[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TScan Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":143},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,61,81,115],{"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":28,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100053848","phase-1-a-phase-13-study-of-t-cell-receptor-engineered-donor-t-cells-in-subjects-undergoing-allogeneic-peripheral-blood-stem-cell-transplantation-alloha-2-100053848",false,"NCT05473910","A Phase 1\u002F3 Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)","A Phase 1\u002F3 Study Evaluating the Efficacy and Safety of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)","Inclusion Criteria:\n\n* Male or female aged ≥ 18 years at the time of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG)-PS ≤ 2 at the time of the screening visit.\n* Contraceptive use by male and female participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Male Participants:\n* A male participant must agree to use a highly effective contraceptive as detailed in Appendix 4 of this protocol during the intervention period and for at least 12 months after the last dose of study intervention and refrain from donating sperm during this period.\n* Female Participants:\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n* Not a woman of childbearing potential (WOCBP) OR\n* A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 12 months after the last dose of study intervention.\n* Preparing to undergo allogeneic HCT for either of the following:\n* AML, MDS, ALL\n* Participants in the treatment arms must express HLA-A\\*0201. Participants in the control arm may express any HLA type.\n* Having the HA1+\u002F- or HA-1+\u002F+ (HA-1 positive) genotype to be eligible for TSC-100 treatment.\n* Having the HA2+\u002F- HA-2+\u002F+ (HA-2 positive) genotype to be eligible for TSC-101 treatment.\n* Having a haploidentical donor, MMUD, or MUD for HCT who is adequately HLA-matched by institutional standards and meets the donor inclusion criteria.\n\nConsidered to be clinically indicated for haploidentical donor, MMUD, or MUD transplantation at the discretion of the treating investigator.\n\nConsidered to be clinically indicated for RIC at the discretion of the treating investigator.\n\nConsidered to be clinically indicated for peripheral blood stem cell transplantation at the discretion of the treating investigator.\n\nOrgan function parameters for transplant eligibility are met per institutional standards.\n\nCapable of giving signed informed consent - which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nParticipants must provide consent for mandatory study procedures including bone marrow biopsy and blood sampling for research analyses in the ICF.\n\nParticipants must agree to participate in long-term follow-up for up to 15 years post initial product treatment if they are enrolled in the study and receive the investigational Tcell infusion.\n\nDonor Inclusion Criteria :\n\nMale or female aged ≥ 18 years at the time of signing the informed consent. Able to undergo peripheral blood stem cell (PBSC) collection and up to 2 rounds of leukapheresis (for TSC-100 or TSC101 manufacturing for treatment arms only, and f for stem cell collection for both treatment arms and the control arm).\n\nDonors matched to TSC-100 participants should be HA-1-\u002F- (negative) and\u002For negative for all HLA-A\\*02 alleles Donors matched to TSC-101 participants should be negative for all HLA-A\\*02 alleles Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\nMedical or psychological conditions that would make the participant an unsuitable candidate for cell therapy including another concurrent uncontrolled malignancy or active CNS disease.\n\nThe presence of organ toxicities will not necessarily exclude participants from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA1\u002FHA2 TCRT cells may be required at the discretion of the treating investigator Participants with levels of donor-specific HLA antibodies that are considered by the treating investigator to be high enough to warrant desensitization protocols and who have no alternate donors.\n\nParticipants who meet inclusion criteria for TSC-101 but who are also positive for HLAA\\*02:07.