,"type":41},"2025-09-25",{"date":166,"type":20},{"name":168,"class":48},{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":16,"minAge":336,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":21,"phases":338,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":195},"100491497","phase-1-safety-and-efficacy-of-oc-1-therapy-in-patients-with-rr-t-allll-100491497","NCT05679895","Safety and Efficacy of OC-1 Therapy in Patients With R\u002FR T-ALL\u002FLL","Safety and Efficacy of hCD1a-CAR T (OC-1) Therapy, in Patients With Relapsed\u002FRefractory (R\u002FR) T-cell Acute Lymphoblastic Leukemia\u002FLymphoma (T-ALL\u002FLL","CARxALL","Inclusion Criteria\n\n1. Children older than 2 years or adults, male and female in both groups.\n2. Patients CD1a antigen blast expression ≥20% at inclusion, either immunophenotypically (flow cytometry) or histologically confirmed.\n3. R\u002FR CD1a-positive T-ALL\u002FLL patients defined as:\n\n   * Failure to achieve morphological complete remission (\\> 5% bone marrow blasts) or persistence of extramedullary disease after at least two cycles of chemotherapy.\n   * First or subsequent relapse, including morphologic or MRD-detectable (≥1x10-4 ) bone marrow and\u002For extramedullary relapses after at least one standard frontline therapy.\n   * Relapse after allogeneic haematopoietic stem cell transplantation (allo-HSCT).\n   * Primary refractoriness, defined as either morphologic persistence or detectable MRD (≥1x10-4 ) after at least two cycles of chemotherapy, making the patient not candidate for allo-HSCT.\n4. Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study.\n\nExclusion Criteria:\n\n1. Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), \\\u003C45%), pulmonary, liver, renal or CNS dysfunction.\n2. Allo-HSCT within a time frame \\\u003C3 months, or requiring continued immunosuppressive treatment for graft versus host disease (GvHD).\n3. Uncontrolled epilepsy or underlying central nervous system (CNS) severe disease.\n4. Active bacterial, fungal or viral infection not controlled by adequate treatment.\n5. Known HIV, active hepatitis B (HBV), or hepatitis C virus (HCV) infection.\n6. Women who are pregnant (urine\u002Fblood pregnancy test positive) or lactating.\n7. Severe illness or medical condition, which would not permit the patient to be managed according to the protocol.\n8. Suffering from a serious autoimmune disease or immunodeficiency disease.\n9. The patient participated in other experimental drug clinical trial within 6 weeks prior to OC-1 infusion.\n10. Other non-controlled concomitant neoplasms.","2 Years",{"count":133,"type":20},[23],"First in humans, exploratory, open-label, single-arm, multicentre, non-competitive, dose escalation study to assess the safety and efficacy of CD1a-CAR T therapy in patients with relapsed\u002Frefractory (R\u002FR) T-cell acute lymphoblastic leukemia\u002Flymphoma (T-ALL\u002FLL)",[63,341],"Lymphoblastic T-Cell Lymphoma",[343,344],"CAR-T-based therapies","CD1a","2026-03-09",{"date":347,"type":41},"2026-03-11",{"date":349,"type":41},"2023-01-31",{"date":351,"type":20},"2027-12",{"name":353,"class":220},"OneChain Immunotherapeutics",{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":21,"phases":364,"briefSummary":365,"conditions":366,"keywords":369,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":84},"100616059","phase-1-anti-ccr9-car-t-cells-for-t-cell-leukaemialymphoma-100616059","NCT07300683","Anti-CCR9 CAR T Cells for T Cell Leukaemia\u002FLymphoma","Fratricide-Resistant Autologous Chimeric Antigen Receptor T Cells Targeting CCR9 for the Treatment of T Cell Acute Lymphoblastic Leukaemia\u002F Lymphoma","FRACTALL","Key Inclusion Criteria:\n\n* Relapsed or refractory T-ALL\u002FT-LBL following at least one (≥18 years old) or two (\\\u003C18 years old) standard prior lines of combination cytotoxic therapy\n* CCR9-positive disease as assessed by flow cytometry\n* T-LBL patients only: Patients must have measurable disease\n* Agreement to have a pregnancy test, use adequate contraception (if applicable)\n* Written informed consent\n\nKey Exclusion Criteria:\n\n* ECOG performance score \\>2 (patients aged ≥10 years old) OR Lanksy score ≤50% (patients aged \\\u003C10 years old)\n* Stem Cell Transplant patients only: active significant acute GvHD or moderate\u002Fsevere chronic GvHD requiring immunosuppressive therapy and\u002For systemic steroids\n* Active CNS involvement of disease\n* Active hepatitis B, C or HIV infection\n* Oxygen saturation ≤90% on air\n* Bilirubin \\>3 x upper limit of normal\n* GFR \\\u003C30 ml\u002Fmin\n* Cardiac dysfunction\n* Patients receiving corticosteroids at a supraphysiological dose that cannot be discontinued\n* Known allergy to any component of the ATIMP\n* Any contraindications to lymphodepletion or to the use of cyclophosphamide or fludarabine as per local SmPC\n* Women who are pregnant or breastfeeding\n* Life expectancy \\\u003C3 months\n* Fulminant or rapidly progressive disease",{"count":363,"type":20},24,[23],"The goal of this clinical trial is to learn if anti-CCR9 CAR T cells (which will be made using the patient's own blood cells) are safe and which dose should be used in children and adults with T cell leukaemia and lymphoma.