[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-solid-tumors":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,85,107,131,153],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100342530","natural-history-and-biospecimen-acquisition-for-children-and-adults-with-rare-solid-tumors-100342530",false,"NCT03739827","Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors","Natural History and Biospecimen Acquisition Study for Children and Adults With Rare Solid Tumors","* INCLUSION CRITERIA:\n* Cohort 1: Participants with a diagnosis of a rare solid tumor (fewer than 15 cases in 100,000 people per year). There are no age restrictions beyond the neonatal period (4 weeks).\n\nOR\n\n-Cohort 2: Participants without a rare tumor who have a germline genetic variant that predisposes to a rare solid tumor\n\nOR\n\n-Cohort 3: Relatives of participants with diagnosis of rare solid tumors who do NOT have a known germline variant that predisposes to a rare solid tumor\n\nOR\n\n* Cohort 4: Parent\u002Fguardian of child participating in a focus group if not already enrolled on the study.\n* Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nNone",true,"ALL","4 Weeks",{"count":20,"type":21},10000,"ESTIMATED","OBSERVATIONAL","Background:\n\nApproximately 150 cases of cancer per one million per year are considered rare cancers. While all tumors originate from genetic changes, a small percentage of these tumors are familial. Researchers want to study these changes in biological samples from people with rare tumors in order to learn more about how these tumors develop. The information obtained from this study may lead to improved screening, preventive guidelines, and treatments.\n\nObjective:\n\nTo better understand rare cancers and hereditary cancer syndromes.\n\nEligibility:\n\nPeople who have a rare tumor, a family history of a rare tumor, a hereditary cancer syndrome, or a mutation that leads to rare tumors.\n\nDesign:\n\nParticipants will be screened with questions about their medical history and\u002For that of their family members. They will give a saliva sample.\n\nParticipants who have a tumor will have their medical records and tests reviewed. They will answer questions about their wellbeing and needs. They may provide a tumor tissue sample.\n\nParticipants may also have:\n\n* Physical exam\n* Clinical photography\n* Blood, urine, saliva, and stool samples taken\n* Consultation with specialists\n* A scan that produces a picture of the body. Either one that uses a small amount of radiation, or one that uses a magnetic field.\n* Genetic testing\u002Fgenetic counseling.\n\nParticipants will be contacted once a year. They will answer updated questions about their medical and family history.\n\nParticipants will be asked to contact the study team if there are changes in their tumors.\n\nParticipants may be invited to join focus groups for people with the same diagnosis of rare tumors.\n\nParticipants may be invited to participate in other NIH protocols.\n\n\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\n\n\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\n\nRARE TUMOR LIST:\n\n1. Acinar cell carcinoma of the pancreas\n2. Adamantinoma\n3. Adenosqaumous carcinoma of the pancreas\n4. Adrenocortical carcinoma\n5. Alveolar soft part sarcoma\n6. Anaplastic Thyroid Cancer\n7. Angiosarcoma\n8. Atypical Teratoid Rhabdoid Tumor\u002FMRT\n9. Carcinoid\n10. Carcinoma of Unknown Primary\n11. Chondrosarcoma\n12. Chondromyxoid fibroma\n13. Chordoma\n14. Clear cell renal carcinoma\n15. Clear Cell Sarcoma\n16. Clear cell sarcoma of kidney\n17. Conventional chordoma\n18. Dedifferentiated chordoma\n19. Desmoid\n20. Desmoplastic small round cell tumor\n21. Epithelioid hemangioendothelioma\n22. Esthenioneuroblastoma\n23. Ewing Sarcoma\n24. Fibrolamellar carcinoma\n25. Fusion negative rhabdomyosarcoma\n26. Fusion positive renal cell carcinoma\n27. Fusion positive rhabdomyosarcoma\n28. Gastro-enteropancreatic neuroendocrine tumor\n29. Hepatoblastoma\n30. Hereditary Diffuse Gastric Cancer\n31. Inflammatory myofibroblastic tumor\n32. Kaposiform hemangioendothelioma\n33. Malignant ectomesenchymal tumor\n34. Malignant peripheral nerve sheath tumor\n35. Malignant triton tumor\n36. Medullary thyroid cancer\n37. Mixed acinar adenocarcinoma\n38. Mixed acinar neuroendocrine carcinoma\n39. Myxoid Liposarcoma\n40. Neuroblastoma\n41. Neuroendocrine tumors\n42. NUT midline carcinoma\n43. Osteosarcoma\n44. Pancreas ductal adenocarcinoma with squamous features\n45. Pancreatic acinar cell carcinoma\n46. Papillary renal cell carcinoma\n47. Paraganglioma\n48. Parosteal Osteosarcoma\n49. Periosteal Osteosarcoma\n50. Peripheral nerve sheath tumor\n51. Peripheral primitive neuroectodermal tumor\n52. Pheochromocytoma\n53. Pituitary cancer\n54. Poorly differentiated chordoma\n55. Renal medullary carcinoma\n56. Rhabdomyosarcoma\n57. Round cell Liposarcoma\n58. Schwannoma\n59. Sclerosing Epithelioid Fibrosarcoma\n60. SDH deficient GIST\n61. SMARCB1 deficient tumors\n62. SMARCA4 deficient tumors\n63. Synovial sarcoma\n64. Undifferentiated Sarcoma\n\n    \\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\n\n    \\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*",[25,26,27,28,29],"Malignant Solid Tumors","Other Neoplasms Solid Tumors","Pediatric Solid Tumor","Refractory Solid Tumors","Solid Tumor",[31,32,33,34],"Service to the Patients","Knowledge about the Nature of Cancer","Cancer Evaluations","Natural History","RECRUITING","2026-06-23",{"date":38,"type":39},"2026-06-24","ACTUAL",{"date":41,"type":39},"2019-01-28",{"date":43,"type":21},"2032-03-31",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",3,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100571548","phase-1-peel-224-vincristine-and-temozolomide-in-pediatric-solid-tumors-100571548","NCT06721689","PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors","A Phase 1\u002F2 Clinical Trial of the Novel Topoisomerase I Inhibitor PEEL-224 as a Single Agent and in Combination With Vincristine and Temozolomide in Children With Refractory, Progressive or Relapsed Solid Tumors","PEEL-224","Inclusion Criteria:\n\n1. Age:\n\n   * Phase 1: Age greater than or equal to 1 year and less than or equal to18 years\n   * Phase 2 Neuroblastoma (NBL) cohort: Age greater than or equal to 1 year and less than or equal to 30 years\n   * Phase 2 Rhabdomyosarcoma (RMS) cohort: Age greater than or equal to 1 year and less than or equal to18 years\n2. Diagnosis of:\n\n   * Phase 1: Refractory, progressive or relapsed non-central nervous system (CNS) solid tumors who have received at least 1 line of upfront therapy. Patients must have had histologic verification of their malignancy at original diagnosis or relapse\n   * Phase 2: Refractory, progressive or relapsed neuroblastoma (NBL) or rhabdomyosarcoma (RMS) who have received at least 1 line of upfront therapy. Patients must have had histologic verification of their malignancy at original diagnosis or relapse.