\n\nParticipants with evidence of clinically significant infection or uncontrolled viral r reactivation of cytomegalovirus (CMV), Epstein-Barr virus (EBV), Adenovirus, BK virus (BKV), or human herpesvirus 6 (HHV-6).\n\nParticipants with active cardiac disease, defined as:\n\nUncontrolled or symptomatic angina within the past 3 months. History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes). Atrial fibrillation with controlled ventricular response on treatment is not an exclusion.\n\nMyocardial infarction \\\u003C 3 months from study entry. Uncontrolled or symptomatic congestive heart failure. Prior allogeneic HCT. Participants who have a history of hypersensitivity to murine proteins. Enrollment on a concomitant trial with a novel investigational agent. Use of anti-thymocyte globulin, alemtuzumab, or other in vivo T-cell depleting agents from Day -14 through end of study.\n\nDonor Exclusion Criteria :\n\nDonors for TSC-100 positive for any HLA-A\\*02 allele would be excluded unless they are HA-1 negative. If donors with any HLA-A\\*02 allele are considered for patients eligible for TSC-100, the donor would undergo HA-1 testing to ensure that the donor is HA-1 negative (40% probability).\n\nDonors for TSC-101 positive for any HLA-A\\*02 allele are excluded regardless of HA- 2 status.\n\nDonors who test positive for any of the following: HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection, syphilis, West Nile virus through central lab testing. Donors who screen positive for risk of CreutzfeldtJakob disease or Zika virus infection using donor history questionnaires will also be excluded. Donors with evidence of past CMV or EBV infections will be allowed.\n\nRelated donor residing outside of the United States of America (USA). If the donor screening, testing and leukapheresis can be performed at the same site where the participant is being treated, the donor is considered eligible.","ALL","18 Years",{"count":19,"type":20},310,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating dose regimen of up to 2 doses of TSC-100 and TSC-101 in patients with AML, MDS, or ALL following HCT from a haploidentical donor, MMUD, or MUD",[26,27],"AML","MDS",[29,30,26,27,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,16,47],"HA-2","TSC-101","Adoptive Cell Therapy","T-cell receptor","T lymphocyte","TCR-engineered T cells","bone marrow transplant","haploidentical","allogeneic stem cell transplant","BMT","RIC","HSCT","Hematopoietic stem cell transplantation","ALLOHA-2","Mismatched unrelated donors MMUD","ALLOHA","HA-1","TSC-100","Reduced Intensity Conditioning","RECRUITING","2026-07-10",{"date":51,"type":52},"2026-07-13","ACTUAL",{"date":54,"type":52},"2022-11-01",{"date":56,"type":20},"2028-06",{"name":58,"class":59},"TScan Therapeutics, Inc.","INDUSTRY",21,{"id":62,"slug":4,"hasResults":11,"nctId":12,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":24,"conditions":69,"keywords":72,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100475667","A Study of TSC-100 and TSC-101 in AML, ALL and MDS in Patients Undergoing Allogeneic Peripheral Blood Stem Transplantation","A Controlled Multi-Arm Phase 1 Umbrella Study Evaluating the Safety and Feasibility of T-Cell Receptor Engineered Donor T-Cells Targeting HA1 (TSC-100) or HA2 (TSC-101) in HLA-A0201 Positive Patients Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation","Inclusion Criteria:\n\n* Male or female aged ≥ 18 years at the time of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG)-PS ≤ 2 at the time of the screening visit.\n* Contraceptive use by male and female participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Male Participants:\n* A male participant must agree to use a highly effective contraceptive as detailed in Appendix 4 of this protocol during the intervention period and for at least 12 months after the last dose of study intervention and refrain from donating sperm during this period.\n* Female Participants:\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n* Not a woman of childbearing potential (WOCBP) OR\n* A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 12 months after the last dose of study intervention.\n* Preparing to undergo allogeneic HCT for either of the following:\n* AML\n* MDS\n* ALL\n* Participants in the treatment arms must express HLA-A\\*0201. Participants in the control arm may express any HLA type.