\n\nParticipants will:\n\n* have T cells collected from their blood and these T cells will be used to make the CAR-T cells in a specialized laboratory.\n* be admitted at the hospital a week before the CAR T cells infusion to receive a short course of chemotherapy drugs which prepare the body to receive the CAR T cells.\n* be given the CAR T cells into their vein.\n* stay in the hospital for a minimum of 2 weeks to be closely monitored\n* following discharge, participants will come to the clinic for check-ups (approximately 12 visits in the first two years)\n* during screening, treatment and follow up visits, participants will have physical examination, collection of blood samples and bone marrow biopsies and\u002For imaging tests (CT\u002FPET-CT scans) depending on their type of T-cell cancer.",[367,368],"T Cell Acute Lymphoblastic Leukemia","T Cell Lymphoblastic Lymphoma",[360,370,371,372],"Fratricide-Resistant","CCR9","CAR T cells","2025-12-17",{"date":375,"type":41},"2025-12-24",{"date":377,"type":41},"2025-11-11",{"date":379,"type":20},"2042-12",{"name":381,"class":48},"University College, London",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":203,"maxAge":18,"enrollmentInfo":389,"targetDuration":4,"studyType":21,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":406},"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":390,"type":20},80,[23,24],"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.",[63,394,395,396],"Acute Lymphoblastic Leukemia, in Relapse","Refractory Acute Lymphoblastic Leukemia","T-cell Malignancies","2025-11-21",{"date":399,"type":41},"2025-11-26",{"date":401,"type":41},"2024-03-22",{"date":403,"type":20},"2028-03-30",{"name":405,"class":48},"Beijing GoBroad Hospital",4,{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":57,"enrollmentInfo":415,"targetDuration":4,"studyType":21,"phases":417,"briefSummary":418,"conditions":419,"keywords":420,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":195},"100292059","phase-1-autologous-t-cells-expressing-a-second-generation-car-for-treatment-of-t-cell-malignancies-expressing-cd5-antigen-100292059","NCT03081910","Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen","Phase 1 Therapy With Manufactured Autologous T-Cells Expressing a Second Generation Chimeric Antigen Receptor (CAR) for Treatment of T-Cell Malignancies Expressing CD5 Antigen","MAGENTA","Procurement Inclusion Criteria for the Patient\n\nReferred patients (Group A - NOW CLOSED) or their previous HSCT donors (Group B) will initially be consented for procurement of blood for generation of the transduced ATL. Patient eligibility criteria at this stage include:\n\n1. Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia\u002Flymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK\u002FT cell lymphoma, Mycosis fungoides\u002F Sezary Syndrome Stage IIB or higher))\n\n   AND\n\n   Group A (auto arm - NOW CLOSED): Transplant naïve or relapsed post-allogeneic HSCT OR\n\n   Group B (allo arm): Relapsed post-allogeneic HSCT with previous HSCT donor from whom allogeneic MAGENTA CAR T cells can be manufactured\n\n   AND\n   * Suitable for allogeneic hematopoietic stem cell transplant (HSCT) with confirmation of an identified eligible allo-HSCT donor by FACT accredited institution\n   * Confirmation that the center plans to proceed with transplant if CD5.CAR treatment induces a complete remission.\n\n     * For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated.\n2. CD5-positive tumor (result can be pending at this time). \\> 50% CD5 + blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry\u002FPathology laboratory.\n3. Age ≤75 years old. NOTE: The first six (6) patients treated on the study should be adults (\\>18 yrs of age).\n4. Life expectancy of greater than 12 weeks.\n5. Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation\n6. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n7. Hgb greather than or equal to 7.0 g\u002FdL (can be transfused)\n8. If pheresis required to collect blood:\n\n   * Creatinine \\\u003C1.5 × upper limit normal\n   * AST \\\u003C1.5 × upper limit normal\n   * PT and APTT \\\u003C1.5 × upper limit normal\n\nProcurement Exclusion Criteria for the Patient (Group A)\n\n1. Active infection requiring antibiotics.\n2. Active infection with HIV\n3. History of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry.\n\nProcurement Inclusion Criteria for Normal Healthy Donor (Group B):\n\n1. Donor must be prior hematopoietic stem cell transplant donor for patients relapsed post-allogeneic HSCT. Prior transplant donors will be screened with the standard blood bank donor questionnaire, medical history, and testing for infectious disease markers (IDMs; which may be pending at the time of blood collection). Medical history may be obtained by the patient's primary\u002Freferring transplant team if collection is being done remotely. The physician assessment, donor questionnaire, and IDMs will be reviewed by the principle investigator or appropriate designee to confirm\u002Fprovide final eligibility determination and documented in the donor's medical record.\n2. Informed consent explained to, understood by and signed by donor\u002FLAR. Donor\u002FLAR given copy of informed consent.\n\nTreatment Inclusion Criteria\n\nPatients must meet the following eligibility criteria to be included for treatment:\n\n1. Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia\u002Flymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK\u002FT cell lymphoma, Mycosis fungoides\u002F Sezary Syndrome Stage IIB or higher))\n\n   AND\n\n   Group A (auto arm - NOW CLOSED): Transplant naïve or relapsed post-allogeneic HSCT OR\n\n   Group B (allo arm): Relapsed post-allogeneic HSCT with previous HSCT donor from whom allogeneic MAGENTA CAR T cells can be manufactured\n\n   AND\n   * Suitable for allogeneic hematopoietic stem cell transplant (HSCT) with confirmation of an identified eligible allo-HSCT donor by FACT accredited institution\n   * Confirmation that the center plans to proceed with transplant if CD5.CAR treatment induces a complete remission.\n\n     * For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated.\n2. CD5-positive tumor. \\>50% CD5 + blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry\u002FPathology laboratory.\n3. Age \\\u003C75 years old. NOTE: The first six (6) patients treated on the study should be adults (\\>18 yrs of age).\n4. Bilirubin less than 3 times the upper limit of normal.\n5. AST less than 5 times the upper limit of normal.\n6. Estimated GFR \\> 60 mL\u002Fmin.\n7. Pulse oximetry of \\> 90% on room air.\n8. Karnofsky or Lansky score of ≥ 60%.\n9. Recovered from acute toxic effects of prior chemotherapy at least one week before entering this study.\n10. ≥ 60 days post-allogeneic HSCT at time of treatment.\n11. Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation.\n12. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.\n13. Informed consent explained to, understood by, and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\nTreatment Exclusion Criteria\n\n1. Currently receiving any investigational agents or having received any tumor vaccines within the previous 6 weeks.\n2. History of hypersensitivity reactions to murine protein-containing products.\n3. Pregnant or lactating.\n4. Tumor in a location where enlargement could cause airway obstruction.\n5. Active infection with HIV.\n6. Clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV, Adv, BK-virus, or HHV-6.\n7. Evidence of acute GVHD \\> Grade II or active chronic GVHD \\> mild global severity score\n8. Currently taking corticosteroids for therapy of GVHD at a dose of \\>0.5mg\u002Fkg prednisone equivalent\n9. Patients who have received Immunosuppressive Treatment (IST) for GVHD within 28 days of infusion\n10. Patients who have received donor lymphocyte infusion (DLI) within 28 days of infusion\n11. 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\\\u003C30% or LVEF\\\u003C50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA III or IV (Confirmation of absence of these conditions within 12 months of treatment)\n12. CNS abnormalities: Presence of CNS-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3; History or presence of any CNS disorder such as a uncontrolled seizure disorder, cerebrovascular ischemia\u002Fhemorrhage within prior 6 months, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.",{"count":416,"type":20},54,[23],"Patients eligible for this study have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer).\n\nThe body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research combines two different ways of fighting disease, antibodies and T cells. Antibodies are proteins that protect the body from bacterial and other diseases. T cells, or T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and T cells have shown promise treating patients with cancers, but have not been strong enough to cure most patients.\n\nT lymphocytes can kill tumor cells but there normally are not enough of them. Some researchers have taken T cells from a person's blood, grown more in the lab then given them back to the person. In some patients who've had recent bone marrow or stem cell transplant, the number of T cells in their blood may not be enough to grow in the lab. In this case, T cells may be collected from their previous transplant donor, who has a similar tissue type.\n\nThe antibody used in this study, called anti-CD5, first came from mice that have developed immunity to human leukemia. This antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD5. CD5 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD5 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. In the lab, investigators have also found that T cells work better if stimulating proteins, such as one called CD28, are also added. Adding the CD28 makes the cells grow better and last longer in the body, giving them a better chance of killing the leukemia or lymphoma cells.\n\nIn this study investigators will attach the CD5 chimeric receptor with CD28 added to it to the patient's T cells or the previous bone marrow transplant donor's T cells. The investigators will then test how long the cells last. The decision to use the bone marrow transplant donor's T cells instead of the patient's will be based on 1) whether there is an available and willing donor and 2) the likelihood of the patient's T cells being able to grow in the lab. These CD5 chimeric receptor T cells with CD28 are investigational products not approved by the FDA.\n\nUPDATE: Please note that the Autologous Arm of this study is now closed.",[64,181,63],[183,184,181,63,421],"Allogeneic CAR T cells","2025-08-28",{"date":424,"type":41},"2025-09-04",{"date":426,"type":41},"2017-11-01",{"date":428,"type":20},"2040-09-01",{"name":194,"class":48},{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":16,"minAge":437,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":21,"phases":441,"briefSummary":442,"conditions":443,"keywords":446,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":84},"100568813","phase-2-demethylating-agents-combined-with-venetoclax-for-high-risk-t-cell-lymphoblastic-lymphomaleukemia-post-transplant-relapse-prevention-100568813","NCT06686108","Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma\u002FLeukemia Post-Transplant Relapse Prevention","Safety and Efficacy Study of Demethylating Agents With Venetoclax in Preventing Recurrence of High-risk T-cell Lymphoblastic Lymphoma\u002FLeukemia After Transplantation","Inclusion Criteria:\n\n* 1.14-55 years old, male,or female.\n* 2.Patients with allo-HSCT due to T-LBL\u002FALL, the donor type is not limited.\n* 3.ECOG score is 0-2 points.\n* 4.Blood routine: ANC ≥ 1.0 × 109\u002FL, PLT ≥ 50 × 109\u002FL.\n* 5.One of the following high-risk factors:\n* a. Age of initial diagnosis ≥ 35 years old.\n* b. Initial diagnosis of WBC ≥ 100 × 109\u002FL.\n* c. Initial diagnosis of LDH exceeding the upper limit of normal values.\n* d. Initial diagnosis of bone marrow involvement (blast cells ≥ 5%).\n* e. Initial diagnosis of a bulky in the mediastinum (longest diameter ≥ 10cm).\n* f. ETP immunophenotype.\n* g. During the induction chemotherapy process, 2 courses did not achieve partial remission and\u002For 4 courses did not achieve complete remission.\n* h. Residual lesions before transplantation: Flow cytometry analysis showed that the proportion of abnormal lymphoid cells in the bone marrow was greater than 0.01%; Positive detection of minimal residual lesions in molecular biology; PET-CT scan shows that residual lesions are still active.\n* i. Based on the ELN recommendation based on adult T-ALL: gene mutations involving myeloid related genes, RAS\u002FPI3K\u002FAKT, JAK\u002FSTAT signaling pathway, and epigenetics, such as FLT3, NRAS\u002FKRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations; t (8; 14) (q24; q11)\u002FMYC rearrangement; t (7; 19) (q34; p13)\u002FTCR-LYL1，TCR-MEF2C; del(5q) (q14).\n* j. High risk subgroups based on NGS definition: PI3K signaling pathway\u002FNRAS, KRAS\u002FTP53\u002FIKZF1\u002FDNTM3A\u002FIDH1, IDH2 gene mutation with or without NOTCH1, FBXW7\u002FPHF6\u002FEP300 gene mutation.\n\nExclusion Criteria：\n\n* 1.Central involvement during any course of the disease.