\n3. Disease status:\n\n   * Phase 1: evaluable or measurable disease\n   * Phase 2, subjects with Neuroblastoma (NBL): evaluable or measurable disease by International Neuroblastoma Response Criteria (INRC); subjects with only bone marrow disease are not eligible\n   * Phase 2, subjects with rhabdomyosarcoma (RMS): measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)1.1.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 (age greater than 16 years) or Lansky Performance Status of at least 60 (age less than 16 years).\n5. Females of childbearing potential must have a negative urine\u002Fserum pregnancy test.\n6. Adequate bone marrow function\n\n   Hematologic requirements for all subjects on phase 1 and subjects on phase 2 without malignant infiltration of the bone marrow:\n   * Absolute neutrophil count (ANC) greater than or equal to 750\u002Fmm3 (greater than or equal to 7 days since last dose of short acting myeloid growth factor medications (e.g. filgrastim) and greater than or equal to 14 days since last dose of long-acting myeloid medications (e.g. peg-filgrastim)\n   * Platelet count ≥ 75,000 mm3 (greater than or equal to 14 days since last dose of thrombopoietin receptor agonist such as romiplostim and without platelet transfusion within previous 7 days)\n   * Not refractory to packed red blood cell transfusions\n\n   Hematologic requirements for subjects on phase 2 with malignant infiltration of the bone marrow:\n   * Absolute neutrophil count (ANC) greater than or equal to 500\u002Fmm3 (greater than or equal to 7 days since last dose of short acting myeloid growth factor medications (e.g. filgrastim) and greater than or equal to 14 days since last dose of long-acting myeloid medications (e.g. peg-filgrastim))\n   * Platelet count greater than or equal to 50,000\u002Fmm3 (greater than or equal to 14 days since last dose of thrombopoietin receptor agonist such as romiplostim and without platelet transfusion within previous 7 days)\n   * Not refractory to packed red blood cell transfusions\n   * Patients on phase 2 with malignant infiltration of the bone marrow will not be evaluable for hematologic toxicity.\n7. Adequate renal function as evidenced by creatinine clearance as calculated by the Schwartz equation (see below), radioisotope glomerular filtration rate (GFR) greater than or equal to 70 mL\u002Fmin\u002F1.73 m2, or maximum serum creatinine as below:\n\n   Age Maximum Serum Creatinine (mg\u002FdL)\n\n   Male Female 1 to less than 2 years 0.6 0.6 2 to less than 6 years 0.8 0.8 6 to less than 10 years 1 1 10 to less than 13 years 1.2 1.2 13 to less than 16 years 1.5 1.4 greater than 16 years 1.7 1.4 Threshold derived from the Schwartz formula for estimating glomerular filtration rate (GFR) (Schwartz et al., J.Peds, 106:522,1985) utilizing child length and stature data published by the CDC The Schwartz equation for subjects less than 18 years of age: eGFR (mL\u002Fmin\u002F1.73 m2) = 0.413 x \\[height (cm)\u002Fserum creatinine (mg\u002FdL)\\]\n8. Adequate liver function\n\n   * Aspartate Aminotransferase (AST\u002FSGOT): less than or equal to 3 times the upper limit of normal (ULN) or less than or equal to 5 the upper limit of normal if attributable to disease involvement. For the purpose of this study, the upper limit of normal (ULN) for Aspartate Aminotransferase (AST) is 50 U\u002FL.\n   * Alanine Aminotransferase (ALT\u002FSGPT): less than or equal to 3 times the ULN or less than or equal to 5 the upper limit of normal if attributable to disease involvement. For the purpose of this study, the upper limit of normal (ULN) for Alanine Aminotransferase (ALT) is 45 U\u002FL.\n   * Total bilirubin: less than or equal to 1.5 times the upper limit of normal with the exception of patients with Gilbert's syndrome who must have bilirubin less than 3X institutional upper limit of normal (ULN).\n9. Prior Therapy: Patients must have had resolution of acute toxic effects of prior therapy to grade less than or equal to 1 according to the National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 5.0 except organ function as noted above, adverse events (AE) that are considered clinically non-significant (i.e. alopecia), or controlled on supportive care (i.e. nausea\u002Fvomiting, hypothyroidism). Patients must meet the following minimum washout periods prior to enrollment:\n\n   * Myelosuppressive chemotherapy: At least 14 days after the last dose of myelosuppressive chemotherapy\n   * Small molecule targeted therapy: At least 7 days following the last dose of a small molecule targeted agent.\n   * Antibody therapy: At least 21 days following the last dose of antibody including anti-GD2 monoclonal antibody.\n   * Cellular therapy: At least 42 days following completion of a cellular therapy agent (e.g. modified T cells, NK cells, dendritic cells)\n   * Autologous hematopoietic stem cell transplant and stem cell boost: Subjects must be at least 60 days from day 0 of an autologous stem cell transplant or stem cell boost.