\n* Having the HA1+\u002F- or HA-1+\u002F+ (HA-1 positive) genotype to be eligible for TSC-100 treatment.\n* Having the HA2+\u002F- HA-2+\u002F+ (HA-2 positive) genotype to be eligible for TSC-101 treatment.\n* Having a haploidentical donor, MMUD, or MUD for HCT who is adequately HLA-matched by institutional standards and meets the donor inclusion criteria.\n* Considered to be clinically indicated for haploidentical donor, MMUD, or MUD transplantation at the discretion of the treating investigator.\n* Considered to be clinically indicated for RIC at the discretion of the treating investigator.\n* Considered to be clinically indicated for peripheral blood stem cell transplantation at the discretion of the treating investigator.\n* Organ function parameters for transplant eligibility are met per institutional standards.\n* Capable of giving signed informed consent - which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Participants must provide consent for mandatory study procedures including bone marrow biopsy and blood sampling for research analyses in the ICF.\n* Participants must agree to participate in long-term follow-up for up to 15 years post initial product treatment if they are enrolled in the study and receive the investigational Tcell infusion.\n\nDonor Inclusion Criteria :\n\n* Male or female aged ≥ 18 years at the time of signing the informed consent.\n* Able to undergo peripheral blood stem cell (PBSC) collection and up to 2 rounds of leukapheresis (for TSC-100 or TSC101 manufacturing for treatment arms only, and f for stem cell collection for both treatment arms and the control arm).\n* Donors matched to TSC-100 participants should be HA-1-\u002F- (negative) and\u002For negative for all HLA-A\\*02 alleles\n* Donors matched to TSC-101 participants should be negative for all HLA-A\\*02 alleles\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\n* Medical or psychological conditions that would make the participant an unsuitable candidate for cell therapy including another concurrent uncontrolled malignancy or active CNS disease.\n* The presence of organ toxicities will not necessarily exclude participants from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA1\u002FHA2 TCRT cells may be required at the discretion of the treating investigator\n* Participants with levels of donor-specific HLA antibodies that are considered by the treating investigator to be high enough to warrant desensitization protocols and who have no alternate donors.\n* Participants who meet inclusion criteria for TSC-101 but who are also positive for HLAA\\*02:07.\n* Participants with evidence of clinically significant infection or uncontrolled viral r reactivation of cytomegalovirus (CMV), Epstein-Barr virus (EBV), Adenovirus, BK virus (BKV), or human herpesvirus 6 (HHV-6).\n* Participants with active cardiac disease, defined as:\n* Uncontrolled or symptomatic angina within the past 3 months.\n* History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes). Atrial fibrillation with controlled ventricular response on treatment is not an exclusion.\n* Myocardial infarction \\\u003C 3 months from study entry.\n* Uncontrolled or symptomatic congestive heart failure.\n* Prior allogeneic HCT.\n* Participants who have a history of hypersensitivity to murine proteins.\n* Enrollment on a concomitant trial with a novel investigational agent.\n* Use of anti-thymocyte globulin, alemtuzumab, or other in vivo T-cell depleting agents from Day -14 through end of study.\n\nDonor Exclusion Criteria :\n\n* Donors for TSC-100 positive for any HLA-A\\*02 allele would be excluded unless they are HA-1 negative. If donors with any HLA-A\\*02 allele are considered for patients eligible for TSC-100, the donor would undergo HA-1 testing to ensure that the donor is HA-1 negative (40% probability).\n* Donors for TSC-101 positive for any HLA-A\\*02 allele are excluded regardless of HA- 2 status.\n* Donors who test positive for any of the following: HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection, syphilis, West Nile virus through central lab testing. Donors who screen positive for risk of CreutzfeldtJakob disease or Zika virus infection using donor history questionnaires will also be excluded. Donors with evidence of past CMV or EBV infections will be allowed.