[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-t-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-t-cell":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100629216","phase-1-safety-and-efficacy-of-gya01-cart84-in-relapsedrefractory-rr-acute-myeloid-leukemia-aml-and-acute-lymphoblastic-t-leukemia-patients-t-all-100629216",false,"NCT07471789","Safety and Efficacy of GYA01 (CART84) in Relapsed\u002FRefractory (R\u002FR) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL).","Phase I\u002FIIa Clinical Trial With Dose Escalation to Evaluate Safety and Efficacy of the Infusion of CART84 in Relapsed\u002FRefractory (R\u002FR) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL).","Inclusion Criteria:\n\n1. Age 18 years or older at the time of signing the informed consent.\n2. Willing and able to give written, informed consent to the current study.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Diagnosed with AML or T-ALL with ≥5% blasts in BM and\u002For PB at screening, without any approved therapeutic alternative and one of the following:\n\n   1. Primary refractory disease (not achieving CR\u002FCRi after more than two cycles of induction chemotherapy).\n   2. Second relapse or beyond.\n   3. Refractory relapse after at least 1 line of salvage therapy.\n   4. Relapsed or refractory disease after allogeneic transplant provided the CART84 infusion occurs at least 3 months after the stem cell transplant.\n5. Documentation of CD84 expression on leukemic blasts in the BM and in peripheral blood, or other tissues if blasts are present, as assessed by flow cytometry at screening.\n6. For T-ALL patients: diagnosed with T-ALL exhibiting a double-negative (CD4- CD8-) immunophenotype, or patients with CD4+ and\u002For CD8+ T-ALL with no detectable blasts in peripheral blood.\n7. Availability of an appropriate HSCT donor, either related (haploidentical HLA matching or HLA identical sibling donor) or unrelated, if available within the required timeframe (days 30-90 post-CART84 infusion). If an unrelated donor is selected, it is highly recommended to have an haploidentical HLA matched donor identified and evaluated as a backup.\n8. For females of childbearing potential (defined as \\\u003C24 months after last menstruation or not surgically sterile), a negative serum or urine pregnancy test must be documented at screening, prior to pre-conditioning and confirmed before receiving the first dose of study treatment.\n9. For females who are not postmenopausal (\\\u003C24 months of amenorrhea) or who are not surgically sterile (absence of ovaries and\u002For uterus), commitment to the use of 2 methods of contraception, comprising of one highly effective method of contraception together with a barrier method, during the treatment period and for at least 12 months after the last dose of study treatment.\n10. Male participants must agree to use 2 acceptable methods of contraception (one by the patient - usually a barrier method), and one highly effective method by the patient's partner during the treatment period and for at least 12 months after the last dose of study treatment.\n11. Adequate renal, hepatic, pulmonary, and cardiac function defined as:\n\n    1. Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤2.5 x ULN (upper limit of normal).\n    2. Creatinine clearance (as estimated by the Cockcroft Gault formula) ≥50 mL\u002Fmin.\n    3. Total bilirubin ≤2 x ULN, except in patients with Gilbert's syndrome, who must have normal direct bilirubin.\n    4. Left ventricular ejection fraction (LVEF) ≥45% (or ≥institution's lower limit of normal) confirmed by ECHO or MUGA.\n    5. Baseline oxygen saturation \\>92% on room air.\n\nExclusion Criteria:\n\n1. Isolated extramedullary (EM) disease.\n2. Females who are pregnant or lactating.\n3. For T-ALL patients: Patients with T-ALL exhibiting CD4+ and\u002For CD8+ immunophenotypes with detectable blasts in peripheral blood.\n4. History or presence of clinically relevant CNS pathology, such as epilepsy, paresis, aphasia, stroke within 3 months prior to enrollment, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.\n5. Clinically significant, uncontrolled heart disease (New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick-sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities, unless the patient has a pacemaker) or a recent (within 12 months) cardiac event.\n6. Patients with active, life-threatening bleeding.\n7. Presence of uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.