[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"angioimmunoblastic-t-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:angioimmunoblastic-t-cell-lymphoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,58,115,149],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100597206","phase-1-a-phase-i-trial-anti-cc-chemokine-receptor-4-chimeric-antigen-receptor-t-cells-ccr4-car-t-cells-for-ccr4-expressing-t-cell-malignancies-including-peripheral-t-cell-non-hodgkin-lymphoma-ptcl-and-cutaneous-t-cell-non-hodgkin-lymphoma-ctcl-100597206",false,"NCT07055477","A Phase I Trial Anti-CC Chemokine Receptor 4 Chimeric Antigen Receptor T Cells (CCR4 CAR T Cells) for CCR4 Expressing T-cell Malignancies Including Peripheral T-cell Non-Hodgkin Lymphoma (PTCL) and Cutaneous T-cell Non-Hodgkin Lymphoma (CTCL)","A Phase I Trial of Anti-CC Chemokine Receptor 4 Chimeric Antigen Receptor T Cells (CCR4 CAR T Cells) for CCR4 Expressing T-cell Malignancies Including Peripheral T-cell Non-Hodgkin Lymphoma (PTCL) and Cutaneous T-cell Non-Hodgkin Lymphoma (CTCL)","* INCLUSION CRITERIA:\n* Pathologically (biopsy) confirmed histologic diagnosis of a relapsed\u002Frefractory CCR4+ mature T-cell malignancy from one of the following subtypes: peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), hepatosplenic t-cell lymphoma (HSTCL), monomorphic epithelialtropic intestinal lymphoma (MEITL), enteropathy associated T-cell lymphoma (EATL) or cutaneous T-cell lymphoma (CTCL) including mycosis fungoides and subacute panniculitis-like T-cell Lymphoma, or lymphomatous subtypes of ATL without evidence of CNS involvement or substantial circulating disease confirmed by the Laboratory of Pathology, NCI.\n\n  --CCR4+ is defined as \\>= 10% malignant cells positive for CCR4 by immunohistochemistry. It is preferred to have a fresh biopsy to confirm the CCR4 status. In the event a fresh biopsy cannot be safely performed in the opinion of the treating physician, an archival biopsy sample taken at the time of previous progression can be used.\n* Adequate tissue \\[a formalin fixed tissue block or 15 slides of tumor sample (archival or fresh)\\] from diagnostic biopsy (archival or fresh) must be available.\n\nNOTE: Tissue will be used for assessment of CCR4 expression on malignant cells by immunohistochemistry with any leftover slides or samples to be used for correlative studies. Tumor tissue may be from any previously collected tissue and adequacy is at the discretion of the Principal Investigator. If prior tissue is not available, a screening biopsy will be necessary unless repeat biopsy is deemed unsafe by the treating physician in consultation with the Principal Investigator.\n\n* Participants must have disease that is relapsed or refractory after prior therapy as follows:\n\n  * Participants with ALCL must have failed at least one prior line of Brentuximab-containing therapy.\n  * Due to the generally indolent nature of the disease, participants with Mycosis Fungoides must have exhausted all standard therapies as determined by the enrolling physician and principal investigator to be eligible for this study.\n  * All other participants must have failed at least two lines of prior therapy.\n* Participants must have measurable or evaluable disease at the time of enrollment. For participants with systemic T-cell lymphoma, this is defined by any evidence from CT scan or PET-CT-avid disease based on the Lugano criteria. For participants with Cutaneous T-cell Lymphoma, positive scores based on Modified Severity-Weighted Assessment Tool (mSWAT) criteria are acceptable.\n* Participants must be \\>=18 years of age at the time of signing informed consent.\n* Adequate performance status (PS) as follows: ECOG PS 0-1.\n* Adequate organ function as evidenced by the following laboratory parameters:\n\n  * Absolute neutrophil count (ANC) \\>= 1,000 \u002FmicroL\n  * Platelets \\>= 75,000 \u002F microL\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL (transfusions permitted)\n  * Creatinine Clearance \\>= 60 mL\u002Fmin\u002F1.73m\\^2 per Cockcroft Gault equation; For participants \\\u003C 60 per Cockcroft Gault a direct measurement may be used\n  * Serum total bilirubin \\\u003C= 3 X upper limit of normal (ULN)\n  * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \\\u003C= 3 X ULN\n  * Left ventricular ejection fraction \\> 50% by echocardiogram performed\n  * ECG No clinically significant ECG findings (Arrhythmias or evidence of ischemic heart disease with clinical correlate)\n\nNote: Participants with well-controlled atrial fibrillation are eligible.