[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"supratentorial-gliosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:supratentorial-gliosarcoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100438637","phase-1-phase-i-cb-nk-tgf-r2-nr3c1--in-rgbm-100438637",false,"NCT04991870","Phase I CB-NK-TGF-ßR2-\u002FNR3C1- in rGBM","A Phase I Clinical Trial With a Window-of-Opportunity Component of Engineered NK Cells Containing Deleted TGF-ßR2 and NR3C1 in Recurrent Grade 4 Astrocytoma (Glioblastoma)","Inclusion Criteria\n\n1. Signed and dated informed consent.\n2. Male or female participants aged ≥ 12 years on the day of signing informed consent.\n3. Has histologically confirmed supratentorial World Health Organization grade 4 recurrent astrocytoma to include recurrent IDH WT glioblastoma or gliosarcoma and recurrent IDHmutant grade 4 astrocytoma, and recurrent gliosarcoma with any prior number of recurrences, and who have received prior radiation and temozolomide therapy. Participants will be eligible if the original histology was lower-grade glioma grade 2 or 3 and a subsequent histological diagnosis of recurrent glioblastoma or IDH-mutant grade 4 astrocytoma is made.\n4. Karnofsky Performance Score (KPS) of \\>70 at trial entry. Lansky \\>70 at trial entry for patients less than 16.\n5. Must be at least 12 weeks from receiving conformal radiation, unless RANO criteria for early progression are met.\n6. A baseline brain MRI with Advance Brain Tumor Imaging (ABTI) must be obtained no more than 30 days prior to study registration\n7. Patients having undergone recent surgery are eligible so long as they are at least 3 weeks from resection or at least 1 week from stereotactic biopsy and recovered from any operative or perioperative complications.\n8. Adequate hematological function defined by white blood cell (WBC) count ≥ 3 x 10°9\u002FL with absolute neutrophil count (ANC) ≥ 1.5 x 10°9\u002FL, lymphocyte count ≥ 0.5 x 10°9\u002FL, platelet count ≥ 100 x 10°\u002FL, and Hgb ≥ 9 g\u002F dL (in absence of blood transfusion).\n9. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 x ULN, an AST level ≤ 2.5 x ULN, and an ALT level ≤ 2.5 x ULN, and INR ≤ 1.5 10. Adequate renal function defined creatinine ≥ 1.5 X upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL\u002Fmin for participant with creatinine levels \\> 1.5 X institutional ULN\n\n11\\. Female participant of childbearing potential should have a negative serum pregnancy test within 14 days (+\u002F-2 working days) of study registration.\n\n12\\. Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study and for 3 months after the last dose of study therapy. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n\n13\\. Male participants should agree to use 2 methods of highly effective contraception starting with the first dose of study therapy and for 3 months after the last dose of study therapy.\n\n14\\. For the surgical expansion group (Group 2): there must be at least 1 cm2 of contrast-enhancing disease that is considered resectable by the neurosurgeon.\n\nExclusion Criteria\n\n1. Has received prior therapy with Gliadel or bevacizumab.\n2. Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery.\n3. Is currently participating in or has participated in a study of cancer directed investigational agent or using an investigational device within 4 weeks since last dose of agent administration or device use, or is planning to continue or start treatment with Optune® during participation in this trial.\n4. Has known severe hypersensitivity to monoclonal antibodies, any history of anaphylaxis, or recent, within 5 months, history of uncontrolled asthma.\n5. Has a known history of Human Immunodeficiency Virus (HIV) (positive HIV 1\u002F2 antibodies); HTLV1 and\u002For HTLV2; active Hepatitis B (e.g., HbsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected). Patients with prior HBV vaccination (anti-HBs positive, HbsAg negative, anti-HBc negative) will NOT be excluded.\n6. Has a diagnosis of immunodeficiency or is receiving any immunosuppressive therapy within 7 days prior to study registration.\n7. Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 0.\n\n   1. Note: Participants with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n   2. Note: If participant received major surgery (other than craniotomy), they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n8. Has had prior radiation therapy less than 12 weeks prior to study registration, unless RANO criteria for early progression are met.\n9. Has had prior therapy with any antibody\u002Fdrug targeting T cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody within the last three months prior to study registration -.\n10. Has a known additional malignancy that is progressing or requires active treatment.\n\n    Exceptions include but are not limited to basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. Any exceptions must be discussed with the protocol PI.\n11. Has known gliomatous cerebri, extracranial disease, or tumor localized primarily to the brainstem or spinal cord.