\n8. Positive serological testing for human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis B core antibody (anti-HBc), and hepatitis C virus antibody. Patients who are positive for anti-HBc or hepatitis C antibody may be included if they have a negative PCR test within 6 weeks prior to initial IMP administration.\n9. History of autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 24 months, or any autoimmune disease with CNS involvement.\n10. History of other malignant neoplasms unless disease-free for at least 12 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed).\n11. Known history of concomitant genetic syndromes such as Fanconi anemia, Schwachman-Diamond syndrome, Kostmann syndrome, or any other known BM failure syndrome.\n12. Patients who have received a prior stem cell transplant less than 3 months prior to CART84 infusion.\n13. Active significant (overall Grade ≥II, Seattle criteria) acute graft-versus-host disease (GvHD) or moderate\u002Fsevere chronic GvHD (NIH consensus criteria) requiring systemic steroids or other immunosuppressants within 4 weeks of consent.\n14. The following medications are excluded:\n\n    1. Steroids: Therapeutic doses of corticosteroids (greater than 10 mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CART84 administration. However, physiological replacement, topical, and inhaled steroids are permitted.\n    2. Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis and CART84 infusion.\n    3. Allogeneic cellular therapy: Any donor lymphocyte infusions must be completed \\>2 weeks prior to leukapheresis and not repeated thereafter.\n    4. Graft-versus-host disease therapies: Any drug used for the treatment of GvHD must be stopped \\>2 weeks prior to leukapheresis and not repeated thereafter.\n    5. Treatment with any T cell-lytic or toxic antibody (e.g. alemtuzumab) within 6 months prior to leukapheresis.\n    6. Intrathecal therapy within 2 weeks prior to starting pre-conditioning chemotherapy.\n15. If the patient participated in another experimental clinical trial within 1 month prior to CART84 infusion.\n16. Inability to tolerate leukapheresis.\n17. Patients who, in the opinion of the Investigator, may not be able to understand or comply with the safety monitoring requirements of the study or unlikely to complete all protocol-required study visits or procedures, including follow-up visits.","ALL","18 Years",{"count":19,"type":20},33,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This Phase I\u002FIIa clinical study is testing an experimental treatment called GYA01 (CART84) for people with acute myeloid leukemia (AML) or T-cell acute lymphoblastic leukemia (T-ALL) whose disease has come back after treatment (relapsed) or did not respond to treatment (refractory).\n\nGYA01 (CART84) is a type of CAR T-cell therapy. In this approach, a participant's own T cells (a type of immune cell) are collected and changed in a laboratory to help them better recognize and attack leukemia cells. The modified cells GYA01 (CART84) are then given back to the participant through an infusion into a vein.\n\nThe study is being done to:\n\nFind a dose that can be given safely (Phase I) by treating small groups of participants with increasing dose levels and carefully monitoring side effects.\n\nLook for early signs that GYA01 (CART84) may help control AML or T-ALL (Phase IIa).\n\nParticipants will be closely monitored for side effects and for changes in their leukemia after the infusion, and followed over time to understand safety and possible benefit.",[27,28],"Acute Myeloblastic Leukaemia","Leukemia, T-Cell",[30,31,32,33,34,35,36,37,38],"CART84","CART","AML","T-ALL","CD84","CAR-T","Cell Therapy","Gene Therapy","GYA01","RECRUITING","2026-03-10",{"date":42,"type":43},"2026-03-13","ACTUAL",{"date":45,"type":43},"2026-02-04",{"date":47,"type":20},"2031-02-04",{"name":49,"class":50},"Gyala Therapeutics","INDUSTRY",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":5},"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":60,"type":20},12,[23],"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.",[64,65,28],"Leukemia, Myeloid, Acute","Leukemia, B-cell",[67,68,69,70,71,72,73],"Leukemia","Acute myeloid","B cell","T cell","Blood cancer","Lymph gland cancer","CD70.CAR T-cells","NOT_YET_RECRUITING","2025-12-09",{"date":77,"type":43},"2025-12-16",{"date":79,"type":20},"2026-02",{"date":81,"type":20},"2042-04-01",{"name":83,"class":84},"Baylor College of Medicine","OTHER"]