\n\n--FEV1 and DLCO \\> 60% of predicted (adjustment for Hgb acceptable)\n\n-Individuals of child-bearing potential (IOCBP) must have a negative urine or blood HCG pregnancy test at screening.\n\nNOTE: IOCBP is defined as any person assigned female at birth who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n\n-Individuals of child-bearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) or practice abstinence starting at the time of study entry, for the duration of study therapy, and 12 months after the last dose of combined chemotherapy.\n\nIndividuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and for 4 months after the last dose of combined chemotherapy. We also will recommend these individuals with partners of childbearing potential ask partners to be on highly effective birth control (hormonal, IUD, surgical sterilization)\n\n* Nursing participants must be willing to discontinue nursing through 12 weeks after cell infusion.\n* Potential participants must agree to stay within 1-hour drive of NIH clinical center from date of initial discharge from hospitalization (no earlier than D+15) through initial D+28 follow-up and be willing and able to return for in-person follow-up visits through month 3 of the study.\n* Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with any current or prior CNS involvement by malignancy are excluded from this study. All potential participants will be screened with brain imaging prior to enrollment on study.\n* Participants with \\>1000 atypical cells\u002Fmm\\^3 by peripheral blood flow cytometry at screening.\n* Participants with a history of serologically or biopsy confirmed autoimmune disorders are excluded from this study. As an exception, participants with EATL whose celiac disease is well controlled and who will maintain a strict gluten-free diet are eligible.\n\nParticipants with prior autoimmune thyroiditis who are now on stable thyroid replacement therapy are also eligible.\n\n* HTLV I\u002FII positive participants with a history of HTLV-associated myelopathy\u002Ftropical spastic paraparesis (TSP)\n* Participants who have received prior CD25-directed therapy.\n* Current or prior anti-cancer treatment prior to the first dose of study drug as defined below:\n\n  * Any cytotoxic therapy, immunotherapy, antitumor vaccines or monoclonal antibodies within 2 weeks before the start of lymphodepleting chemotherapy.\n  * High doses of systemic corticosteroids (\\>20 mg prednisone or equivalent) 5 days before apheresis and\u002For 5 days before CAR T cell infusion.\n  * Participants who have not reached D+100 following auto-SCT or who have any unresolved Auto-SCT related complications (e.g. pneumonitis).\n  * Participants who have undergone prior allogeneic stem cell at any time.\n* Participants taking any investigational agents for any disease\u002F condition.\n* Seropositive for human immunodeficiency virus (HIV).\n* Active bacterial infections or active viral infections (CMV, syphilis)\n* Uncontrolled EBV infection Note: EBV positive test is allowed due to frequent association of active EBV with mature T-cell malignancies, which frequently resolve with improved control of the malignancy. EBV positive participants may be treated with rituximab or biosimilar prior to lymphodepleting chemotherapy at investigator s discretion.\n* Active hepatitis C infection.\n\nNOTE: Participants seropositive for hepatitis C virus (HCV) infection must have been treated and cured as defined by undetectable HCV viral load.\n\n-Active hepatitis B infection.\n\nNOTE: Participants that are positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) must have a negative hepatitis B virus polymerase chain reaction (HBV PCR) result \\\u003C100 IU\u002FmL at screening. Those who are HBV PCR positive are excluded. Those hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with a negative PCR for hepatitis B will be treated with antivirals designed to prevent hepatitis B reactivation (e.g., entecavir) and have monitoring for hepatitis B reactivation with PCR.