\n12. Brain midline shift greater than 0.5 cm or pending herniation seen on baseline MRI ABTI.\n13. Tumors larger than 5 cm at greatest diameter\n14. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Participants with vitiligo or resolved childhood asthma\u002Fatopy would be an exception to this rule. Participants that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.\n15. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.\n16. Has an active infection requiring systemic therapy or that in the opinion of the PI may interfere with the participant's participation, assessment of experimental treatment toxicity or increase the participant's risk of side effects.\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate in the opinion of the treating investigator.\n18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n19. Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit and through 3 months after last dose of the study treatment.\n20. Has received a live vaccine within 30 days prior to the first dose of trial treatment.\n21. Has a contraindication for undergoing MRIs.\n22. Has evidence of bleeding diathesis or coagulopathy.\n23. Is on full dose anticoagulants or antiplatelet therapy that cannot be held.\n24. Has significant hemorrhage on baseline MRI ABTI defined as \\>1 cm diameter of acute blood.\n25. Has received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).\n26. Has multicentric disease. Subject has multicentric GBM, defined as discrete sites of contrast enhancing disease without contiguous T2\u002FFLAIR abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2\u002FFLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted.\n\nTreatment will be up to 32 weeks in duration.\n\nThe number of cells administered will be based on gene editing efficiency. CB-NK-TGF-£\\]R2-\u002FNR3C1-cells will be administered via intraventricular injection via an Ommaya reservoir on day 0 and every 4 weeks y for up to 8 doses total in Group 1.\n\nSurgical patients in Group 2 will undergo intraventricular insertion of an Ommaya (day -14 to -\n\n1). They will then undergo IT injection via the Ommaya reservoir of CB-NK-TGF-£\\]R2-\u002FNR3C1-cells on day 0. Prior to planned tumor resection to occur between days 7-14. Every 4 week intraventricular injections of CB-NK-TGF-£\\]R2-\u002FNR3C1- cells will be administered for a total of 8 intraventricular treatments.\n\nIn the setting of any surgical complications following Ommaya placement, CB-NK-TGF-£\\]R2-\u002FNR3C1- cells may be delayed and administered once the patient is deemed stable by the neurosurgeon following Ommaya placement.\n\nTreatment will continue until tumor progression or intolerable toxicity, or a maximum of 8 intraventricular treatments with CB-NK-TGF-£\\]R2-\u002FNR3C1- cells whichever occurs first.","ALL","12 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial is to find out the best dose, possible benefits and\u002For side effects of engineered natural killer (NK) cells containing deleted TGF-betaR2 and NR3C1 (cord blood \\[CB\\]-NK-TGF-betaR2-\u002FNR3C1-) in treating patients with glioblastoma that has come back (recurrent). CB-NK-TGF-betaR2-\u002FNR3C1- cells are genetically changed immune cells that may help to control the disease.",[26,27,28],"Recurrent Gliosarcoma","Recurrent Supratentorial Glioblastoma","Supratentorial Gliosarcoma","RECRUITING","2026-01-22",{"date":32,"type":33},"2026-01-23","ACTUAL",{"date":35,"type":33},"2023-04-28",{"date":37,"type":20},"2027-01-31",{"name":39,"class":40},"M.D. Anderson Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":41},"100443327","phase-2-hstar-gbm-hematopoetic-stem-cell-hpc-rescue-for-gbm-100443327","NCT05052957","hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)","Phase II Trial O6-benzylguanine(BG) and Temozolomide(TMZ) Therapy of Glioblastoma Multiforme (GBM) With Infusion of Autologous P140K MGMT+Hematopoietic Progenitors to Protect Hematopoiesis","hSTAR GBM","Inclusion Criteria:\n\n* Patients with histologically confirmed, newly diagnosed, supratentorial glioblastoma or gliosarcoma who have undergone gross total tumor resection or near gross total resection (resection of \\>85% of enhancing tumor demonstrated by MRI) are eligible up to 35 days post-operatively. Patients with primarily infratentorial disease, or with multifocal,or leptomeningeal dissemination of disease will be excluded. In general, patients will not have \\> 1 cm residual measurable or evaluable disease after surgical tumor resection.\n* Patient must have unmethylated MGMT\n* Absence Of IDH1 or IDH2mutation on tumor tissue by a CLIA-approved immunohistochemistry or DNA sequencing test on local testing\n* Patients aged 18-75 years.\n* ECOG performance status 0-1or Karnofsky ≥ 70.\n* No myelosuppressive chemotherapy or hematopoietic cell transplantation prior to the diagnosis of GBM and no prior chemotherapy (including Gliadel BCNU wafers) for GBM\n* Life expectancy of at least 12 weeks.