\n   * Myeloid growth factors: At least 7 days following short-acting myeloid growth factor (e.g. filgrastim) and at least 14 days following the last dose of long-acting myeloid growth factor (e.g. peg-filgrastim)\n   * Thrombopoietin receptor agonists: At least 14 days following last dose of thrombopoietin receptor agonist such as romiplostim\n   * Interleukins, interferons, and cytokines (other than hematopoietic growth factors): At least 21 days following the completion of interleukins, interferon, or cytokines, including IL-2\n   * Radiotherapy:\n\n     * At least 14 days after limited field radiation therapy;\n     * At least 90 days after total body irradiation, craniospinal radiotherapy; or radiation to greater than 50% of pelvis;\n     * At least 42 days must have elapsed if other substantial BM radiation.\n   * Radiopharmaceutical therapy (e.g. radiolabeled antibody, 131I- MIBG): At least 42 days after radiopharmaceutical therapy\n   * Major Surgery: At least 2 weeks from prior major surgical procedure. Note: Biopsy, CNS shunt placement\u002Frevision, and central line placement\u002Fremoval are not considered major.\n   * Strong CYP1A2 and\u002For CYP3A4 inhibitors and\u002For inducers: At least 14 days following use of a strong CYP1A2 and\u002For CYP3A4 inhibitor and\u002For inducer. See Appendix 1 for examples. (Note that levofloxacin is permitted when clinically indicated)\n10. Prior treatment with irinotecan and\u002For temozolomide is permitted.\n11. Female patients of reproductive potential must agree to use a highly effective contraceptive method for the duration of study therapy and for at least six months after the final dose of PEEL-224. Males of reproductive potential with a female partner of child-bearing potential must use a highly effective for the duration of the study and for at least six months after the final dose of PEEL-224.\n12. Subjects must agree to use sun protective measures while receiving treatment and for 4 weeks after the last dose of PEEL-224\n13. Parental\u002Fguardian permission (informed consent) and if appropriate, child assent.\n\nExclusion Criteria:\n\n1. Prior treatment with PEEL-224.\n2. Subjects receiving any other anti-cancer agents.\n3. Subjects with primary central nervous system (CNS) solid tumors or central nervous system (CNS) metastatic disease.\n4. Subjects with prior allogeneic stem cell or solid organ transplantation.\n5. Pregnant or lactating females.\n6. Subjects with a known history of human immunodeficiency virus (HIV), hepatitis B, and\u002For hepatitis C (testing not required as part of screening).\n7. Subjects with symptomatic congestive heart failure.","1 Year","30 Years",{"count":59,"type":21},59,"INTERVENTIONAL",[62,63],"PHASE1","PHASE2","The phase 1 primary objective is to determine the pediatric recommended phase 2 dose (RP2D) of PEEL-224 as a single agent (phase 1A) and in combination with vincristine and temozolomide (phase 1B). The phase 2 primary objective is to estimate the objective response rate (ORR) in children with refractory, progressive and relapsed NBL and rhabdomyosarcoma (RMS) treated with the RP2D of PEEL-224 in combination with vincristine and temozolomide.",[28,66,67,68,69,70],"Relapsed Solid Tumors","Relapsed Neuroblastoma","Refractory Neuroblastoma","Relapsed Rhabdomyosarcoma","Refractory Rhabdomyosarcoma",[72,73,29],"Relapsed","Refractory","2026-06-12",{"date":76,"type":39},"2026-06-15",{"date":78,"type":39},"2025-03-23",{"date":80,"type":21},"2031-04",{"name":82,"class":83},"Theodore Laetsch","OTHER",7,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":60,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100516573","phase-1-a-phase-ib-trial-of-eribulin-in-combination-with-irinotecan-and-temozolamide-in-children-with-relapsed-or-refractory-solid-tumors-100516573","NCT06006273","A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors","Inclusion Criteria:\n\n* Age: Patients must be \\> 1 year of age and ≤ 25 years of age at time of initiation of protocol therapy.\n* Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory solid tumor.\n* Disease Status: Patients must have evaluable disease.\n* Patients may have CNS metastases at study entry, if they are previously treated or stable (defined by not requiring initation or increased steroids for 7 days).\n* Performance Level: Karnofsky ≥ 50% for patients \\>16 years old, and Lansky ≥ 50 for patients 1-16 years old. (Appendix I)\n* Prior Therapy: Patients may have received prior therapy including single-agent irinotecan or temozolomide. Patients may not have previously been treated with combination therapy of irinotecan and temozolomide.\n* Patients must be fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n\n  1. Hematopoietic growth factor: At least 7 days must have elapsed since the last administration of filgrastim, or 14 days since administration of pegfilgrastim.\n  2. XRT: At least 7 days since the last dose of local palliative radiation therapy. Greater than 6 months must have elapsed since the last day of treatment if given total body irradiation, craniospinal irradiation.\n  3. Autologous or Allogenic Stem Cell Transplant: Complete resolution of graft versus host disease and no current need for immunosuppressive medication. Greater than 3 months must have elapsed since engraftment and no longer requiring transfusion of platelets or injection of colony stimulating factors.\n\n     * Organ Function Requirements\n* Bone Marrow Function:\n\n  1. Peripheral absolute neutrophil count (ANC) ≥ 750\u002FµL\n  2. Platelet count ≥ 75,000\u002FµL (no platelet transfusion within 7 days prior to obtaining laboratory result)\n* Adequate Renal Function:\n\n  a. Creatinine clearance or glomerular filtration rate ≥ 70ml\u002Fmin\u002F1.73m2 (calculated or measured as appropriate for age and level of concern by treating MD)\n* Adequate Liver Function:\n\n  1. Total bilirubin ≤ 1.5x upper limit of normal (ULN) for age\n  2. SGPT (ALT) ≤ 3 x ULN\n  3. Serum albumin ≥ 2gm\u002FdL Due to the risk of hepatic injury, including fatal hepatic failure, temozolomide should not be administered if total bilirubin is \\>2.0 mg\u002Fdl or SGPT(ALT)\\> 3 x ULN.