[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-b-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-b-cell":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,79,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100458832","phase-3-a-study-of-pirtobrutinib-loxo-305-versus-ibrutinib-in-participants-with-chronic-lymphocytic-leukemia-cllsmall-lymphocytic-lymphoma-sll-100458832",false,"NCT05254743","A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)\u002FSmall Lymphocytic Lymphoma (SLL)","A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (BRUIN-CLL-314)","BRUIN-CLL-314","Inclusion Criteria:\n\n* Confirmed diagnosis of CLL\u002FSLL requiring therapy per iwCLL 2018 criteria\n* Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n* Adequate organ function\n\n  * Platelets greater than or equal to ≥ 50 x 10⁹\u002Fliter (L) or ≥30 x 10⁹\u002FL in participants with documented bone marrow involvement considered to impair hematopoiesis,\n  * Hemoglobin ≥8 grams\u002Fdeciliter (g\u002FdL) or ≥6 g\u002FdL in participants with documented bone marrow involvement considered to impair hematopoiesis\n  * Absolute neutrophil count ≥0.75 x 10⁹\u002FL or ≥0.50 × 10⁹\u002FL in participants with documented bone marrow involvement considered to impair hematopoiesis\n  * Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL\u002Fmin)\n\nExclusion Criteria:\n\n* Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment\n* Known or suspected central nervous system (CNS) involvement\n* A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease\n* Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\])\n* Significant cardiovascular disease including ejection fraction \\\u003C 40% and any grade ongoing atrial fibrillation or atrial flutter\n* Hepatitis B or hepatitis C testing indicating active\u002Fongoing infection, based on Screening laboratory tests\n* Active cytomegalovirus (CMV) infection\n* Active uncontrolled systemic bacterial, viral, or fungal infection\n* Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count\n* Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments\n* Ongoing inflammatory bowel disease\n* Previous treatment for CLL\u002FSLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent).\n\nPart 2: participants must be treatment naïve\n\n* Concurrent use of investigational agent or anticancer therapy except hormonal therapy\n* Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist\n* Use of \\> 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug\n* Vaccination with a live vaccine within 28 days prior to randomization\n* Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment\n* Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib","ALL","18 Years",{"count":20,"type":21},737,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL\u002FSLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL\u002FSLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.",[27,28,29,30],"Chronic Lymphocytic Leukemia","Leukemia, Lymphocytic","Leukemia, B-cell","Small Lymphocytic Lymphoma",[32,33,34,35],"BTKi","Hematologic Disease","Lymphoma, non-Hodgkin's","Lymphoma, B-cell","RECRUITING","2026-06-16",{"date":39,"type":40},"2026-06-17","ACTUAL",{"date":42,"type":40},"2022-07-22",{"date":44,"type":21},"2028-01",{"name":46,"class":47},"Loxo Oncology, Inc.","INDUSTRY",143,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100467132","phase-1-a-study-of-mgd024-in-patients-with-relapsed-or-refractory-hematologic-malignancies-100467132","NCT05362773","A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies","A Phase 1, First-in-Human, Dose Escalation Study of MGD024, a CD123 x CD3 Bispecific DART Molecule, in Patients With Select Relapsed or Refractory Hematologic Malignancies","Inclusion Criteria:\n\n* Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.\n* Participants with\n\n  * primary or secondary acute myeloid leukemia (AML) except acute promyelocytic leukemia,\n  * primary or secondary myelodysplastic syndrome (MDS) with prognostic score of \\>3 and \\\u003C20% bone marrow blasts,\n  * classical Hodgkin lymphoma (cHL),\n  * chronic myelogenous leukemia (CML),\n  * b-cell acute lymphocytic leukemia (B-ALL),\n  * hariy cell leukemia (HCL),\n  * advanced systemic mastocytosis (ASM), or\n  * blastic plasmacytoid dendritic cell neoplasm (BPDCM)\n* Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option.