\n* Related donor residing outside of the United States of America (USA). If the donor screening, testing and leukapheresis can be performed at the same site where the participant is being treated, the donor is considered eligible.",{"count":67,"type":20},75,[23],[26,70,71],"Myelodysplastic Syndromes","ALL, Adult",[45,29,46,30,26,27,16,31,32,33,34,35,36,37,38,47,39,40,41,44,43],"2026-04-02",{"date":75,"type":52},"2026-04-08",{"date":54,"type":52},{"date":78,"type":20},"2026-06",{"name":58,"class":59},15,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":101,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100561258","a-biospecimen-collection-study-to-identify-the-targets-of-disease-reactive-t-cells-in-patients-with-autoimmune-disease-100561258","NCT06587828","A Biospecimen Collection Study to Identify the Targets of Disease-Reactive T Cells in Patients With Autoimmune Disease","Cohort Legend: Cohort 1: Inflammatory Bowel Diseases - Crohn's Disease or Ulcerative Colitis, Cohort 2: Celiac Disease, Cohort 3: Ankylosing spondylitis or non-radiographic axial spondyloarthritis (nr-axSpA), Cohort 4: Multiple Sclerosis, Cohort 5: Scleroderma, Cohort 6: Systemic Sclerosis with pulmonary involvement, Cohort 7: Other Autoimmune Disease, Cohort 8: Apparent Evolving Autoimmune Disease, Cohort 9: Frozen Cryopreserved\n\nInclusion Criteria:\n\n* Study cohorts 1,2,3,4,5,6,7,8.9: Known or suspected diagnosis, with subsequent diagnostic confirmation, of one of the following cohorts associated with the following autoimmune diseases:\n* Inflammatory Bowel Diseases - Crohn's Disease or ulcerative colitis\n* Celiac disease\n* Ankylosing spondylitis or Non radiographic axial spondyloarthritis (nr-axSpA)\n* Multiple sclerosis\n* Scleroderma\n* Systemic sclerosis with pulmonary involvement\n* Other autoimmune disease (as agreed between Investigator and Sponsor)\n* Apparent evolving autoimmune disease\n* Frozen cryopreserved\n* Age equal or greater than 18 years at time of informed consent.\n* Ability to understand and willingness to sign an informed consent document when informed consent is required by an ethical review board.\n* On disease-modifying treatments that are not known to be directly T cell toxic.\n\nSuch treatments are allowed and include:\n\n* Non-steroidal anti-inflammatory drugs including aspirin, ibuprofen, acetaminophen, celecoxib, indomethacin, diclofenac, etodolac, naproxen, meloxicam, sulindac, nabumetone amongst others.\n* Tumor necrosis factor alpha (TNF-alpha) antagonists including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi) and biosimilar drugs with the same generic name.\n* Interleukin-12\u002F23 antagonists including ustekinumab (Stelara) and risankizumab-rzaa (Skyrizi)\n* Alpha-4-integrin antagonists including vedolizumab (Entyvio), natalizumab (Tysabri)\n* Interleukin-17 inhibitors including secukinumab (Cosentyx), ixekizumab (Taltz)\n* Recombinant interferon beta\n* CD20 antagonists including rituximab (Rituxan), ocrelizumab (Ocrevus), ofatumumab (Kesimpta)\n* Oral fumarates including dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), monomethyl fumarate (Bafiertam)\n* Oral sphingosine 1-phosphate receptor (S1PR) modulators including fingolimod (Gilenya), siponimod (Mayzent), ozanimod (Zeposia), ponesimod (Ponvory)\n* Oral glatiramer acetate (copolymer 1; Copaxone)\n* Patient is an appropriate candidate for a procedure to obtain a biopsy, tissue samples or biologic materials during a clinically indicated procedure where it is expected that excess materials could be used for research OR\n* In the opinion of the clinical investigator, a patient is an appropriate, low-risk candidate for a research only procedure to obtain a biopsy, tissue samples or biologic materials.\n\nExclusion Criteria:\n\n* On treatment with drugs that are known to be T cell toxic and cannot be held for at least 4 weeks or longer. The following treatments are not allowed except in designated cohorts when approved by Sponsor:\n* Glucocorticoids including prednisone, methylprednisolone (Solu-medrol), budesonide (Entocort), hydrocortisone (Solu-cortef), dexamethasone (Decadron), betamethasone (Betaject)\n* Sulfasalazine (Azulfidine)\n* Aminosalicylates including mesalamine\u002F mesalazine (Asacol, Pentasa).