\n\nInformed Consent: All patients ≥ 18 years of age must sign a written informed consent. For patients \\\u003C 18 years old, the patient's parents or legal guardians must sign a written informed consent, unless the patient is an emancipated minor. Childhood Assent, when age appropriate as per institutional guidelines, should be signed by the participating patient. Consent may be obtained virtually, as per institutional guidelines.\n\nExclusion Criteria:\n\n* Significant organ dysfunction, not meeting inclusion criteria.\n* Pediatric subjects who are considered wards of some entity\n* Pregnancy or Breast-Feeding\n* Pregnant or breast-feeding woman will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies.\n* Concomitant Medications:\n* Growth factor: Growth factors that support platelet or white cell number of function must not have been administered within the past 7 days.\n* Investigational Drugs: Patients who are currently receiving another investigational drug. (Please refer to Prior Therapy, section 2.1.5)\n* Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents. (Please refer to Prior Therapy, section 2.1.5.1)\n* Medication Allergy:\n\n  1. Allergy or intolerance to agents on this protocol: irinotecan, temozolomide, or eribuin\n  2. Allergy to cephalosporins, without a reasonably available antibiotic alternative\n* Infection: Patients who have uncontrolled infection, positive blood cultures within the past 48 hours, or receiving treatment for Clostridium difficile infection.","25 Years",{"count":93,"type":21},48,[62],"To find the recommended dose of eribulin that can be given in combination with irinotecan and temozolomide to treat relapsed and\u002For refractory solid tumors.",[28],"2026-05-18",{"date":99,"type":39},"2026-05-20",{"date":101,"type":39},"2023-08-16",{"date":103,"type":21},"2028-12-31",{"name":105,"class":83},"M.D. Anderson Cancer Center",1,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":60,"phases":118,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":106},"100527638","early-phase-1-personalized-ksx01-tcrt-in-patients-with-advanced-solid-tumors-100527638","NCT06150365","Personalized KSX01-TCRT in Patients With Advanced Solid Tumors","Single Arm Clinical Study on the Safety and Efficacy of Personalized KSX01-TCRT in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Screening period 1- inclusion criteria:\n\nPatients should complete all examinations for screening period 1 within 28 days after signing the informed consent form. Only those who meet the inclusion criteria for this stage can collect fresh tumor tissue, 2-3 archived pathological tissue white slides, and peripheral blood for TCR sequence screening and HLA typing testing.\n\n1. Volunteer to participate in clinical research; Fully understand this study and voluntarily sign an informed consent form; Willing to follow and capable of completing all testing procedures.\n2. Age range from 18 to 70 years old (including boundary values).\n3. Solid tumors that have been confirmed by histological or cytological evaluation as incurable or metastatic, and have failed standard treatment or currently have no available standard treatment.\n4. Expected survival time\\>6 months.\n5. ECOG score 0 or 1.\n6. Having sufficient organ function, defined as follows:\n\n   6.1) Hematology: 6.1.1) Hemoglobin 90 g\u002FL (no blood transfusion received within 14 days prior to examination); 6.1.2) Absolute value of neutrophils 1.5 109\u002FL (did not receive granulocyte colony stimulating factor treatment within 14 days prior to examination); 6.1.3) Platelet count is 100 109\u002FL in the absence of obvious liver lesions (primary or metastatic) (platelet transfusion not received within 14 days before examination), or 75 109\u002FL in the presence of liver lesions (platelet transfusion not received within 14 days before examination); 6.1.4) Absolute lymphocyte count (ALC) 0.7 109\u002FL; 6.2) Liver function: 6.2.1) Total bilirubin (TBIL) ≤ 1.5 in the absence of obvious liver lesions (primary or metastatic) × Upper limit of normal (ULN), subjects with liver lesions or Gilbert disease ≤ 3 × ULN; 6.2.2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (liver metastasis or liver cancer subjects can be ≤ 5 × ULN); Alkaline phosphatase (ALP) ≤ 2.5 × ULN (bone metastasis subject, ALP ≤ 5) × ULN); 6.3) Renal function: Creatinine clearance rate ≥ 60 mL\u002Fmin (Cockcroft Fault formula: \\[140 age\\] × Weight \\[kg\\] × \\[0.85, female only\\]\u002F(72 × Creatinine (mg\u002Fdl);\n\n   Subjects with a creatinine clearance rate of\\\u003C60 mL\u002Fmin but ≥ 50 mL\u002Fmin can also be enrolled if all of the following conditions are met:\n\n   Serum creatinine and blood urea nitrogen (BUN) are within the normal range of the research center No clinical evidence showing chronic renal dysfunction (such as acidosis or electrolyte disorders) The urine routine and urine output are within the normal range of the research center Note: It is not recommended to use IL-2 during the treatment period for subjects with a baseline creatinine clearance rate of\\\u003C60 mL\u002Fmin.\n7. The patient's HLA-I class molecule IHC expression is positive.\n8. Patients with tumor lesions that can be collected and can screen out TCR sequences that can be used as drugs can enter the study. If the patient has obtained personalized TCR sequences using previously collected and archived tumor tissue in other studies, they can directly enter screening period 2, but the collection time of the archived tissue should be within one year before signing the informed consent for this study.\n9. The patient agrees to receive peripheral monocyte collection after all tests in screening period 1 meet the standards.\n\n   * Screening period 2- inclusion criteria:\n\nAfter receiving confirmation notification of TCR sequence locking from the partner, or if the patient has obtained their personalized TCR sequence in other studies, they can be arranged to undergo various inclusion evaluations in screening period 2.