\n\n* Participants with current cardiac atrial or cardiac ventricular lymphoma involvement.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within 12 months of enrollment.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computer tomography (CT) scan at screening.\n\nNOTE: History of radiation pneumonitis in the radiation field (fibrosis) is allowed.\n\n* History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n* Deep vein thrombosis or pulmonary embolism requiring ongoing systemic anticoagulation\n* History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study\n* Participants with second malignancies in addition to their T-cell malignancy are not eligible if the second malignancy has required treatment (including maintenance therapy) within the past 3 years or is not in complete remission. There are two exceptions to this criterion: successfully treated non-metastatic basal cell or squamous cell skin carcinoma.\n* Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the participant.","ALL","18 Years","120 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\nChemokine receptor 4 (CCR4) is a protein that is found on the surface of certain T-cell lymphoma cells and is common in mature T-cell cancers. White blood cells can be changed with molecules called anti-CCR4 to express a chimeric antigen receptors (CAR), which is a molecule that directs a white blood cell to attack other cells. The CAR in this study attacks the CCR4 protein found on your T-cell lymphoma. This type if therapy is called gene therapy. Gene therapy involves a person s own white blood cells modified to target cancer cells. More research is needed to find out if gene therapy can treat T-cell cancers and do it safely.\n\nObjective:\n\nTo test safety of giving people with certain mature T-cell lymphomas their own white blood cells modified with anti-CCR-4 CAR.\n\nEligibility:\n\nPeople aged 18 and older with certain mature T-cell lymphomas that have not responded to or have come back after treatment. They must have a T-cell lymphoma that has CCR4 on the surface of the cancer cells.\n\nDesign:\n\nParticipants will be screened. They will have a medical history and physical exam. Tests of blood, urine, and heart and lung function will be done.\n\nParticipants will have tests:\n\nComputed tomography (CT), positron emission tomography (PET), and magnetic resonance imaging scans: They will lie on a table that slides into a donut-shaped machine or a tube. Pictures of the inside of the body will be taken. Before the PET scan, they will get an injection of radioactive fluid in a vein in the arm. Before the MRI, they may get a contrast dye injected through a vein (IV) in the arm.\n\nA biopsy of the tumor may be taken. A bone marrow sample may be taken from the hip: The area will be numbed and a large needle inserted through the skin.\n\nLeukapheresis will be done to obtain T-cells that will be genetically modified to express anti-CCR4 CARs on T-cells: Blood is drawn through an IV in one arm, circulated through a machine, and then returned through an IV in the other arm.\n\nChemotherapy drugs will be given in an IV to prepare the body to accept the modified CAR T cells.\n\nThe modified cells will be given in an IV.\n\nParticipants will be followed for 15 years: This will require blood tests over the first 1-2 years followed by yearly visits and possibly telehealth updates.",[27,28,29,30,31,32,33,34,35,36],"Relapsed and\u002For Refractory Mature T Cell Malignancy","Peripheral T-Cell Lymphoma","Angioimmunoblastic T-cell Lymphoma","Anaplastic Large Cell Lymphoma","Hepatosplenic T-cell Lymphoma","Monomorphic Epithelialtropic Intestinal Lymphoma","Enteropathy Associated T-cell Lymphoma","Cutaneous T-Cell Lymphoma","Mycosis Fungoides","Subacute Panniculitis-like T-cell Lymphoma",[38,39,40,41,42,43,44],"CCR4","CAR T","Chemokine Receptor 4","Chimeric Antigen Receptor","Gene Therapy","Cell Therapy","Immunotherapy","RECRUITING","2026-06-24",{"date":48,"type":49},"2026-06-25","ACTUAL",{"date":51,"type":49},"2025-09-29",{"date":53,"type":21},"2044-06-01",{"name":55,"class":56},"National