\n* No plan for hypofractionated radiation therapy\n* Adequate hematologic (absolute neutrophil count (ANC)≥ 1000\u002Fmm3, platelets ≥ 100,000\u002Fmm3, Hgb ≥ 9.5, hepatic (Bilirubin ≤ 2.0 mg\u002Fdl, AST and ALT less than or equal to 3 times institutional upper limit of normal, prothrombin time \\\u003C1.2 times normal), and renal (serum creatinine ≤ 2.0 mg\u002Fdl or Creatinine Clearance ≥ 60mL\u002Fmin\u002F1.73 m2for subjects with serum creatinine levels above institutional normal). These tests will be repeated within 2 weeks of treatment with BG and TMZ, and must meet the same criteria. -Post-operative steroids are i) tapered to ≤ 8mg dexamethasone\u002Fday(or equivalent)and ii) patient has been on a stable or decreasing steroid dose for the 7 days prior to enrollment\n* Patients of child-bearing potential must agree to using single barrier contraception.\n* Must be willing and able to understand provide informed consent.\n* Patient must have all sutures removed prior to registration\n* Patient must be considered to be clinically stable.\n* The subject will be identified as a candidate for an autologous transplant via an evaluation by a transplant physician per standard of care. Participants will be screened by their transplant physician and social work for a history of substance abuse per screening tool such as SIPAT. Any participant with positive screen for significant substance abuse will undergo evaluation and must have a treatment, management plan in place and must have formal review of medical team prior to initiation of transplant procedures.\n* No evidence of active infection.\n* Availability of 10unstained slides or FFPE sample of tumor for molecular or histopathological studies.\n* Negative screening for Hepatitis B, C and HIV\n\nExclusion Criteria:\n\n* Any known medical or hereditary condition associated with immunosuppression;orothermedical illness which may jeopardize patient safety.\n* Known history of HIV seropositivity. This exclusion is included for two reasons. First, there is evidence of decreased marrow reserve in HIV+ patients and antiviral treatment is associated with myelosuppression. Thus, drug treatment designed to be myelosuppressive may bemore toxic in this patient population. Second, extensive laboratory culturing of the bone marrow and peripheral blood progenitor cells is required. No preclinical samples which are HIV+ have been evaluated with the gene transfer modality proposed and thus the feasibility and safety of gene transfer and selection in HIV+ samples cannot yet be advocated. Such studies are planned so as to not preclude HIV+ patients in later studies.\n* Pregnant or lactating women. There is data to indicate that BCNU and TMZ is teratogenic and carcinogenic. Thus, its use in pregnant women would confer unnecessary risk to the fetus.\n* Patients with symptomatic pulmonary disease and other severe co-morbid respiratory conditions, including patients with active pulmonary infection and\u002For pulse oximetry \\\u003C 90% and a corrected DLCO \\\u003C 50% of predicted. However, subjects with a corrected DLCO in the range of 50-70% should have Pulmonologyclearance prior to intervention.\n* Patients with known diagnosis heart failure or cardiac insufficiency and an LVEF of \\\u003C 40%. History of acute coronary event including MI within 6 months prior to study enrollment.\n* Known history of cardiac arrhythmias including atrial fibrillation, tachyarrhythmiaor bradycardia.Inability to undergo repeated MRI evaluation; or allergy or intolerance of Gadolinium-containing contrast agent.\n* Active illicit drug use or diagnosis of alcoholism.\n* Prior diagnosis of any malignant disease with the exception of non-melanomatous skin cancer, or carcinoma in situof the cervix, bladder, prostate, or breast, unless patient has been disease-free\u002Fin remission for ≥2 years prior to date of study enrollment.\n* Mental incapacity or psychiatric illness preventing informed consent.\n* History of Hepatitis B or C or Hepatitis grade ≥3 are excluded due to the potential for additional hepatotixicity","18 Years","75 Years",{"count":53,"type":20},16,[55],"PHASE2","This phase II trial studies the effect of P140K MGMT hematopoietic stem cells, O6-benzylguanine, temozolomide, and carmustine in treating participants with supratentorial glioblastoma or gliosarcoma who have recently had surgery to remove most or all of the brain tumor (resected). Chemotherapy drugs, such as 6-benzylguanine, temozolomide, and carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing. Placing P140K MGMT, a gene that has been created in the laboratory into bone marrow making the bone more resistant to chemotherapy, allowing intra-patient dose escalation which kills more tumor cells while allowing bone marrow to survive.",[58,59,60,28],"Glioblastoma Multiforme","Glioblastoma Multiforme, Adult","Supratentorial Glioblastoma","2025-11-19",{"date":63,"type":33},"2025-11-21",{"date":65,"type":33},"2023-01-20",{"date":67,"type":20},"2026-12-01",{"name":69,"class":40},"Leland Metheny"]