\n* Evidence of at least 20% of malignant cells with CD123 expression.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Life expectancy of at least 12 weeks.\n* Acceptable laboratory values, and heart function.\n* Continuing side effects of prior treatment are mild\n* Women and men of childbearing potential must agree to use highly effective forms of contraception throughout the study through 4 months after the last dose of MGD024.\n\nExclusion Criteria:\n\n* Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp).\n* Known involvement of central nervous system (CNS) by the disease under investigation.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient.\n* Systemic anti-cancer therapy, investigational therapy, corticosteroids or other immune suppressive drugs within 14 days of first dose\n* Vaccination with any live virus vaccine within 4 weeks prior to first dose. Inactivated annual influenza and SARS-CoV-2 vaccination are allowed.",{"count":57,"type":21},130,[59],"PHASE1","CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in participants with select blood cancers that have not responded to treatment with standard therapies or who have relapsed after treatment. The study is designed to determine the safety, tolerability, pharmacokinetics (affect of the body on the drug), pharmacodynamic (affect of the drug on the body), immunogenicity (development of antibodies against the drug), and preliminary anti-cancer effect of MGD024.\n\nParticipants will receive treatment with MGD024 in consecutive 28-day cycles for a study treatment period of up to 12 cycles (approximately 1 year) or until treatment or study discontinuation criteria are met. Response assessments will be performed after Cycle 1 and then after every even numbered cycle starting with Cycle 2 until progression or study treatment discontinuation. Participants will be checked for side effects throughout the study.",[62,63,64,29,65,66,67,68],"Leukemia, Acute Myeloid","Myelodysplastic Syndromes","Classical Hodgkin Lymphoma","Leukemia, Hairy Cell","Mastocytosis, Aggressive Systemic","Blastic Plasmacytoid Dendritic Cell Neoplasm","Chronic Myeloid Leukemia","2026-05-20",{"date":71,"type":40},"2026-05-22",{"date":73,"type":40},"2022-07-13",{"date":75,"type":21},"2027-05",{"name":77,"class":47},"MacroGenics",7,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":113},"100542604","phase-1-chimeric-antigen-receptor-treatment-targeting-cd70-seventy-100542604","NCT06345027","Chimeric Antigen Receptor Treatment Targeting CD70 (SEVENTY)","CASEY","Procurement Inclusion Criteria:\n\n1. Diagnosis of primary refractory or relapsed Acute Myeloid Leukemia (AML) with the exception of acute promyelocytic leukemia (APL). Patients with targetable mutations should have failed or be ineligible for targeted therapies (e.g. FLT3 inhibitors, IDH inhibitors or anti-CD33 drug conjugate)\n\n   OR\n\n   Patients with other relapsed or refractory CD70+ leukemia that would be considered an indication for allogeneic Hematopoietic Stem Cell Transplant (HSCT) if remission can be achieved. (CD19+ leukemia only: Patients must have failed or be ineligible to receive commercial CD19.CAR T cell treatments.)\n\n   Primary refractory or resistant disease, for purposes of procurement, defined as not achieving complete remission (CR) (i.e., a remaining blast count of 5% or more) after 1 to 2 cycles of intense induction therapy.\n\n   Relapse is defined as (1) hematologic relapse after complete remission based on bone marrow blasts \\>=5%, or reappearance of blasts in the blood, or development of extramedullary disease; (2) molecular relapse after minimal residual disease (MRD) negative, complete remission based on reoccurrence of MRD as assessed by RT-qPCR or by multi-parametric flow cytometry (MFC)\n2. CD70 positive leukemia with at least 26% CD70+ blasts by flow cytometry or immunohistochemistry (staining can be pending at time of procurement)\n3. Age ≤75 years. NOTE: The first three (3) patients treated on the study will be adults (≥18 years of age)\n4. Hemoglobin ≥ 7.0 g\u002FdL (can be transfused)\n5. If apheresis required to collect blood\n\n   * PT and aPTT \\\u003C1.5x ULN\n   * Serum Creatinine \\\u003C 2 x ULN\n   * AST \\\u003C 5 x ULN\n6. Informed consent\n\nProcurement Exclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia (APL)\n2. Active infection (bacterial, fungal, or viral) requiring ongoing treatment without improvement.