Cancer Institute (NCI)","NIH",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":65,"targetDuration":67,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":99,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100514411","a-registry-for-people-with-t-cell-lymphoma-100514411","NCT05978141","A Registry for People With T-cell Lymphoma","The T-cell Lymphoma Master Repository (TCLMR): A Prospective Databank of Patients With T-cell Lymphoma With Clinical Annotation and Matched Tumor Specimens","Inclusion Criteria:\n\n* Written informed consent\n* Adequate fresh or archival tumor biopsy or intent to obtain fresh tumor biopsy.\n* Pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma meeting one of the following diagnostic criterion (based on WHO classification and NCCN guidelines):\n\n  * T-cell prolymphocytic leukemia\n  * T-cell large granular lymphocytic leukemia\n  * Chronic lymphoproliferative disorder of NK cells\n  * Aggressive NK-cell leukemia\n  * Systemic Epstein-Barr virus (EBV)-positive T-cell lymphoma of childhood\n  * Chronic active EBV infection of T- and NK-cell type, systemic form\n  * Hydroa vacciniforme-like lymphoproliferative disorder\n  * Adult T-cell leukemia\u002Flymphoma\n  * Extranodal NK\u002FT-cell lymphoma, nasal type\n  * Enteropathy-associated T-cell lymphoma\n  * Monomorphic epitheliotropic intestinal T-cell lymphoma\n  * Intestinal T-cell lymphoma, not otherwise specified (NOS)\n  * Indolent T-cell lymphoproliferative disorder of the gastrointestinal tract\n  * Hepatosplenic T-cell lymphoma\n  * Subcutaneous panniculitis-like T-cell lymphoma\n  * Mycosis fungoides (limited to those with ≥ stage IB disease and those receiving active therapy)\n  * Sézary syndrome\n  * Primary cutaneous anaplastic large cell lymphoma (receiving systemic therapy)\n  * Primary cutaneous Gamma-Delta T-cell lymphoma\n  * Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma\n  * Primary cutaneous acral CD8+ T-cell lymphoma (receiving systemic therapy)\n  * Peripheral T-cell lymphoma, not otherwise specified\n  * Angioimmunoblastic T-cell lymphoma\n  * Follicular T-cell lymphoma\n  * Nodal peripheral T-cell lymphoma with TFH phenotype\n  * Anaplastic large cell lymphoma, ALK-positive\n  * Anaplastic large cell lymphoma, ALK-negative\n  * Breast-implant associated anaplastic large cell lymphoma.\n* NOTE: Patients with diagnoses of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma must be receiving systemic therapy.\n\nExclusion Criteria:\n\n* Patients with of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma not receiving systemic therapy.\n* Inability to collect prospective data, measure response, or perform adequate follow-up assessments in the clinical judgment of the treating physician. NOTE: Repository participation does not exclude participation in clinical trials, nor does existing clinical trial participation exclude enrollment in the study herein outlined.",{"count":66,"type":21},1000,"10 Years","OBSERVATIONAL","The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma. Researchers will use the information from this database to learn more about how to improve outcomes for people with T-cell lymphoma.",[71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,31,87,35,88,89,90,91,92,93,29,94,95,96,97,98],"T-cell Lymphoma","NK-Cell Lymphoma","T-cell Prolymphocytic Leukemia","T-cell Large Granular Lymphocytic Leukemia","Chronic Lymphoproliferative Disorder of NK Cells","Aggressive NK-cell Leukemia","Systemic Epstein-Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood (Disorder)","Systemic Epstein Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood","Chronic Active EBV Infection of T-and NK-Cell Type, Systemic Form","Hydroa Vacciniforme-Like Lymphoproliferative Disorder","Adult T-cell Leukemia\u002FLymphoma","Extranodal NK\u002FT-cell Lymphoma, Nasal Type","Enteropathy-associated T-cell Lymphoma","Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma","Intestinal T-Cell Lymphoma, Not Otherwise Specified","Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract","Subcutaneous Panniculitis-Like T-Cell Lymphoma","Sezary Syndrome","Primary Cutaneous Anaplastic Large Cell Lymphoma","Primary Cutaneous T-cell Lymphoma","Primary