[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-chronic-myeloid-leukemia-bcr-abl1-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-chronic-myeloid-leukemia-bcr-abl1-positive":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100310864","phase-1-ha-1-t-tcr-t-cell-immunotherapy-for-the-treatment-of-patients-with-relapsed-or-refractory-acute-leukemia-after-donor-stem-cell-transplant-100310864",false,"NCT03326921","HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant","Phase I Study of Adoptive Immunotherapy With CD8+ and CD4+ Memory T Cells Transduced to Express an HA-1-Specific T Cell Receptor (TCR) for Children and Adults With Recurrent Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation (HCT)","Inclusion Criteria:\n\n* Subject age 0-80 years at the time of enrollment.\n* Subject must express HLA-A\\*0201\n* Subject must have the HA-1(H) genotype (RS\\_1801284: A\u002FG, A\u002FA)\n* Subject must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either:\n\n  * HLA-A\\*0201 positive and HA-1(H) negative (RS\\_1801284: G\u002FG) or\n  * HLA-A\\*0201 negative\n* Subjects who are currently undergoing or who previously underwent allogeneic HCT for\n\n  * Acute myeloid leukemia (AML) of any subtype\n  * Acute lymphoid leukemia (ALL) of any subtype\n  * Mixed phenotype\u002Fundifferentiated\u002Fany other type of acute leukemia, including blastic plasmacytoid dendritic cell neoplasm\n  * Chronic myeloid leukemia with a history of blast crisis and:\n\n    * With relapse or refractory disease (\\>= 5% marrow blasts, or circulating blasts) at any time after HCT\n    * With persistent rising minimal residual disease (defined as detectable disease by morphology, flow cytometry, molecular or cytogenetic testing but \\\u003C 5% marrow blasts by morphology, no circulating blasts on \\>= 2 of two consecutive tests), refractory or ineligible for treatment with tyrosine kinase inhibitors at any time after HCT\n  * Myelodysplastic syndrome (MDS) of any subtype\n  * Chronic myelomonocytic leukemia (CMML)\n  * Juvenile myelomonocytic leukemia (JMML)\n* Subjects must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative; parent or legal representative will be asked to consent for subjects younger than 18 years old\n* Subjects must agree to participate in long-term follow-up for up to 15 years if they are enrolled in the study and receive T cell infusion\n* Subjects who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol\n* A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA-1 TCR T cells may be required for subjects with low performance status\n\nDONOR SELECTION INCLUSION\n\n* Donor age \\>= 18 years\n* Donors must be able to give informed consent\n\nExclusion Criteria:\n\n* Medical or psychological conditions that would make the subject unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)\n* Fertile subjects unwilling to use contraception during and for 12 months after treatment\n* Subjects with a life expectancy of \\\u003C 3 months of enrollment from coexisting disease other than leukemia\n* Subjects who have ongoing grade IV acute GVHD or severe chronic GVHD following most recent transplant. Exception: the principal investigator (PI) may make an exception on a case-by-case basis to include such a subject if there is doubt surrounding the GVHD diagnosis and\u002For sustained significant improvement in GVHD severity\n* The presence of organ toxicities will not necessarily exclude subjects from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA-1 TCR T cells may be required\n\nDONOR SELECTION EXCLUSION\n\n* Donors who are human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection\n* Unrelated donor residing outside of the United States of America (USA) unless the donor screening, testing and leukapheresis occur at an National Marrow Donor Program (NMDP)-affiliated and qualified donor center and are facilitated by the NMDP","ALL","80 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) (HA-1 T TCR) T cells in treating patients with acute leukemia that persists, has come back (recurrent) or does not respond to treatment (refractory) following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1 is a protein that is present on the surface of some peoples' blood cells, including leukemia. HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize HA-1 markers on leukemia cells.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"Juvenile Myelomonocytic Leukemia","Recurrent Acute Biphenotypic Leukemia","Recurrent Acute Undifferentiated Leukemia","Recurrent Childhood Acute Lymphoblastic Leukemia","Recurrent Childhood Acute Myeloid Leukemia","Refractory Acute Lymphoblastic Leukemia","Refractory Adult Acute Lymphoblastic Leukemia","Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm","Recurrent Myelodysplastic Syndrome","Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm","Refractory Myelodysplastic Syndrome","Acute Undifferentiated Leukemia","Mixed Phenotype Acute Leukemia","Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive","Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Acute Lymphoblastic Leukemia","Recurrent Acute Myeloid Leukemia","Myelodysplastic Syndrome","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Acute Biphenotypic Leukemia","Chronic Myeloid Leukemia","Chronic Myelomonocytic Leukemia","Minimal Residual Disease","Recurrent Chronic Myelomonocytic Leukemia","Recurrent Mixed Phenotype Acute Leukemia","Leukemia","Chronic Myeloid Leukemia, BCR-ABL1 Positive",[56,57,58,53],"HA-1","TCR","Immunotherapy","RECRUITING","2026-05-15",{"date":62,"type":63},"2026-05-18","ACTUAL",{"date":65,"type":63},"2018-02-23",{"date":67,"type":20},"2028-07-16",{"name":69,"class":70},"Fred Hutchinson Cancer Center","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":71},"100605738","phase-1-anti-cd192022-chimeric-antigen-receptor-t-cells-tricar192022-t-cells-for-the-treatment-of-relapsed-or-refractory-non-hodgkin-lymphoma-acute-lymphoblastic-leukemia-and-chronic-lymphocytic-leukemia-100605738","NCT07166419","Anti-CD19\u002F20\u002F22 Chimeric Antigen Receptor T Cells (TriCAR19.20.22 T Cells) for the Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, and Chronic Lymphocytic Leukemia","Phase I Clinical Trial of Caring Cross Anti-CD19\u002F20\u002F22 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia) (C3PO)","Inclusion Criteria:\n\n* COHORT A: Subjects must have relapsed or refractory non-Hodgkin lymphoma with lesions ≤ 5 cm, indolent lymphomas, or chronic lymphocytic leukemia without Richter's transformation\n* COHORT B: Subjects with lymphoid blast crisis from chronic myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia with Richter's transformation, non-Hodgkin lymphoma with lesions \\> 5 cm and\u002For lymphoblastic lymphoma, or non-Hodgkin lymphoma with circulating lymphoma cells\n* Subjects must have been treated with at least two lines of therapy; subjects with prior commercial or investigational CAR T therapy targeting CD19, and\u002For CD20, and\u002For CD22 are permitted. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen\n* Note: Cohort assignment at discretion of principal investigator (PI) depending on patient disease\u002F history\n* Subjects with relapsed\u002Frefractory CLL after at least 2 prior lines of appropriate therapy and must have previously received an approved Bruton's tyrosine kinase (BTK) inhibitor and venetoclax\n* In subjects who had a prior autologous stem cell transplant for refractory high-grade B-cell lymphoma who relapse within 12 months of autologous stem cell transplant are eligible\n* Subjects with relapsed\u002Frefractory acute B-lymphoblastic leukemia who received at least 2 prior lines of appropriate therapy. Subjects are also eligible if they have failed or are ineligible for allogeneic stem cell transplant\n* Subjects with relapsed\u002Frefractory lymphoid blast crisis from prior chronic myeloid leukemia (CML) who received at least 2 prior lines of therapy (tyrosine kinase inhibitors, multiagent chemotherapy) or have failed or are ineligible for allogeneic stem cell transplant\n* The patient's lymphoid malignancy must be positive for CD19 and\u002For CD20 and\u002For CD22, either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral blood for circulating disease\n* Subjects with prior commercial or investigational CAR T therapy targeting CD19, and\u002For CD20, and\u002For CD22 are permitted if it has been at least 30 days since previous CAR T cell therapy and \\\u003C 5% of circulating levels of CD3+ cells express the prior CAR by flow cytometry\n* Subjects who received antibodies targeting CD19, or CD20, or CD22 are eligible\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Total bilirubin ≤ 1.5 times the institutional upper limit of normal\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) ≥ 3 x institutional upper limit of normal\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional upper limit of normal\n* Creatinine clearance more than or equal to 50 ml\u002Fmin calculated by the Cockcroft-Gault formula\n* Subjects must have adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air\n* Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 40% in the most recent echocardiogram\n* Absolute lymphocyte count ≥ 100\u002FuL; if white blood cell (WBC) is low and differential is not performed, CD3 count (helper\u002Fsuppressor) should be ≥ 100\u002Ful\n* Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the TriCAR19.20.22 T cell infusion\n\n  * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus)\n  * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptive s that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception\n* For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the TriCAR19.20.22 T cell infusion. Men must refrain from donating sperm during this same period\n  * With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the TriCAR19.20.22 T cell infusion to avoid potential embryonal or fetal exposure. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception\n\nExclusion Criteria:\n\n* Autologous transplant within 6 weeks of planned CAR-T cell infusion\n* Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months of planned CAR-T cell infusion and patients must be off immunosuppressive agents\n* Subjects with live vaccines given 28 days prior to lymphodepleting (LD) chemotherapy will be excluded\n* Active graft versus host disease\n* Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast). Subjects 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 (e.g. low Gleason score prostate cancer)\n* A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection\n* HIV-seropositive patients are allowable, however must be on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment to be eligible for this trial\n* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study\n* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy\n* Subjects with a positive hepatitis B core antibody or surface antigen are at high risk for hepatitis B virus (HBV) reaction and will require entecavir\u002Ftenofivir prophylaxis or serial hepatitis B (Hep) B polymerase chain reaction (PCR) monitoring at the direction of an infectious disease specialist. Duration of prophylaxis to correspond with detection of TriCAR19.20.22 T cells\u002Fviral vector copies in serum or continued evidence of B-cell aplasia such as reduced intravenous immunoglobulin (IVIG) levels. No antiviral prophylaxis is indicated with hepatitis C positivity with negative PCR\n* Subjects with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease\n* History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months","18 Years",{"count":19,"type":20},[23],"This phase I trial tests the safety, side effects and best dose of anti-CD19\u002F20\u002F22 chimeric antigen receptor (CAR) T cells (TriCAR19.20.22 T cells) and how well they work in treating patients with non-Hodgkin lymphoma, acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as CD19, CD20 and CD22, on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving TriCAR19.20.22 T cells may be safe, tolerable, and\u002For effective in treating patients with relapsed or refractory non-Hodgkin lymphoma, ALL and CLL.",[33,42,84,40,85,86,87,88,31,89,41,90,91,92,93],"Recurrent Chronic Lymphocytic Leukemia","Recurrent Indolent Non-Hodgkin Lymphoma","Recurrent Lymphoblastic Lymphoma","Recurrent Non-Hodgkin Lymphoma","Recurrent Transformed Chronic Lymphocytic Leukemia","Refractory Chronic Lymphocytic Leukemia","Refractory Indolent Non-Hodgkin Lymphoma","Refractory Lymphoblastic Lymphoma","Refractory Non-Hodgkin Lymphoma","Refractory Transformed Chronic Lymphocytic Leukemia","2026-04-10",{"date":96,"type":63},"2026-04-15",{"date":98,"type":63},"2026-01-14",{"date":100,"type":20},"2026-12-31",{"name":102,"class":70},"Ohio State University Comprehensive Cancer Center"]