[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615788":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":52,"responsibleParty":77,"collaborators":80,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":27,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":109,"overallStatus":114,"whyStopped":27,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm A - Lymphoma and Solid Tumors","EXPERIMENTAL","CD70.CAR: Three dose levels, and a possible dose level -1 in case of unexpected toxicity at dose level 1, will be evaluated for patients with lymphoma and solid tumors. Each patient will receive one T cell infusion. Dose levels will be defined based on number of transduced T cells measured by flow cytometry.\n\nThe first three patients treated on the study will be adults 18 years of age or older, which can be treated in each cohort.",[13,14,15,16],"Biological: Dose Level -1","Biological: Dose Level 1 (starting dose level)","Biological: Dose Level 2","Biological: Dose Level 3",{"label":18,"type":10,"description":19,"interventionNames":20},"Treatment Arm B - Myeloma","CD70.CAR: Three dose levels, and a possible dose level -1 in case of unexpected toxicity at dose level 1, will be evaluated for patients with myeloma. Each patient will receive one T cell infusion. Dose levels will be defined based on number of transduced T cells measured by flow cytometry.\n\nThe first three patients treated on the study will be adults 18 years of age or older, which can be treated in each cohort.",[13,14,15,16],[22,28,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","Dose Level -1","Dose Level -1: 3 x 10\\^5 cells\u002Fkg",[9,18],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Dose Level 1 (starting dose level)","Dose Level 1 (starting dose level): 1 x 10\\^6 cells\u002Fkg",[9,18],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Dose Level 2","Dose Level 2: 3 x 10\\^6 cells\u002Fkg",[9,18],{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Dose Level 3","Dose Level 3: 1 x 10\\^7 cells\u002Fkg",[9,18],[41],{"name":42,"affiliation":5,"role":43},"Bilal Omer, MD","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":27,"email":48},"CONTACT","832-826-0860","baomer@texaschildrens.org",{"name":50,"role":46,"phone":27,"phoneExt":27,"email":51},"Brandon Garner","bjgarner@texaschildrens.org",[53,69],{"facility":54,"status":27,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Texas Children's Hospital","Houston","Texas","77030","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-95.36327,29.76328,{"lat":64,"lon":63},[67,68],{"name":42,"role":46,"phone":47,"phoneExt":27,"email":48},{"name":50,"role":46,"phone":27,"phoneExt":27,"email":51},{"facility":70,"status":27,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"The Methodist Hospital",{"type":61,"coordinates":72},[63,64],{"lat":64,"lon":63},[75,76],{"name":42,"role":46,"phone":47,"phoneExt":27,"email":48},{"name":50,"role":46,"phone":27,"phoneExt":27,"email":51},{"type":43,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Bilal Omer","Associate Professor",[81,83],{"name":82,"class":6},"Center for Cell and Gene Therapy, Baylor College of Medicine",{"name":84,"class":6},"The Methodist Hospital Research Institute","100615788","phase-1-cd70car-for-cd70-lymphoma-myeloma-and-solid-tumors-100615788",false,"NCT07297160","CD70.CAR for CD70+ Lymphoma, Myeloma and Solid Tumors","Chimeric Antigen Receptor Treatment Targeting Lymphoma, Myeloma and Solid Tumors That Express CD70 (SEventY) CALySSEY","CALySSEY","PROCUREMENT INCLUSION CRITERIA:\n\n• Diagnosis of relapsed\u002Frefractory T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin Lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell lymphoma (lymphoma or chronic subtypes, Extranodal NK\u002FT cell lymphoma, Mycosis fungoides (excluding Sezary Syndrome Stage IIB or higher) or multiply relapsed Hodgkin Lymphoma\n\nOR\n\nPatients with relapsed\u002Frefractory Renal Cell Carcinoma (RCC) OR sarcomas (for sarcoma only patients age 25 or younger are eligible)\n\nOR\n\nPatients with relapsed or refractory multiple myeloma (MM) that have failed or are ineligible for the 3 main classes of MM therapy (\"triple class refractory\")\n\n(3 classes: 1. Immunomodulatory drugs, 2. proteosome inhibitors and 3. Anti-CD38 monoclonal antibodies).\n\n* CD70 positive tumor with at least 26% CD70+ tumor cells by immunohistochemistry (staining can be pending at time of procurement)\n* Age ≤75 years (except for sarcoma: only patients age ≤25 are eligible) NOTE: The first three (3) patients treated on the study will be adults (≥18 years of age)\n* Hemoglobin ≥ 7.0 g\u002FdL (can be transfused)\n* If apheresis required to collect blood, PT and aPTT \\\u003C1.5x ULN; Serum Creatinine \\\u003C 2 x ULN; AST \\\u003C 5 x ULN.