Cutaneous CD8-Positive Aggressive Epidermotropic T-Cell Lymphoma","Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma","Peripheral T-Cell Lymphoma, Not Otherwise Specified","Follicular T-Cell Lymphoma","Nodal Peripheral T-Cell Lymphoma With TFH Phenotype","Anaplastic Large Cell Lymphoma, ALK-Positive","Anaplastic Large Cell Lymphoma, ALK-negative","Breast Implant-Associated Anaplastic Large Cell Lymphoma",[100,101,102,103,104],"23-190","T-cell lymphoma","Memorial Sloan Kettering Cancer Center","T-cell Lymphoma Master Repository","TCLMR","2026-05-18",{"date":107,"type":49},"2026-05-20",{"date":109,"type":49},"2023-07-27",{"date":111,"type":21},"2030-07-27",{"name":102,"class":113},"OTHER",26,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":126,"conditions":127,"keywords":131,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":148},"100559201","phase-3-soquelitinib-vs-standard-of-care-in-participants-with-relapsedrefractory-peripheral-t-cell-lymphoma-not-otherwise-specified-follicular-helper-t-cell-lymphomas-or-systemic-anaplastic-large-cell-lymphoma-100559201","NCT06561048","Soquelitinib vs Standard of Care in Participants With Relapsed\u002FRefractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma","A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed\u002FRefractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma","Inclusion Criteria:\n\n1. Adult participants ≥18 years of age on the day of signing the informed consent form.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.\n4. Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies.\n5. Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the site radiologist.\n6. Life expectancy \\>12 weeks.\n7. Adequate organ function as determined by:\n\n   * Absolute neutrophil count ≥ 1.0×10\\^9\u002FL (1000\u002Fmm3) (without receiving granulocyte-colony stimulating factor)\n   * Platelet count ≥ 100×10\\^9\u002FL (without transfusion)\n   * Hemoglobin ≥ 9.0 g\u002FdL, without packed red blood cell transfusion within the last 1 week of starting study drug\n   * Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × upper limit of normal (ULN), unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants\n   * Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL\u002Fminute\n   * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN. For participants with Gilbert's disease: ≤ 3.0 mg\u002FdL or discussion with the Medical Monitor\n   * Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)\n   * Serum albumin \\> 2.5 g\u002FdL\n   * Serum calcium \\\u003C 12 mg\u002FdL or corrected serum calcium \\\u003C ULN\n8. Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline except for the following:\n\n   * Grade ≤ 2 neuropathy\n   * Alopecia and non-acute toxicities\n   * If major received major surgery, then must have recovered adequately per the investigator from the toxicity and\u002For complications from the intervention prior to starting study treatment\n9. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 120 days after the last dose of study drug for participants who receive soquelitinib, or 6 months after the last dose for participants who receive either belinostat or pralatrexate.\n10. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 120 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Participants who have T-cell lymphoma with active central nervous system involvement.\n2. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.\n3. History of primary immunodeficiency or sold organ transplantation.\n4. History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.\n5. Any active infection requiring IV therapy.\n6. History of invasive prior malignancy that required systemic therapy within last 3 years.\n7. Any condition that confounds the ability to interpret data from the study.\n8. Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \\[HBsAg\\]) or positive test for hepatitis C antibody.\n9. Monoclonal antibody therapy for cancer, radiotherapy, or chemotherapy within 3 weeks and targeted therapy within 2 weeks prior to the first dose of study treatment.\n10. Prior administration of an ITK inhibitor.\n11. Participants who need immediate cytoreductive therapy.