\n\nThe organ function and key examination items of the patient at this stage should not have significant changes compared to the examination results in screening period 1. If the patient's examination results during screening period 2 exceed the following criteria, peripheral monocyte collection should not be performed until the abnormal items return to normal range.\n\nScreening period 2- Routine inclusion criteria\n\n1. Confirmed screening and locking of tumor specific TCR sequences from the patient's own body. For patients who have obtained TCR sequences through other research projects, they should sign an informed consent form for this research project before entering screening period 2.\n2. Expected survival time\\>6 months.\n3. ECOG score 0 or 1.\n4. Having sufficient organ function, defined as follows:\n\n4.1) Hematology: 4.1.1) Hemoglobin 90 g\u002FL (no blood transfusion received within 14 days prior to examination); 4.1.2) Absolute value of neutrophils is 1.0 109\u002FL (did not receive granulocyte colony stimulating factor treatment within 14 days before the examination); 4.1.3) Platelet count is 75 109\u002FL in the absence of obvious liver lesions (primary or metastatic) (platelet transfusion was not received within 14 days before the examination); 4.1.4) Absolute lymphocyte count (ALC) 0.7 109\u002FL; 4.2) Liver function: 4.2.1) Total bilirubin (TBIL) ≤ 1.5 in the absence of obvious liver lesions (primary or metastatic) × Upper limit of normal (ULN), subjects with liver lesions or Gilbert disease ≤ 3 × ULN; 4.2.2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (liver metastasis or liver cancer subjects can be ≤ 5 × ULN); Alkaline phosphatase (ALP) ≤ 2.5 × ULN (bone metastasis subject, ALP ≤ 5) × ULN); 4.3) Renal function: Creatinine clearance rate ≥ 60 mL\u002Fmin (Cockcroft Fault formula: \\[140 age\\] × Weight \\[kg\\] × \\[0.85, female only\\]\u002F(72 × Creatinine (mg\u002Fdl);\n\nSubjects with a creatinine clearance rate of\\\u003C60 mL\u002Fmin but ≥ 50 mL\u002Fmin can also be enrolled if all of the following conditions are met:\n\nSerum creatinine and blood urea nitrogen (BUN) are within the normal range of the research center No acidosis or electrolyte disorders The urine routine and urine output are within the normal range of the research center Note: It is not recommended to use IL-2 during the treatment period for subjects with a baseline creatinine clearance rate of\\\u003C60 mL\u002Fmin.\n\n4.4) The patient naturally breathes (without assisted oxygen supply) with a basal blood oxygen saturation of\\>92%.\n\nAgree to accept peripheral monocyte collection. 6) Women of childbearing age who have the ability to conceive have a negative blood pregnancy test within 7 days before the first cell infusion (non fertility: surgical sterilization or at least 2 years after menopause), and the subjects of childbearing age use medically recognized contraceptive measures from the start of research treatment (chemotherapy) to 5 months after the last cell infusion, and no eggs have been retrieved during this period.\n\n7\\) Male participants are willing to take medically approved contraceptive measures within 5 months after signing the informed consent form and the last cell infusion, and do not donate sperm during this period.\n\n8\\) According to the iRECIST standard, there is at least one measurable lesion present. The following situations require approval from the researcher:\n\n* During the dose increasing stage, subjects only have evaluable lesions but can evaluate their efficacy through their serum tumor markers;\n* The subjects currently do not have measurable lesions, but the researchers have determined that they may develop or become measurable lesions within one month.\n\n  9\\) The toxicity and adverse reactions caused by frontline treatment should be restored to Grade 1 (excluding clinically insignificant toxicity, such as hair loss caused by chemotherapy).\n\nExclusion Criteria:\n\n* Screening period 1- Exclusion criteria:\n\nSubjects who meet any of the following criteria shall not participate in this clinical study:\n\n1. The patient has received systemic chemotherapy on line 3 or above:\n\n   Patients can be enrolled during the first line systemic chemotherapy, during the second line systemic chemotherapy period, or after the end of the second line systemic chemotherapy (enrollment time is screening period 2 and meets the standards and receives clearance chemotherapy), but they cannot receive the third line systemic chemotherapy before enrollment:\n   * The second and third line systemic chemotherapy is defined as a systematic chemotherapy regimen after the progression of frontline treatment;\n   * For patients who complete neoadjuvant chemotherapy in the early stage of their disease, their neoadjuvant chemotherapy regimen can include up to two types of chemotherapy;\n   * For patients who meet all other inclusion criteria but have a large number of frontline treatment lines, they can also be included after evaluation and confirmation by the researchers.\n\n   Frontline treatment plans targeting biological agents (such as immune checkpoint inhibitors), small molecule targeted drugs, etc., are not considered as exclusion criteria.\n2. Within two years before signing the informed consent, the patient had a medical history of other malignant tumors, except for non melanoma skin cancer, some cancers in situ (such as cervical cancer, bladder cancer, breast cancer), or low-risk prostate cancer.\n3. Clinically confirmed liver diseases, including active hepatitis virus infection, alcoholic hepatitis, other types of hepatitis, cirrhosis, and hereditary liver diseases; Among them, the subject's\n\n   * Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) are positive, and the hepatitis B virus DNA (HBV DNA) in the peripheral blood is higher than the lower detection limit of the research center;\n   * HCV-Ab positive and HCV-RNA above the lower detection limit of the research center Patients who can effectively control HBV-DNA and\u002For HCV-RNA after treatment can also be included in the group after being evaluated and approved by the researcher. HBV-DNA positive subjects should receive hepatitis B treatment after signing the informed consent form and continue to receive KSX01-TCRT infusion for at least 6 months. Such subjects should also monitor their HBV-DNA and hepatitis B related antigen antibodies on Day28 and at each follow-up visit point.