\n3. Known active infection with HIV or HTLV (collected blood will be sent for HIV\u002FHTLV testing, separate testing prior to procurement not required). Patients with HIV are eligible if viral load is undetectable on therapy and CD4 count is \\>350 mm3.\n4. Active second cancer (except non-melanoma skin cancer or in situ breast cancer or cervical cancer) or other cancer treated ≤ 2 years prior to enrollment\n5. Ongoing treatment with immune suppression for prophylaxis\u002Ftreatment of GVHD including high dose steroids (e.g. prednisone equivalent \\> 0.5 mg\u002Fkg\u002Fday)\n\nTreatment Inclusion Criteria:\n\n1. Diagnosis of primary refractory or relapsed Acute Myeloid Leukemia (AML) with the exception of acute promyelocytic leukemia (APL) Patients with targetable mutations should have failed or be ineligible for targeted therapies (e.g. FLT3 inhibitors, IDH inhibitors, or anti-CD33 drug conjugate).\n\n   OR\n\n   Patients with other relapsed or refractory CD70+ hematological leukemias that would be considered an indication for allogeneic Hematopoietic Stem Cell Transplant (HSCT) if remission can be achieved. Patients with CD19+ malignancies must have failed or be ineligible to receive commercial CD19.CAR T cell treatments.\n\n   Primary refractory or resistant disease as defined by not achieving complete remission (CR) (i.e., a remaining blast count of 5% or more) after 1 to 2 cycles of intense induction therapy. Patients with no reduction in blast count after the first cycle or with p53 mutations without CR after the first cycle of intense induction therapy are also considered primary refractory.\n\n   Relapse is defined as (1) hematologic relapse after complete remission based on bone marrow blasts \\>=5%, or reappearance of blasts in the blood, or development of extramedullary disease; (2) molecular relapse after minimal residual disease (MRD) negative, complete remission based on reoccurrence of MRD as assessed by RT-qPCR or by multi-parametric flow cytometry (MFC)\n2. Confirmation from the patient's primary physician team of a suitable allogeneic hematopoietic stem cell transplant (HSCT) donor. OR Documentation that patient declines a potential subsequent HSCT)\n3. CD70 positive leukemia with at least 26% CD70+ cells by flow cytometry or immunohistochemistry (tissue)\n4. No systemic chemotherapy at least 2 weeks prior to treatment on study and must be recovered from all acute toxic effects of prior chemotherapy at time of treatment.\n5. Age ≤ 75 years. NOTE: The first three (3) patients treated on the study should be adults (≥18 years of age). Thereafter, a thorough review of the safety data will be performed and submitted to the FDA for approval prior to enrolling pediatric patients.\n6. Hemoglobin ≥ 7.0 g\u002FdL (can be transfused)\n7. Total bilirubin \\\u003C 3 times the upper limit of normal\n8. AST\u002FALT \\\u003C 5 times the upper limit of normal\n9. Estimated GFR ≥ 60ml\u002Fmin\n10. Pulse oximetry of \\> 90% on room air\n11. Karnofsky\u002FLansky score of ≥ 60%\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. Male partner should use a condom\n13. Informed consent obtained\n\nTreatment Exclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia (APL)\n2. Currently receiving any investigational agents or received any tumor vaccines within the previous 6 weeks.\n3. Pregnant or lactating.\n4. Uncontrolled infection with HIV, or HTLV. Patients with HIV are eligible if viral load is undetectable on therapy and CD4 count is \\>350 mm3.\n5. Clinically significant bacterial, fungal, or viral infection requiring ongoing therapy without improvement.\n6. Cardiac abnormalities: Cardiac echocardiography with LVEF\\\u003C50%; Cardiac dysfunction NYHA III or IV; Clinically significant pericardial effusion. Confirmation of absence of these conditions within 6 months of treatment.