\n* Thiopurines including azathioprine (Imuran) and 6-mercaptopurine (Purixan)\n* Systemic JAK inhibitors including tofacitinib (Xeljanz), abrocitinib (Cibinqo), baricitinib (Olumiant), upadacitinib (Rinvoq)\n* CD52 inhibitors including alemtuzumab (Campath)\n* Methotrexate\n* Cladribine\n* Teriflunomide (Aubagio)\n* Concurrent disease or condition that would make the patient inappropriate for study participation, or any serious medical or psychiatric disorder that would interfere with the subject's safety.\n* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n* Patients receiving research biopsy procedures will not have a history of serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine), if local anesthetic is required for the procedure or to medications used for sedation during a procedure.\n* Pregnant or nursing women are excluded because there may be unanticipated adverse events and increased risk to both mother and fetus in the setting of local anesthetic or study procedures.\n* Any other medical or psychiatric condition, which in the opinion of the patient's treating clinician, would make participation in this protocol unreasonably hazardous for the patient.",{"count":88,"type":20},300,"OBSERVATIONAL","The most clinically meaningful way to discover new targets of T cells in autoimmune diseases is to study the tissues of patients with active autoimmune disease mediated organ inflammation. These tissues contain both cytotoxic and helper T cells that are driving their disease, and these T cells are being guided by TCRs that recognize tissue-specific targets. By collecting tissue when a patient has active inflammation, it is possible to determine which T cells are activated and undergoing clonal expansion in the patient's diseased organ. TScan has developed a genome-wide, high-throughput technology to determine the natural, physiological target of any TCR (Kula, 2019). The goal of this study is to isolate T cells from inflamed tissues and matched blood samples and\u002For matched normal tissues (for patients with inflammatory bowel diseases). T cell clones that are expanded in diseased tissues relative to blood or normal tissues will be selected and the targets of their TCRs will be defined using TScan's genome-wide, high-throughput target ID technology.\n\nThe goal of this study is to discover a collection of peptide targets, along with their associated TCRs to be developed as new tolerogenic therapies for patients with autoimmune diseases.",[92,93,94,95,96,97,98,99,100],"Autoimmune Diseases","Ulcerative Colitis","Multiple Sclerosis","Scleroderma","Ankylosing Spondylitis","Celiac Disease","Non-radiographic Axial Spondyloarthritis (Nr-axSpA)","Crohn&Amp;#39;s Disease","Birdshot Chorioretinitis",[92,94,102,96,95,103,104,105,100],"Systemic Sclerosis","Inflammatory Bowel Disease","Crohn's Disease","Non-radiographic axial spondyloarthritis (nr-axSpA)","2025-11-21",{"date":108,"type":52},"2025-11-24",{"date":110,"type":52},"2023-01-03",{"date":112,"type":20},"2027-01",{"name":58,"class":59},12,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100591154","a-long-term-follow-up-study-of-tscan-tcr-t-products-100591154","NCT06976736","A Long Term Follow-up Study of TScan TCR-T Products","A Long-term Follow-up Study to Assess Safety in Participants Who Received an Investigational T-Cell Receptor Engineered T-Cell (TCR-T) Product","LTFU","Inclusion Criteria:\n\n* Participants who received a TCR-T cellular therapy in a clinical study sponsored by TScan Therapeutics.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* None","110 Years",{"count":125,"type":20},1000,"The purpose of this Long-Term Follow-Up (LTFU) study is to monitor participants who have previously received TSC-100 or TSC-101 TCR-T therapies in the TSCAN-001 study. Participants will be monitored for 15 years from the date of TCR-T cell therapy administration to assess long-term safety and efficacy.",[26,16,27],[129,130,131,132,30,46,133],"TSCAN","Cell Therapies","TCR-T Cell Therapy","Long Term Follow-Up (LTFU)","TSCAN-001","2025-09-02",{"date":136,"type":52},"2025-09-10",{"date":138,"type":20},"2025-09-09",{"date":140,"type":20},"2040-09",{"name":58,"class":59},2,""]