\n4. History of myocardial infarction, history of cardiac bypass surgery, unstable angina, active atrial fibrillation requiring treatment, symptomatic sinus bradycardia (heart rate\\\u003C50 beats\u002Fmin), or other clinically significant heart diseases within 6 months prior to signing the informed consent form.\n5. Tumor lesions invading the heart or large blood vessels. The patient has permanent percutaneous nephrostomy, catheterization, bile duct, and other indwelling tubes, except for those that the researchers believe can be removed before gonorrhea clearance.\n\n7\\) Primary immune deficiency. 8) HIV positive; Active HBV or HCV infection. 9) Received allogeneic stem cell transplantation within 6 months before signing the informed consent form.\n\n10\\) Prior to signing the informed consent form, CAR T cell therapy or other genetically modified T cell therapy other than this research technique was received.\n\n11\\) Known allergies to dimethyl sulfoxide (DMSO) or any other cellular formulation components and potential therapeutic drugs used during treatment (such as cyclophosphamide, fludarabine, and tolumab).\n\n12\\) History of autoimmune diseases, except for the following:\n\n-A history of hypothyroidism and the use of stable thyroid hormone replacement therapy;\n\n-Patient has controllable type 1 diabetes 13) The patient's illness or condition results in their lack of understanding, participation, and\u002For adherence to this study plan.\n\n14\\) Any other disease that researchers believe will impair the subject's tolerance to the treatment regimen or significantly increase the risk of complications.\n\n15\\) Known history of alcohol abuse, psychotropic substance abuse, or drug use. 16) Have a clear history of neurological or mental disorders in the past, such as epilepsy, dementia, schizophrenia, etc.\n\n17\\) According to the judgment of the researchers, the underlying condition of the subjects may increase their risk of receiving investigational drug treatment, or may cause confusion in the interpretation of toxic reactions and adverse events that may occur.\n\nOther researchers believe that it is not suitable to participate in this study.\n\n* Screening Period 2- Exclusion Criteria\n\nSubjects who meet any of the following criteria shall not undergo peripheral monocyte collection:\n\n1. Before monotherapy, the subject's anti-tumor treatment was not fully eluted (2 weeks or 5 half-lives, whichever is shorter):\n\n   -Except for the following situations: Gonadotropin (GnRH) agonists or antagonists used for the treatment of prostate cancer Hormone replacement therapy or oral contraceptives.\n2. Known primary central nervous system (CNS) malignant tumors or symptomatic CNS metastases.\n\n   If the patient is diagnosed with a central nervous system disease and meets the following conditions with the consent of the main researcher, it is not considered an exclusion item:\n   * There are measurable or evaluable lesions outside the CNS;\n   * No history of intracranial or spinal cord bleeding;\n   * There is no need for ongoing or planned corticosteroid treatment within 14 days prior to enrollment;\n   * Receiving stable doses of anticonvulsants;\n   * No stereotactic radiation or whole brain radiation therapy was received within 14 days prior to enrollment.\n3. Women during pregnancy or lactation.\n4. Receiving or planning to receive systemic corticosteroid therapy (\\>5 mg of prednisone or equivalent treatment medication per day) or immunosuppressive drugs within 7 days prior to monotherapy, except for the following:\n\n   * Intranasal, inhalation, topical steroids, or local administration (such as intra articular injection);\n   * Physiological doses of systemic steroids as an alternative therapy (such as physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction);\n   * Steroids are used as prophylactic drugs for hypersensitivity reactions (such as computed tomography \\[CT\\] prophylactic drugs).\n5. The first second forced expiratory volume (FEV1)\u002Fforced vital capacity (FVC)\\\u003C70% during lung function examination indicates abnormal lung function.\n6. According to the judgment of the researchers, the underlying condition of the subjects may increase their risk of receiving investigational drug treatment, or may cause confusion in the interpretation of toxic reactions and adverse events that may occur.\n7. There are severe infections within 2 weeks before single collection. Major surgery (excluding diagnostic surgery) is performed within 4 weeks prior to single collection, or is expected to be performed during the study period. Subjects can be enrolled in planned or ongoing minor surgical procedures, such as establishing venous channels.","18 Years","70 Years",{"count":117,"type":21},12,[119],"EARLY_PHASE1","This trial is a single arm, open phase I clinical study to investigate the safety and efficacy of personalized KSX01-TCRT in patients with advanced solid tumors. This experiment is divided into two parts: the dose increasing stage (Part A) and the dose expanding stage (Part B). For those enrolled in the planned expansion phase, the dose should have passed the safety assessment during the dose escalation phase.",[28,66],"2025-03-24",{"date":124,"type":39},"2025-03-26",{"date":126,"type":39},"2023-11-07",{"date":128,"type":21},"2028-12-01",{"name":130,"class":83},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":138,"targetDuration":4,"studyType":60,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":150,"locationsCount":106},"100501647","early-phase-1-ksx01-tcrt-injection-project-in-solid-tumors-100501647","NCT05811975","KSX01-TCRT Injection Project in Solid Tumors","IIT Clinical Trial on Tolerance, Safety, and Preliminary Efficacy of KSX01-TCRT Injection in Solid Tumor Subjects","Inclusion Criteria:\n\n* 1\\) Voluntary participation in clinical research; Fully understand the study and voluntarily sign an informed consent form; Willing to follow and capable of completing all test procedures.