[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukemia-refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukemia-refractory":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,76],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100430143","phase-1-study-of-cd19-allogeneic-memory-t-cell-therapy-for-relapsedrefractory-cd19-leukemia-100430143",false,"NCT04881240","Study of CD19 Allogeneic Memory T-cell Therapy for Relapsed\u002FRefractory CD19+ Leukemia","A Phase I Study Evaluating Allogeneic Memory T Cells Engineered to Express Chimeric Antigen Receptors Specific for CD19 for the Treatment of Pediatric and Young Adult Patients ≤ 21 Years of Age With Relapsed or Refractory CD19-Positive Leukemia","Inclusion Criteria Eligibility Criteria for Donors: Apheresis and Manufacturing\n\n* Age ≥ 18 years old\n* At least single haplotype matched (≥ 3\u002F6) family member\n* HIV negative\n* For females of child bearing age: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment AND Not lactating with intent to breastfeed\n* Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance\n\nFor Cohort A only, identified recipient with relapsed and\u002For refractory CD19-positive leukemia\n\nFor Cohort B only, iIdentified recipient with relapsed and\u002For refractory CD19-positive leukemia who is not suitable to receive autologous CD19-CAR T-cell therapy as defined by the following:\n\n* Relapsed and\u002For refractory disease despite prior treatment with autologous CD19- CAR T-cell therapy\n* History of prior autologous leukapheresis failure\n* History of prior autologous CAR T-cell manufacturing failure\n* Unable to undergo autologous leukapheresis in the opinion of the study PI(s): examples may include - patient small size\u002Flow weight, inadequate T-cell counts, rapidly progressive leukemia, clinical status not amenable to apheresis\n\nEligibility Criteria for Patients: Treatment\n\n* Age ≤ 21 years old\n* Relapsed and\u002For refractory CD19-positive leukemia\\*:\n\n  * Refractory disease (defined as any of the following):\n\n    * Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission\n    * Refractory disease despite salvage therapy\n  * Relapsed disease (defined as any of the following):\n\n    * 2nd or greater relapse\n    * Any relapse after allogeneic hematopoietic cell transplantation (HCT)\n    * 1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and\u002For unsuitable for HCT\n\nCD19-positivity confirmed within 2 months and after receipt of any CD19-directed therapy\n\n* Patient cohorts:\n\n  * Cohort A: patient has previously received a HCT from the selected CAR T-cell donor\n  * Cohort B - patient has NOT previously received a HCT from the selected CAR T-cell donor.\n* For Cohort B only, not suitable to receive autologous CD19-CAR T-cell therapy as defined above in Criteria: Eligibility Criteria for Donors: Apheresis and Manufacturing\n* Detectable medullary CD19-positive leukemia\n* Estimated life expectancy of ≥ 8 weeks\n* Karnofsky or Lansky performance score ≥ 50\n* No CNS-3 disease or any level of detectable leukemia in CNS with associated neurologic symptoms\n* If history of allogeneic HCT (regardless of donor type), prior to planned CAR T-cell infusion, must meet the following criteria:\n\n  * ≥ 3 months from HCT\n  * have recovered from prior HCT therapy\n  * have no evidence of active GVHD within prior 2 months\n  * have not received a donor lymphocyte infusion (DLI) within the 28 days prior to planned CAR T-cell infusion\n* Adequate cardiac function: left ventricular ejection fraction ≥ 40% or shortening fraction ≥ 25% (function may be supported by pharmacologic therapy)\n* EKG without evidence of clinically significant arrhythmia\n* Adequate renal function: creatinine clearance or radioisotope GFR 50 ml\u002Fmin\u002F1.73m2 (GFR 40 ml\u002Fmin\u002F1.73m2 if \\\u003C 2 years of age)\n* Adequate pulmonary function: forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing\n* Total bilirubin ≤ 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age\n* No history of HIV infection\n* No evidence of severe, uncontrolled bacterial, viral or fungal infection\n* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy\n* For females of child bearing age:\n\n  * Not pregnant with negative serum or urine pregnancy test ≤ 7 days prior to enrollment AND Not lactating with intent to breastfeed\n* If sexually active, agreement to use birth control until 6 months after CAR T-cell infusion\n* No history of hypersensitivity reactions to murine protein-containing products\n* Not receiving systemic steroids therapy exceeding the equivalent of 0.5 mg\u002Fkg\u002Fday of methylprednisolone ≤ 7 days prior to CAR T-cell infusion\n* Not receiving systemic therapy ≤ 14 days prior to CAR T-cell infusion, which will interfere with the activity of the CAR T-cell product in vivo (in the opinion of the study PI(s))\n* Not receiving intrathecal chemotherapy ≤ 7 days prior to CAR T-cell infusion\n\nExclusion Criteria:\n\nNA","ALL","21 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase I clinical study evaluating the safety and maximum tolerated dose of a novel CAR T-cell product: allogeneic memory (CD45RA- negative) T-cells expressing a CD19-specific CAR 41BBz (CD19-CAR.CD45RA- negative T-cells) for the treatment of patients ≤ 21 years old with relapsed and\u002F or refractory CD19-positive leukemia.