\n12. Participants requiring the concomitant use of strong inhibitors or inducers of CYP3A or who have received these within 5 half-lives or 14 days prior to the start of study treatment.\n13. History of allogeneic hematopoietic stem cell transplantation.\n14. Candidate for hematopoietic stem cell transplantation at screening.\n15. History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.\n16. Concurrent enrollment in another clinical study\n17. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study, starting with the screening visit through 6 months after the last dose of study treatment.\n18. Participants who cannot ingest medications orally or who have malabsorption.",{"count":123,"type":21},150,[125],"PHASE3","A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed\u002Frefractory (R\u002FR) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).",[93,29,94,95,128,129,130],"Systemic Anaplastic Large Cell Lymphoma","Lymphoma, T-Cell, Peripheral","Lymphoma, T-Cell",[132,133,134,135,136,137],"Peripheral T-Cell Lymphoma, Not Otherwise Specified (PTCL-NOS)","Follicular Helper T-Cell Lymphoma (FHTCL)","Angioimmunoblastic T-cell Lymphoma (AITL)","Follicular T-Cell Lymphoma (FTCL)","Nodal Peripheral T-Cell Lymphoma with T Follicular Helper Phenotype (PTCL-Tfh)","Systemic Anaplastic Large Cell Lymphoma (sALCL)","2026-04-02",{"date":140,"type":49},"2026-04-08",{"date":142,"type":49},"2024-10-02",{"date":144,"type":21},"2028-12",{"name":146,"class":147},"Corvus Pharmaceuticals, Inc.","INDUSTRY",34,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":167,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100380473","phase-1-phase-1-trial-of-st-001-nanofenretinide-in-relapsedrefractory-t-cell-non-hodgkin-lymphoma-100380473","NCT04234048","Phase 1 Trial of ST-001 nanoFenretinide in Relapsed\u002FRefractory T-cell Non-Hodgkin Lymphoma","A Phase 1a\u002F1b Trial in Relapsed\u002FRefractory T-cell Non-Hodgkin Lymphoma to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg\u002FmL) for Intravenous Infusion","Inclusion Criteria:\n\n* All patients must have histologically or cytologically confirmed diagnosis of the following specific types of T-cell lymphomas (TCL):\n\n  1. Cutaneous T-cell lymphoma (CTCL): mycosis fungoides (MF), Sézary Syndrome (SS), or primary cutaneous CD30+ anaplastic large cell lymphoma (cALCL).\n  2. Nodal TCL: Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma (AITL), or follicular T-cell lymphoma (FTCL) as defined in the 2016 revision of the WHO classification of lymphoid malignancies\\[98\\] (Appendix A).\n* For standard phase 1a and expanded cohort (1b): Patients must all have at least one measurable disease site using criteria provided in section 11.\n* Relapsed or refractory (R\u002FR) disease, after at least 1 prior treatment regimen as per disease staging (including but not limited to oral bexarotene, interferon, any oral or IV HDAC inhibitor, any topical, oral or IV chemotherapy drugs, radiotherapy, retinoids, topical steroids, systemic steroids, phototherapy, immunomodulators, Biologics and others based on PI discretion. Refer to section 2.1 of the protocol for more details).\n* Refractory disease is defined as lack of objective response (i.e., partial or complete response) to most recent therapy.\n* Relapsed disease is defined as recurrent disease after prior therapy that does not qualify as refractory disease.\n* Other systemic treatments not specified may be allowed based on PI judgement in consultation with the Sponsor.\n* For primary cutaneous lymphomas, stage IB, II, III and IV according to the TNMB system (Appendix C) are eligible. For primary nodal lymphomas, patients with stages II-IV according to the Ann Arbor staging system are eligible.\n* Minimum of 4 weeks must have elapsed since last systemic treatment or radiation therapy treatment (or 6 weeks for any nitrosourea-containing regimens), and patients must have recovered from all toxicity of last treatment. If the PI assesses that it is in the best interest of the patient to have a shorter washout period, they may submit a written request to the sponsor and can enroll the patient after written approval has been received.