\n7. Presence of CNS disease: Defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3 or known CNS tumors\u002Fchloromas (repeat spinal tap within 4 weeks only required for leukemia patients with known CNS disease)\n8. Use of serotherapy with Campath or Anti-Thymocyte Globulin (ATG) within the last 28 days\n9. Use of Donor Lymphocyte Infusion (DLI) or other cellular therapy product within 28 days\n10. Acute GVHD ≥ Grade 2 or moderate to severe (formerly extensive) chronic GVHD\n11. High dose steroids \\>1 mg\u002Fkg within preceding 5 days or currently receiving \\>0.5mg\u002Fkg\u002Fday prednisone equivalent\n12. Hyperleukocytosis (WBC ≥ 50K) or rapidly progressive disease that in the estimation of the investigator would compromise the ability of the patient to complete the initial 6 weeks of the study","75 Years",{"count":88,"type":21},12,[59],"This study is for patients who have a type of blood cancer that expresses the protein CD70, which includes acute myeloid leukemia (AML), T-cell leukemia or B-cell leukemia (and the leukemia has come back or has not gone away after standard of care treatment).\n\nAs there are limited or no remaining standard treatments available to treat this cancer, subjects are being asked to volunteer to be in a gene transfer research study using special immune cells to create a specialized immune cell that will recognize a protein called CD70 that is expressed on the outside surface of the leukemia cells in a subject's body.\n\nThe body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines different ways of fighting disease by using T cells and \"arming\" them to recognize a specific protein on cancer cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. T cells by themselves have been used to treat patients with cancers and have shown promise, 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 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 protein used in this study is called anti-CD70. It has been developed from human CD27 on normal T cells, since it is the natural binding partner that can connect with CD70. This anti-CD70 protein sticks to leukemia cells when it binds to CD70. CD70 binders have been used to treat people with leukemia. For this study, anti-CD70 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 or \"CAR T cell\". The doctors then made another change to cause these T cells to kill any cell that has CD70. This causes the \"CAR T cells\" to kill blood cancer cells which are confirmed to have CD70.\n\nIn the laboratory, investigators have found that T cells work better if there are proteins added which stimulate T cells. The anti-CD70 (CD27) protein is unique because it can bind to CD70 on leukemia cells but also stimulates the T cells that express it. Adding the CD27 makes the cells grow better and may help them to last longer in the body, thus giving the cells a better chance of killing the leukemia cells.\n\nThese CD70 \"CAR\" T cells are investigational products not approved by the Food and Drug Administration.\n\nThe purpose of this study is to find a dose of CAR T cells that is safe, to learn what the side effects are and to see whether this therapy might help people with leukemia.",[92,29,93],"Leukemia, Myeloid, Acute","Leukemia, T-Cell",[95,96,97,98,99,100,101],"Leukemia","Acute myeloid","B cell","T cell","Blood cancer","Lymph gland cancer","CD70.CAR T-cells","NOT_YET_RECRUITING","2025-12-09",{"date":105,"type":40},"2025-12-16",{"date":107,"type":21},"2026-02",{"date":109,"type":21},"2042-04-01",{"name":111,"class":112},"Baylor College of Medicine","OTHER",2,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100440074","phase-1-trivalent-car-t-cell-in-acute-b-lineage-leukemia-tricar-all-100440074","NCT05010564","Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)","(H-49235) Trivalent Autologous T-Lymphocytes Co-Expressing Three Chimeric Antigen Receptors Targeting CD19, CD20 AND CD22 in Acute B-lineage Leukemia (TRICAR-ALL)","TRICAR-ALL","INCLUSION CRITERIA FOR PROCUREMENT:\n\n* Diagnosis of refractory or recurrent B cell Acute Lymphoblastic Leukemia (B-ALL) with expression of CD19, CD20 and\u002For CD22\n* Age between 1 and 25 years.\n* Life expectancy of ≥ 8 weeks\n* Weight ≥ 10 kg\n* Subjects ≥ 18 years of age must have the ability to give informed consent according to applicable regulatory and local institutional requirements. Legal guardian's consent must be obtained for subjects \\\u003C 18 years of age. Assent will be obtained from pediatric subjects and according to applicable regulatory and local institutional requirements. Adults with cognitive impairment who are unable to consent and those with Down's syndrome are also eligible for this protocol with consent\u002Fassent according to applicable regulatory and local institutional requirements.