\n* 2\\) Age: 18 to 70 years old (including boundary value).\n* 3\\) Malignant solid tumors that have failed standard treatment or currently have no standard treatment available.\n* 4\\) Patients with tumor lesions that can be punctured and can be screened for a pharmaceutically acceptable TCR sequence can be enrolled in the study.\n* 5\\) Remission from previous surgical or treatment related adverse events to a level of 0-1, stable, or acceptable for inclusion\u002Fexclusion criteria (according to NCI CTCAE Version 5.0), or to an acceptable level for inclusion\u002Fexclusion criteria; Except for other toxicity that researchers believe does not pose a safety risk to the subject, such as hair loss, pigmentation, and peripheral neuropathy.\n* 6\\) Adequate organ function (without medical support such as blood transfusion, granulocyte colony stimulating factor, etc. during pre harvest and baseline periods) is defined as follows:\n* 6.1) Blood system:\n* 6.1.1) Hemoglobin 90 g\u002FL (no blood transfusion or erythropoietin treatment within 14 days before the first administration);\n* 6.1.2) The absolute value of neutrophils is 1.5 109\u002FL (no treatment with granulocyte colony stimulating factor or granulocyte macrophage colony stimulating factor within at least 14 days before chemotherapy);\n* 6.1.3) Platelet count is 100 109\u002FL in the absence of significant liver lesions (primary or metastatic), or 75 109\u002FL in the presence of liver lesions (no platelet transfusion, thrombopoietin, or interleukin-11 treatment was received within 14 days before the first administration);\n* 6.1.4) Absolute lymphocyte count (ALC) 0.7 109\u002FL;\n* 6.2) Liver function:\n* 6.2.1) Total bilirubin (TBIL) ≤ 2.0 in the absence of significant liver lesions (primary or metastatic) × Upper limit of normal (ULN), subjects with liver lesions or Gilbert disease ≤ 3 × ULN；\n* 6.2.2) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 × ULN (liver metastasis or hepatocellular carcinoma can be ≤ 5 × ULN）； Alkaline phosphatase (ALP) ≤ 2.5 × ULN (bone metastasis subject, ALP ≤ 5 × ULN）；\n* 6.3) Renal function:\n* 6.3.1) Creatinine clearance ≥ 50 ml\u002Fmin (Cockcroft Gault formula: (\\[140 age\\] × Body weight \\[kg\\] × \\[0.85, female only\\])\u002F(72 × Creatinine (mg\u002Fdl));\n* 6.3.2) Qualitative determination of urinary protein ≤ 1+; If the qualitative analysis of urine protein is ≥ 2+, a 24-hour urine protein quantitative test is required. If the 24-hour urine protein quantitative analysis is\\\u003C1 g, it is acceptable;\n* 6.4) Coagulation function: Activated partial thromboplastin time and international standardized ratio of 1.5 in patients who did not receive anticoagulant therapy × ULN, or patients receiving anticoagulation therapy, have a stable anticoagulation treatment regimen; Patients with liver metastasis or liver cancer are acceptable 2 × ULN。\n* 7\\) The Eastern United States Cancer Collaborative Group (ECOG) score for physical fitness is 0-1.\n* 8\\) The expected survival period is ≥ 12 weeks.\n* 9\\) According to the RECIST 1.1 standard, there is at least one evaluable lesion (dose increasing stage) or measurable lesion (dose expanding stage).\n* 10\\) After evaluation, sufficient PBMC cells can be collected from the subjects to prepare autologous TCR-T cells; The peripheral superficial venous blood path of the subject is unobstructed, suitable for single blood collection and separation, with sufficient venous access to collect cells, and can meet the requirements of intravenous infusion.\n* 11\\) After evaluation, the prepared autologous TCR-T cells are sufficient in quantity and qualified in quality, and can be used for corresponding doses of clinical reinfusion.\n* 12\\) \"The blood pregnancy test for women of childbearing age within 7 days before the first cell transfusion was negative, and the subjects of childbearing age used medically approved contraceptives from the beginning of research treatment (chemotherapy) until 1 year after the last cell transfusion, and no eggs were recovered during this period.\".\n* 13\\) Male subjects are willing to take medically approved contraceptive measures within 6 months after signing the informed consent form and the last cell transfusion, and do not donate sperm during this period.\n\nExclusion Criteria:\n\n* 1\\) A history of severe allergic diseases, allergies to severe drugs (including unlisted investigational drugs), or known allergies to any component of the drugs recommended for use in this protocol (including pre-treatment drugs).\n* 2\\) Persons who have previously received treatment with other cell\u002Fgene products.\n* 3\\) Evidence of significant bleeding or coagulation disorders or other significant bleeding risks:\n* 3.1) Previous history of intracranial hemorrhage or spinal cord hemorrhage;\n* 3.2) Tumor lesions that invade large blood vessels and have a significant risk of bleeding;\n* 3.3) Thrombosis or embolism occurred within 6 months before cell transfusion;\n* 3.4) Clinically significant hemoptysis or tumor bleeding occurred within 1 month before cell reinfusion;\n* 3.5) Within 2 weeks before cell reinfusion, anticoagulation therapy for therapeutic purposes has been used (except for those requiring a stable treatment regimen and judged appropriate by the researcher).\n* 4\\) Within 28 days before enrollment, there were no healed wounds, ulcers, or fractures.