\n\nPROCUREMENT EXCLUSION CRITERIA:\n\n* Active infection (bacterial, fungal or viral) requiring ongoing treatment without improvement.\n* 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.\n* 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\n* Ongoing treatment with immune suppression for prophylaxis\u002Ftreatment of GVHD including high dose steroids (e.g., prednisone \\> 0.5 mg\u002Fkg\u002Fday).\n\nTREATMENT INCLUSION CRITERIA:\n\n• Diagnosis of relapsed\u002Frefractory T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin Lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell lymphoma (lymphoma or chronic subtypes), , Extranodal NK\u002FT cell lymphoma, Mycosis fungoides (excluding Sezary Syndrome Stage IIB or higher) or multiply relapsed Hodgkin Lymphoma\n\nOR\n\nPatients with relapsed\u002Frefractory Renal Cell Carcinoma (RCC) or sarcomas (for sarcoma only patients age 25 or younger are eligible)\n\nOR\n\nPatients with relapsed or refractory multiple myeloma (MM) that have failed or are ineligible for the 3 main classes of MM therapy (\"triple class refractory\") and also failed or ineligible for anti-BCMA therapies.\n\n(3 classes: 1. Immunomodulatory drugs, 2. proteosome inhibitors and 3. Anti-CD38 monoclonal antibodies).\n\n* CD70 positive tumor with at least 26% CD70+ tumor cells by immunohistochemistry (tissue)\n* 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\n* Age ≤75 years. (except for sarcoma: only patients age ≤25 are eligible) NOTE: The first three (3) patients treated on the study will be adults (≥18 years of age).\n* Hemoglobin ≥ 7.0 g\u002FdL (can be transfused)\n* Total bilirubin \\\u003C 3 times the upper limit of normal\n* AST\u002FALT \\\u003C 5 times the upper limit of normal\n* Creatinine \\\u003C 2 times the upper limit of normal\n* Pulse oximetry of \\> 90% on room air\n* Karnofsky or Lansky score of ≥60%\n* 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.\n* Informed Consent Obtained.\n\nTREATMENT EXCLUSION CRITERIA:\n\n* Received investigational anti-cancer agents \\\u003C 28 days or 5 half-lives, whichever is shorter\n* Received any tumor vaccines within the previous 6 weeks\n* Pregnant or lactating\n* Uncontrolled infection with HIV, or HTLV. Patients with HIV are eligible if viral load is undetectable on therapy and CD4 count is \\>350 mm3.\n* Clinically significant bacterial, fungal, or viral infection requiring ongoing therapy without improvement.\n* Cardiac abnormalities: Cardiac echocardiography with LVEF\\\u003C50%; Cardiac dysfunction NYHA III or IV; Clinically significant pericardial effusion. Confirmation of absence of these conditions must be obtained within 6 months of treatment.\n* Use of serotherapy with Campath or Anti-Thymocyte Globulin (ATG) within the last 28 days\n* Use of Donor Lymphocyte Infusion (DLI) or other cellular therapy product within 28 days.\n* Acute GVHD ≥ Grade 2 or moderate to severe (formerly extensive) chronic GVHD.\n* High dose steroids \\>1 mg\u002Fkg within the preceding 5 days or currently receiving \\>0.5 mg\u002Fkg\u002Fday prednisone equivalent.\n* Bulky CNS or mediastinal disease that significantly increases potential risks (e.g. airway obstruction, TIAN) in the estimation of a principal investigator.","ALL","0 Years","75 Years",{"count":97,"type":98},88,"ESTIMATED","INTERVENTIONAL",[101],"PHASE1","This study is for patients who have a type of cancer that expresses the protein CD70, which includes lymphoma (lymph gland cancer), myeloma and solid tumors including some sarcomas and kidney cancers, and the cancer 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, patients 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 tumor cells in the body.\n\nThis 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\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 tumor cells when it binds to CD70. CD70 binders have been used to treat people with different types of cancers. 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 binder 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 that stimulate T cells. The anti-CD70 (CD27) protein is unique because it can bind to CD70 on tumor 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 tumor 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 lymphoma (lymph gland cancer), myeloma and certain solid tumors including some sarcomas and kidney cancers.",[104,105,106,107,108],"Lymphoma","Myeloma","Solid Tumors","Sarcoma","Kidney Cancer",[104,105,106,110,111,112,113],"T cell","CD70.CAR T-cells","Blood Cancer","Lymph Gland Cancer","NOT_YET_RECRUITING","2026-03-03",{"date":117,"type":118},"2026-03-04","ACTUAL",{"date":120,"type":98},"2026-06",{"date":122,"type":98},"2044-12",{"name":5,"class":6},2]