\n* The subject must discontinue all anti-cancer agents and, in the opinion of the investigator, has recovered from significant acute toxic effects of: a) Chemotherapy and biologic agents: All chemotherapy and biologic therapy not specifically mentioned below must be discontinued ≥ 7 days prior to collection, with the exception of intrathecal chemotherapy and maintenance chemotherapy being discontinued ≥ 72 hours prior to collection (for the subset of subjects who relapse during maintenance); b) Steroid use: All systemic corticosteroid therapy (unless physiologic replacement dosing of ≤ 12mg\u002Fm2\u002Fday hydrocortisone or equivalent) must be discontinued ≥ 3 days prior to collection; c) Tyrosine Kinase Inhibitor (TKI) use: All TKIs must be discontinued ≥ 3 days prior to collection; d) Hydroxyurea: must be discontinued ≥ 1 day prior to collection; e) Prior CAR-T cell therapy: must be at least 30 days from most recent CAR-T cell infusion prior to collection; f) Immunotherapy directed at leukemia: No antibodies within three (3) half-lives prior to collection (or within 4 weeks) whichever is shorter. This includes Antithymocyte globulin (ATG) formulations; g) Anti T-cell Antibodies, Alemtuzumab: must be discontinued ≥ 8 weeks prior to collection\n\nEXCLUSION CRITERIA FOR PROCUREMENT:\n\n* Active malignancy other than disease under study\n* Presence of active severe infection, defined as: a) positive blood culture within 48 hours of collection, OR; b) known history of active viral infections including infection with HIV, hepatitis B, hepatitis C or HTLV\n* Primary immunodeficiency syndrome\n* Pregnant or breastfeeding\n* Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol\n\nINCLUSION CRITERIA FOR T-CELL THERAPY\n\n* Diagnosis of refractory or recurrent B cell Acute Lymphoblastic Leukemia (B-ALL) with expression of CD19, CD20 and\u002For CD22 and meeting any of the following conditions:\n* B-ALL with no prior history of allo-HCT with one of the following:\n\n  1. Second or subsequent marrow relapse\n  2. First marrow relapse if, at the end of re-induction, bone marrow showing ≥ 0.01% blasts by morphology \\&\u002For flow cytometry\n  3. Primary refractory disease defined by having ≥ 5% blasts in the marrow by morphology and\u002For minimal residual (MRD) testing after 2 or more separate induction regimens (which may include CD19-targeting therapies)\n  4. Subject has an indication for allo-HCT but deemed ineligible (including subjects who have persistent MRD prior to allo-HCT)\n  5. CD19(+) or CD19(-) relapse or refractory ALL after infusion of CD19- CAR-T cells or other CD19-targeting immunotherapies. CD20 or CD22 expression is required for CD19(-) B-ALL.\n\nOr\n\n* B-ALL recurrent after allo-HCT defined as having ≥ 0.01% marrow disease\n* Available transduced T-cells with ≥ 15% expression of CD19, CD20 or CD22 CAR by flow cytometry.\n* Prohibited medications - washout periods (prior to CAR-T cell product infusion): Radiation therapy including TBI and cranial radiation. Local\u002Fpalliative radiation excluded: ≥ 4 weeks. Cytotoxic chemotherapy: ≥ 2 days. Tyrosine Kinase Inhibitors: ≥ 7 days\n* Total Bilirubin: ≤ 3X upper limit of normal (ULN) for age OR conjugated bilirubin ≤ 2mg\u002Fdl, except in subjects with Gilbert's syndrome where a total bilirubin level of up to 5.3 mg\u002FdL will be acceptable\n* ALT ≤ 5 times upper limit of normal\n* Adequate renal function defined as serum creatinine that is ≤ maximum based on age\u002Fgender (as indicated below) or Creatinine clearance or GFR (as measured or estimated by Cockcroft Gaultor Schwartz) ≥ 50 mL\u002Fmin\u002F1.73m2\n\nMaximum Serum Creatinine (mg\u002FdL):\n\nMale and Female: Age 1 to \\\u003C 2 years: 0.6 Male and Female: Age 2 \\\u003C 6 years: 0.8 Male and Female: Age 6 to \\\u003C 10 years: 1.0 Male and Female: Age 10 to \\\u003C 13 years: 1.2 Male: Age 13 to \\\u003C16 years 1.5 Female: Age 13 to \\\u003C16 years 1.4 Male: Age equal to or \\> 16 years 1.7 Female: Age equal to or \\> 16 years 1.4\n\n* Pulse oximetry of ≥ 90% on room air\n* Left ventricular fractional shortening (LVFS) ≥ 28% confirmed by echocardiogram or left ventricular ejection fraction (LVEF) ≥ 45% confirmed by echocardiogram (MUGA or MRI heart may replace echocardiogram).