\n\nPrimary Objective\n\nTo determine the maximum tolerated dose (MTD) and characterize the safety profile and dose-limiting toxicities (DLTs) of treatment with allogeneic CD19-CAR.CD45RA-negative T-cells in pediatric, adolescent and young adult patients ≤ 21 years of age, with relapsed and\u002For refractory CD19-positive leukemia.\n\nSecondary Objectives\n\n* To evaluate the anti-leukemic activity of allogeneic CD19-CAR.CD45RA-negative T-cells.\n* To determine rates and severity of graft-versus-host-disease (GVHD) after treatment with allogeneic CD19-CAR.CD45RA-negative T-cells.\n\nExploratory Objectives\n\n* To study the expansion, persistence and phenotype of allogeneic CD19-CAR.CD45RA-negative T-cells.\n* To characterize the cytokine profile in the peripheral blood and CSF after treatment with allogeneic CD19-CAR.CD45RA-negative T-cells.\n* To assess whether allogeneic CD19-CAR.CD45RA-negative T-cells acquire functional versus exhaustion-associated epigenetic programs.\n* To determine immune reconstitution post treatment, and the clonal structure and endogenous repertoire of allogeneic CD19-CAR.CD45RA-negative T-cells and relate inferred specificity to CAR response profiles.\n* To characterize incidence and mechanisms of relapse post-therapy with allogeneic CD19-CAR.CD45RA-negative T-cells.",[26,27,28],"Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphoblastic Leukemia, Refractory","Pediatric ALL","RECRUITING","2026-05-20",{"date":32,"type":33},"2026-05-26","ACTUAL",{"date":35,"type":33},"2024-02-14",{"date":37,"type":20},"2028-07-01",{"name":39,"class":40},"St. Jude Children's Research Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":41},"100621498","mb-cart191-in-relapsedrefractory-acute-lymphoblastic-leukemia-100621498","NCT07371403","MB-CART19.1 in Relapsed\u002FRefractory Acute Lymphoblastic Leukemia","MB-CART19.1 in Patients With Relapsed\u002FRefractory CD19-positive B Cell Acute Lymphoblastic Leukemia: A Feasibility Study","Inclusion Criteria:\n\n* Age ≥ 1 year as long as if deemed fit by treating investigator\n* CD19 expression must be detected (≥20%) on the malignant cells by flow cytometry.\n* Patients with relapsed or refractory disease with \\>5% blasts in the bone marrow after at least one frontline and one salvage chemotherapy regimen. For patients with Philadelphia-positive disease, a second generation or higher TKI must have been utilized in one of the treatment lines.\n* Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active graft vs host disease, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.\n* Estimated life expectancy \\> 12 weeks\n* Karnofsky or Lansky (age dependent) performance score ≥ 60\n* Patients and\u002For parents must give their written informed consent\u002Fassent.\n* CNS and\u002For testicular involvement are allowed, only if cleared and in the presence of systemic involvement.\n\nExclusion Criteria:\n\n* Rapidly progressive, uncontrolled disease as assessed by the treating physician and\u002For principal investigator.\n* Persistent extramedullary disease.\n* Isolated CNS and\u002For testicular disease.\n* Current autoimmune disease, or history of autoimmune disease with potential CNS involvement\n* Active hepatitis B, C or HIV\n* Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)\n* History of an additional malignancy (≤ 3 years) other than non-melanoma skin cancer or carcinoma in situ.\n* Pulmonary function: Patients with pre-existing severe lung disease (FEV1 or FVC \\\u003C 65%) or an oxygen requirement of \\>28% O2 FiO2 or active pulmonary infection.\n* Cardiac function: Left ventricular ejection fraction \\\u003C50% by echocardiography\n* Renal function: Creatinine clearance \\\u003C50 mL\u002Fmin\u002F1.73 m2\n* Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT \\> 5 times upper limit of normal, unless due to leukemic liver infiltration as determined by the investigators.\n* Pregnant or breast-feeding females\n* Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing (\\\u003C0.5 mg\u002Fkg\u002Fday of methylprednicone), tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis, Fludarabine\u002Fclofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, blinatumomab) or investigational drugs or donor lymphocyte","1 Year",{"count":51,"type":20},12,[53],"NA","Single-arm, prospective, open-label feasibility study evaluating the technical and operational feasibility of manufacturing autologous CD19-directed CAR-T cells (MB-CART19.1) at the point of care for the treatment of relapsed or refractory B-ALL in pediatric and adult patients.",[56,57,58,59,60],"Acute Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia Recurrent","Acute Lymphoblastic Leukemia Refractory","Acute Lymphoblastic Leukemia Not Having Achieved Remission","Acute Lymphoblastic Leukemia With Failed Remission",[62,63,16,64,65,66],"CAR-T","MB-CART19.1","acute lymphoblastic leukemia","relapsed acute lymphoblastic