\n* Age ≥18 years. Both genders are included. However, women of childbearing potential must have a negative B-HCG serum pregnancy test (see Section 10 Study Calendar, Pre-Study, footnote b) and agree to use effective contraceptive methods for the duration of the study. A urine pregnancy test is required just prior to the first dosing session of every treatment cycle.\n* ECOG performance status 0-1 (Karnofsky ≥60%, see Appendix B).\n* Life expectancy greater than 6 months.\n* Patients must have normal organ and marrow function as defined below:\n* Leukocytes ≥ 3,000\u002FμL\n* Absolute neutrophil count ≥ 1,500\u002FμL\n* Platelets ≥ 100,000\u002FμL\n* Total bilirubin within normal institutional limits. Patients with total bilirubin ≤ 1.5 X upper limit of normal are eligible\n* AST (SGOT) and ALT (SGPT) within institutional upper limit of normal\n* Creatinine clearance ≥60 mL\u002Fmin\u002F1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation\n\nOr if the patient were to have bone marrow involved NHL, the hematological requirements should be as listed below:\n\n* Absolute neutrophil count ≥ 500\u002FμL\n* Platelets ≥ 50,000\u002FμL\n* Triglyceride blood level (fasting) \\\u003C300mg\u002FdL at time of enrollment (normal: \\\u003C150mg\u002FdL; borderline high = 150-199mg\u002FdL; high = 200-499mg\u002FdL; very high = 500mg\u002FdL or higher).\n* ST-001 is an experimental drug and the risks to the unborn or nursing child are unknown. Pregnant or breastfeeding women cannot take part in this study. Women of childbearing age are required to have a blood and\u002For urine pregnancy test before beginning the investigational study treatment. If you are sexually active, it is important that you not become pregnant or father a child because this medication may be harmful to your unborn child. Patients must discuss pregnancy plans with their doctor before enrolling in this study and agree that they will take the appropriate precautions not to become pregnant while enrolled in the study.\n\nIf there is any chance that patient can get pregnant, patient must either agree to not have vaginal intercourse or you must use two (2) types of birth control (hormonal, barrier method of birth control, abstinence) at the same time. These birth control methods must be used from the time of enrollment, all during investigational study treatment including during temporary breaks from therapy, and for at least 4 months after the last dose of ST-001.\n\n• Informed consent of the patient or a legal authorized representative (LAR) must be obtained prior to any study related procedures.\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Patients who are receiving any other investigational agents.\n* Patients with known or history of central nervous system (CNS) disease are excluded from this clinical trial because of their poor prognosis and because of concerns regarding toxicity attribution.\n* History of allergic reactions or sensitivity to retinoids or to any excipients of ST-001.\n* Concomitant drug administration.\n\nPatients who require concurrent treatment with drugs that are strong CYP3A inducers are excluded from the trial. Patients who have been treated previously with strong CYP3A inducers may enroll in the trial and receive their first dose of ST-001 only after four weeks have elapsed since the last dose of the CYP3A inducer. Strong inducers of human CYP3A include barbiturates, bosentan, carbamazepine, efavirenz, enzalutamide, etravirine, systemic glucocorticoids, mitotane, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, troglitazone as well as the OTC herbal product St John's Wort (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdevelopmentapprovalprocess\u002Fdevelopmentresources\u002Fdruginteractionslabeling\u002Fucm093664.htm#table2-3; http:\u002F\u002Fwww.mayomedicallaboratories.com\u002Fit-mmfiles\u002FCytochrome\\_P450\\_3A4\\_and\\_3A5\\_Known\\_Drug\\_Interaction\\_Chart.pdf; http:\u002F\u002Foncologypro.esmo.org\u002Fcontent\u002Fdownload\u002F66542\u002F1203090\u002Ffile\u002FCYP3A-inhibitors-inducers-DDI.pdf)\n\nPatients who require concurrent treatment with drugs that are strong to moderate CYP3A inhibitors are excluded from the trial, and patients who have been treated previously with strong CYP3A inhibitors may enroll in the trial and receive