\n* Lansky score of ≥ 50% (age ≥1 and \\\u003C 16 years) or Karnofsky score of ≥ 50% (age ≥ 16 years). Refer to appendix IV\n* Donor lymphocyte infusions (DLI) completed \\> 6 weeks prior to CAR-T cell infusion\n* Subjects of childbearing\u002Ffathering potential must agree to use highly effective contraception (see Appendix IIII for acceptable forms of contraception) from the time of initial T cell infusion through 12 months following the last T cell infusion\n* Subjects \\> 18 years of age must have the ability to give informed consent according to applicable regulatory and local institutional requirements. Legal guardian's consent must be obtained for subjects \\\u003C 18 years of age. Assent will be obtained from pediatric subjects and according to applicable regulatory and local institutional requirements. Adults with cognitive impairment who are unable to consent and those with Down's Syndrome are also eligible for this protocol with consent\u002Fassent according to applicable regulatory and local institutional requirements.\n\nSubject willing to participate in long term follow up for up to 15 years.\n\nEXCLUSION CRITERIA FOR T-CELL THERAPY\n\n* Pregnant or lactating\n* Presence of any condition that, in the opinion of the PI or designee, would prevent the patient from undergoing protocol-based therapy.\n* If history of allogeneic Hematopoietic Cell transplantation (allo-HCT):\n\n  * active GVHD: acute GVHD \\>\u002F= Grade 2 or chronic GVHD, extensive global severity score, OR\n  * actively taking corticosteroids for management of GVHD at a dose of \\> 0.5 mg\u002Fkg\u002Fday of prednisone equivalent\n  * receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to T-cell infusion.\n* Acute symptomatic CNS pathology requiring active medical intervention, including paresis, aphasia, cerebrovascular ischemia\u002Fhemorrhage, severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder. Subjects with chronic, stable neurological conditions such as non-febrile seizure disorder controlled on anti-epileptic medication and without seizure activity within 3 months may be eligible. Subjects with a history of an isolated seizure episode of ≥ 4 weeks (including methotrexate neurotoxicity) without an underlying epileptic disorder are eligible.","12 Months","25 Years",{"count":125,"type":21},38,[59],"This is a gene transfer study for patients with a type of blood cancer called Acute Lymphoblastic Leukemia (ALL) that has come back or has not gone away after treatment.\n\nThe body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise but have not been strong enough to cure most patients. For example, T lymphocytes can kill cancer cells but there normally are not enough of them to kill all the cancer 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 targets CD19, CD20 and CD22. This antibody sticks to ALL cells because of a substance on the outside of these cells called CD19, CD20 and\u002For CD22. For this study, the antibody to CD19, CD20 and CD22 has been changed so that instead of floating free in the blood, it is now joined to the T cells. When T-cells contain an antibody that is joined to them, they are called chimeric antigen receptor- T cells or CAR-T cells.\n\nIn the laboratory, we have also found that T cells work better if we also add proteins that stimulate them. One such protein is called 4-1BB. Adding the 4-1BB molecule makes the cells grow better and last longer in the body, giving them a better chance of killing the leukemia cells. In this study we are going to attach the CD19\u002FCD20\u002FCD22 chimeric receptor that has 4-1BB added to the patient's T cells. We will then test how long the cells last.\n\nThese T cells, called \"TRICAR-ALL\" T cells are investigational products not approved by the Food and Drug Administration (FDA) outside the context of a clinical trial.",[129],"Leukemia, B-Cell",[131,132,133,134,135,136],"Relapsed or refractory B-Cell Leukemia","TRICAR ALL T-Cells","Cyclophosphamide","Fludarabine","immunotherapy","immune effector cell","2025-11-11",{"date":139,"type":40},"2025-11-13",{"date":141,"type":40},"2023-07-18",{"date":143,"type":21},"2040-03-29",{"name":111,"class":112},1]