leukemia","refractory acute lymphoblastic leukemia","2026-03-24",{"date":69,"type":33},"2026-03-25",{"date":71,"type":20},"2026-02",{"date":73,"type":20},"2029-01",{"name":75,"class":40},"King Hussein Cancer Center",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":41},"100493470","phase-1-clinical-trial-using-car--t-cells-for-treatment-of-patients-with-refractory-or-relapsed-cd19-positive-b-lymphoid-malignancies-100493470","NCT05705570","Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies","A Phase I Clinical Trial Using Genetically Engineered Autologous T Cells to Express Chimeric Antigen Receptor (CAR) for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies","CARTHIAE-1","Inclusion Criteria:\n\n1. Subjects must have relapsed or refractory ALL, lymphoma or CLL treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.\n\n   Subjects with Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ALL) subjects are eligible if they progressed, had stable disease or relapsed after two lines of therapy, including tyrosine kinase inhibitors (TKIs).\n\n   Subjects with DLBCL must have progressed, had SD, or recurred after initial treatment regimens that include an anthracycline and an anti-CD20 monoclonal antibody.\n\n   Subjects with transformed FL, MZL, or CLL\u002FSLL must have progressed, had SD or recurred with transformed disease after initial treatment for DLBCL.\n\n   Subjects who relapse ≥12 months after therapy should have progressed after autologous transplant or been ineligible for autologous transplant.\n2. 2\\. The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.\n3. Age 2 to 70 years.\n4. Performance status: Adult Subjects: ECOG ≤ 2 for patients ≥ 16 years; Subjects \\\u003C 16 years of age: lansky ≥ 50%\n5. Normal Organ and Marrow Functioning (supportive treatment is allowed according to institutional standards, i.e. filgrastim, transfusion)\n\n   • Total Bilirubin ≤ 2; AST (SGOT) ≤ 5 times the upper limit of normal; ALT (SGTP) ≤ 5 times the upper limit of normal; Serum creatinine ≤ 1.5; Pulse oximetry \\>91% on room air; No dyspnea or mild dyspnea (≤ Grade 1); Forced expiratory volume in 1 s (FEV1) ≥50% or carbon monoxide diffusion test (DLCO) ≥50% of predicted level; Left ventricular ejection fraction ≥ 45% confirmed by echocardiogram; Subjects must have the following hematologic function parameters: Neutrophils \\> 1000\u002FuL; Absolute Lymphocyte Count \\> 100\u002FuL; Platelets ≥ 50,000\u002FL Patient should not be excluded if change of the above parameters due to spinal cord disease infiltration;\n6. Prior therapy wash-out - At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory\u002Fstimulatory immune checkpoint therapy, which requires 5 half-lives, Blinatumomab with 4 months prior CAR-T infusion.\n7. For women of reproductive potential: use a highly effective contraceptive for at least 1 month prior to screening and agree to use a method during study participation and for an additional 4 months after CAR T-cell administration has ended.\n8. Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Autologous transplant within 6 weeks of planned CAR-T cell infusion;\n2. History of allogeneic stem cell transplant 4 months prior CAR T cell infusion.\n3. Use of immunosuppression therapy;\n\n   • Patients must have completed immunosuppression therapy; Systemic corticosteroid therapy must be stopped more than 72 hours after infusion; Systemic drugs for graft-versus-host disease should be withheld at least 4 weeks prior to infusion;\n4. Presence of graft-versus-host disease Grade ≥ 2;\n5. Receiving CAR T cell treatment outside of this protocol;\n6. Active central nervous system or meningeal involvement by tumor. Subjects with untreated brain metastases\u002FCNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast-enhanced MRI imaging for at least 90 days prior to registration.\n7. History of active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast).\n8. HIV infection; HTLV\n9. 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.\n10. 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.\n11. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy\n12. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n13. Serious and\u002For potentially fatal medical conditions\n14. Patients 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.\n15. History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.\n16. Hypersensitivity against any drug or its ingredients\u002Fimpurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory lymphodepletion protocol, pre-medication for infusion, rescue medication\u002Fsalvage therapies for treatment related toxicities;","2 Years","70 Years",{"count":87,"type":20},30,[23],"This is a phase l, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL\u002FCLL (Cohort 3).",[26,58,91,92,93,94],"B-cell Lymphoma Recurrent","B-cell Lymphoma Refractory","Chronic Lymphocytic Leukemia Recurrent","Chronic Lymphocytic Leukemia Refractory",[96,97],"CAR T cell","CD19+ B-cell Malignancies","2025-09-22",{"date":100,"type":33},"2025-09-25",{"date":102,"type":33},"2023-02-07",{"date":104,"type":20},"2028-12-01",{"name":106,"class":40},"Nelson Hamerschlak"]