\n* 2.Patients who have not achieved complete remission before transplantation.\n* 3.Identify those with available targeted drugs.\n* 4.For those who are resistant to BCL-2 inhibitors before transplantation, if the disease progresses during the application process, or if 3-4 courses of induction therapy containing BCL2 inhibitors do not improve.\n* 5.Individuals who are known to be allergic to demethylating drugs or venetoclax.\n* 6.Individuals with grade 2 or more degrees of active acute GVHD.\n* 7.Individuals with moderate to severe chronic GVHD.\n* 8.T-LBL\u002FALL relapse (flow cytometry abnormal lymphocyte cell proportion\\>0.01%, WT1 positive, fusion gene positive, or extramedullary recurrence), or transplant rejection, bone marrow donor cell chimerism\\\u003C95%.\n* 9.Blood routine: ANC\\\u003C1.0 × 109\u002FL or PLT\\\u003C50 × 109\u002FL.\n* 10.Combined with severe organ dysfunction; The ratio of aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) is more than 3 times the normal value or the normal value of direct bilirubin is more than 3 times; The endogenous creatinine clearance rate (Ccr) is less than 50mL\u002Fmin or 1.5 times the normal value of blood creatinine, regardless of whether hemodialysis treatment is used.\n* 11.Merge severe active infections.\n* 12.Pregnant or lactating women.\n* 13\\. Accepting other investigational drugs.\n* 14.According to the researchers' assessment, the patient may have complications that could lead to other dangers.","14 Years","55 Years",{"count":440,"type":20},59,[24],"This study is a prospective, phase II clinical trial with the primary objective of assessing the effectiveness of demethylating agents combined with venetoclax in the prevention of recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT) of high risk T-lymphoblastic lymphoma\u002Fleukemia (T-LBL\u002FALL) patients.",[63,444,445],"ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Relapse",[447,448,449],"T-cell lymphoblastic lymphoma\u002Fleukemia","relapse","allogeneic hematopoietic stem cell transplantation","2025-05-04",{"date":452,"type":41},"2025-05-07",{"date":454,"type":41},"2024-10-30",{"date":456,"type":20},"2028-10-30",{"name":458,"class":48},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":16,"minAge":336,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":21,"phases":470,"briefSummary":471,"conditions":472,"keywords":478,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":84},"100548367","phase-1-sequential-car-t-cells-therapy-for-cd5cd7-positive-t-cell-acute-lymphoblastic-leukemia-and-lymphoblastic-lymphoma-using-cd5cd7-specific-car-t-cells-100548367","NCT06420076","Sequential CAR-T Cells Therapy for CD5\u002FCD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5\u002FCD7-Specific CAR-T Cells","This is an Open, Single-arm, Clinical Study to Evaluate the Efficacy and Safety of Anti-CD7\u002FCD5 CAR-T Cells in the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL), ETP-ALL, and Lymphoblastic Lymphoma (TLBL).","BAH246","Inclusion Criteria:\n\n* Signed written informed consent; Patients volunteer to participate in the clinical trial;\n* Diagnosis is mainly based on the World Health Organization (WHO) 2008;\n* Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%;\n* Leukemic blast cells express CD7\u002FCD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%);\n* The expected survival period is greater than 12 weeks;\n* ECOG score ≤2;\n* Age 2-60 years old;\n* HGB≥70g\u002FL (can be transfused);\n* Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.\n\nExclusion Criteria:\n\n* Patients declining to consent for treatment\n* Prior solid organ transplantation\n* One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV;\n* History of severe pulmonary dysfunction diseases;\n* Severe infection or persistent infection cannot be effectively controlled;\n* Severe autoimmune disease or congenital immunodeficiency;\n* Active hepatitis;\n* Human immunodeficiency virus (HIV) infection;\n* Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).","90 Years",{"count":469,"type":20},60,[23,24],"Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5\u002FCD7 in patients with patients with relapsed or refractory T-ALL\u002FLBL\u002FETP-ALL. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.",[473,474,63,475,476,477],"T Cell Lymphoma","T Cell Leukemia","T-Cell Lymphoma of CNS","T Cell Prolymphocytic Leukemia","T Cell Childhood ALL",[479,480,73,481],"CAR-T","CD5","ETP-ALL","2024-11-10",{"date":484,"type":41},"2024-11-12",{"date":486,"type":41},"2024-07-10",{"date":488,"type":20},"2026-12-28",{"name":490,"class":48},"Essen Biotech"]