their first dose of ST-001 only after four weeks have elapsed since the last dose of the CYP3A inhibitor. This group of inhibitors includes certain antivirals (boceprevir, danoprevir, paritaprevir; elvitegravir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir, tipranavir; ombitasvir, dasabuvir), macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin, troleandomycin) and ciprofloxacin, antifungals (e.g., clotrimazole, fluconazole, ketoconazole, itraconazole, nefazodone, posaconazole, voriconazole), aprepitant, cimetidine, cobicistat, conivaptan, crizotinib, cyclosporine, diltiazem, dronedarone, idelalisib, luvoxamine, imatinib, tofisopam, suboxone and verapamil as well as dietary grapefruit juice and grapefruit (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdevelopmentapprovalprocess\u002Fdevelopmentresources\u002Fdruginteractionslabeling\u002Fucm093664.htm#table2-3; http:\u002F\u002Fwww.mayomedicallaboratories.com\u002Fit-mmfiles\u002FCytochrome\\_P450\\_3A4\\_and\\_3A5\\_Known\\_Drug\\_Interaction\\_Chart.pdf; http:\u002F\u002Foncologypro.esmo.org\u002Fcontent\u002Fdownload\u002F66542\u002F1203090\u002Ffile\u002FCYP3A-inhibitors-inducers-DDI.pdf)\n\nIf patients being treated with ST-001 require the use of drugs that are either strong inducers of CYP3A or strong to moderate inhibitors of CYP3A to treat a medical condition, all treatment with ST-001 should be discontinued immediately and no further treatment with ST-001 will be allowed.\n\nUse of acetaminophen, cephalosporins and other known hepatotoxic agents is allowed with caution and close monitoring, due to known or potential interaction with ST-001 and potential increased risk of hepatotoxicity\\[52\\]. Patients who require replacement therapy with oral steroids should be allowed to continue the treatment if treatment with stable dose has been initiated more than 2 weeks prior to beginning ST-001 infusion. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated list such as http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002F. Medical reference texts such as the Physicians' Desk Reference may also provide this information.\n\nAs part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Physician investigators should consult the websites listed above for the most current information regarding drug interactions via CYP3A isozymes.\n\nUse of vitamin A supplements is prohibited. Standard multivitamin doses are allowed.\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY heart classification III\u002FIV), unstable angina pectoris, cardiac arrhythmia, QTc interval \\>450 milliseconds on baseline triplicate ECG, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because ST-001is a retinoid agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ST-001, breastfeeding should be discontinued if the mother is treated with ST-001.\n* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ST-001. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n* Patients with any active hepatitis infections.\n* Presence of nyctalopia (night blindness), or hemeralopia (defective vision in a bright light, 'day blindness') at enrollment, or any other retinal, ophthalmological condition (eg: retinitis pigmentosa, choroidoretinitis and xerophthalmia), and glaucoma.\n* Patients who have received prior fenretinide systemic therapy\n* Patients with T-cell lymphoma types other than those specified in section 3.1.1 are not eligible even if they have cutaneous dissemination. Similarly, patients with any type of natural killer (NK)- or B-cell lymphoma are not eligible regardless of sites of involvement by disease.",{"count":157,"type":21},46,[24],"This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).",[71,161,162,163,90,164,165,94,29,166,35],"Cutaneous\u002FPeripheral T-Cell Lymphoma","Peripheral T-cell Lymphoma","Peripheral T-Cell Lymphoma, Not Classified","Cutaneous T-Cell Lymphoma, Unspecified","Cutaneous T-cell Lymphoma","Sézary's Disease",[168,169,170,171,172,173,174],"Lymphoma","CTCL","Sézary syndrome","mycosis fungoides","PTCL","AITL","cALCL","2025-09-16",{"date":177,"type":49},"2025-09-22",{"date":179,"type":49},"2023-12-18",{"date":181,"type":21},"2027-05-01",{"name":183,"class":147},"SciTech Development, Inc.",10]