[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-cell-acute-lymphoblastic-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-cell-acute-lymphoblastic-lymphoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,51,71,98,127],{"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":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100515709","phase-1-universal-4scar7u-targeting-cd7-positive-malignancies-100515709",false,"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.","ALL","6 Months","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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.",[27,28,29,30],"T-cell Acute Lymphoblastic Leukemia","T-cell Acute Lymphoblastic Lymphoma","Acute Myeloid Leukemia","NK Cell Lymphoma",[32,33,34,35,36,37],"T-ALL","TCL","AML","NK lymphoma","Universal CAR T","CD7","RECRUITING","2026-06-18",{"date":41,"type":42},"2026-06-23","ACTUAL",{"date":44,"type":42},"2023-10-31",{"date":46,"type":21},"2026-12-31",{"name":48,"class":49},"Shenzhen Geno-Immune Medical Institute","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":50},"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":20,"type":21},[24,60],"PHASE2","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.",[27,28,29,30],[32,33,34,35,64,37],"CAR T",{"date":41,"type":42},{"date":67,"type":42},"2026-06-01",{"date":69,"type":21},"2030-12-31",{"name":48,"class":49},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":18,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"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":79,"type":21},27,[24],"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.",[28,83,27],"T-non-Hodgkin Lymphoma",[85,86,87,27],"Autologous CAR T cells","T-cell acute lymphoblastic lymphoma","T-non-Hodgkin lymphoma","2026-05-14",{"date":90,"type":42},"2026-05-18",{"date":92,"type":42},"2026-05-12",{"date":94,"type":21},"2043-12",{"name":96,"class":49},"Baylor College of Medicine",2,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"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":20,"type":21},[24],"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.",[27,111],"T-Cell Acute Lymphoblastic Lymphoma",[113,114,115,116],"immunotherapy","children","adolescents","young adults","2026-04-10",{"date":119,"type":42},"2026-04-15",{"date":121,"type":42},"2023-05-22",{"date":123,"type":21},"2028-09",{"name":125,"class":49},"New York Medical College",16,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":18,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":97},"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":136,"type":21},54,[24],"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.",[28,83,27],[85,86,83,27,141],"Allogeneic CAR T cells","2025-08-28",{"date":144,"type":42},"2025-09-04",{"date":146,"type":42},"2017-11-01",{"date":148,"type":21},"2040-09-01",{"name":96,"class":49}]