\n* 5\\) The following treatments or drugs have been received before enrollment, pre harvest, pre clearance, or cell reinfusion:\n* 5.1) Have received any live or attenuated vaccine within 4 weeks before enrollment, or are expected to receive live or attenuated vaccine during the study period;\n* 5.2) Preharvest use of any cytotoxic chemotherapy or small molecule targeted therapy\\\u003C2 weeks or 5 half lives, whichever is longer;\n* 5.3) Have undergone major surgery (excluding diagnostic surgery) within 4 weeks before single collection, or are expected to undergo major surgery during the study period;\n* 5.4) Planned systemic use (if long-term use is expected) of systemic steroids (\\>10 mg\u002Fday of prednisone or equivalent), hydroxyurea, and immunomodulators (e.g.: α or γ Interferons, GM-CSF, mTOR inhibitors, cyclosporin, thymosin, etc.), this standard is not applicable when the following conditions occur:\n\n  * Intranasal, inhalation, topical steroids, or local steroid injections (such as intra articular injections);\n  * Physiological doses of systemic steroids as an alternative therapy (such as physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction);\n  * Steroids are used as prophylaxis for hypersensitivity reactions (such as computed tomography (CT) prophylaxis).\n* 5.5) The washout period of previous anticancer treatment before the first administration of the study drug is insufficient, as defined below:\n\n  * Any cytotoxic chemotherapy or small-molecule targeted therapy\\\u003C2 weeks or 5 half lives, whichever is shorter, except for clearance chemotherapy;\n  * Endocrine therapy\\\u003C3 weeks;\n  * Monoclonal antibody or other biological therapy\\\u003C3 weeks;\n  * Herbal therapy with anti-tumor indications\\\u003C2 weeks;\n  * Whole brain radiotherapy\\\u003C2 weeks, or stereotactic brain radiotherapy\\\u003C1 week;\n  * More than 30% of bone marrow radiotherapy or accompanied by wide field irradiation for\\\u003C4 weeks, or palliative radiotherapy for\\\u003C2 weeks.\n* 6\\) Patients with systemic bone metastases.\n* 7\\) A history of leptomeningeal cancer.\n* 8\\) Brain metastases or spinal cord compression, unless asymptomatic, or symptoms stabilize after treatment and do not require treatment with steroids and anticonvulsants for at least 2 weeks prior to the first administration of the study drug.\n* 9\\) Presence of any form of primary immune deficiency.\n* 10\\) Subjects with any active autoimmune disease, or a history of autoimmune disease, and expected recurrence (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), vasculitis, invasive lung disease, and asthma requiring medical intervention with bronchodilators). The following cases are excluded: type 1 diabetes; Skin diseases that do not require systemic treatment \\[such as vitiligo, psoriasis, alopecia, Grave's disease, Hashimoto's disease, psoriasis patients\\]; Hypothyroidism requiring only hormone replacement therapy; Asthma that has completely remitted in childhood does not require any intervention in adulthood; Or other people who are not expected to have a relapse without external triggers.\n* 11\\) Active liver or biliary disease (excluding Gilbert syndrome or asymptomatic gallstones, liver metastases, or other stable chronic liver disease, as assessed by the investigator).\n* 12\\) Within 6 months before cell reinfusion, the following conditions occurred: myocardial infarction, severe\u002Funstable angina, clinically significant arrhythmias requiring clinical intervention, cerebrovascular accident\u002Fstroke, transient ischemic attack, subarachnoid hemorrhage, and cardiac insufficiency with a New York Heart Association (NYHA) rating of ≥ II.\n* 13\\) There is currently uncontrolled pleural, pericardial, and abdominal effusion.\n* 14\\) Before cell reinfusion, there are:\n* 14.1) Congenital long QT syndrome;\n* 14.2) Using a cardiac pacemaker;\n* 14.3) Received coronary artery reconstruction;\n* 14.4) Acute coronary syndrome (angina pectoris or myocardial infarction, within 6 months before signing the informed consent form);\n* 14.5) The electrocardiogram showed clinically significant abnormalities or an average QTcF of\\>450 ms for men and\\>470 ms for women (\\>480 ms for patients with bundle branch block (BBB)) in three consecutive times (at least 5 minutes between each time interval);\n* 14.6) Severely uncontrollable diabetes;\n* 14.7) Hypertension with poor drug control (systolic blood pressure\\>160 mmHg and\u002For diastolic blood pressure\\>90 mmHg);\n* 14.8) Severe aortic stenosis or symptomatic mitral stenosis;\n* 14.9) Interstitial pneumonia or pulmonary fibrosis can be seen on chest radiographs (subjects with pneumonia due to radiation are not excluded, but they cannot rely on oxygen);\n* 14.10) Any other disease that the researcher believes will impair the subject's tolerance to the treatment regimen or significantly increase the risk of complications;\n* 15\\) During screening or before cell transfusion, fever of unknown origin\\>38.5 ° C occurred (according to the judgment of the researcher, fever caused by tumor can be included in the group).\n* 16\\) There are severe active viral and bacterial infections, or uncontrolled systemic fungal infections within 4 weeks prior to enrollment, single collection, and pre treatment with cleaning and administration.\n* 17\\) Virological examination results (HIV, Treponema pallidum antibody Tp-Ab) were positive.\n* 18\\) Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive, and hepatitis B virus DNA (HBV-DNA) is higher than the lower limit of detection in the research center; HCV-Ab is positive and HCV-RNA is higher than the lower detection limit of the research center.\n* 19\\) It is expected that any other form of anti-tumor drug treatment will be required during the study period after cell transfusion.\n* 20\\) There is a known history of organ transplantation.\n* 21\\) Women during pregnancy or lactation.\n* 22\\) Known history of alcohol abuse, psychotropic substance abuse, or drug abuse.\n* 23\\) Have a clear history of neurological or mental disorders, such as epilepsy, dementia, schizophrenia, etc.\n* 24)According to the judgment of the researcher, the underlying condition of the subject may increase the risk of receiving treatment with the investigational drug, or may cause confusion in the interpretation of the toxic reactions and adverse events that occur.\n* 25\\) Other situations where the researcher considers it inappropriate to participate in this study.",{"count":139,"type":21},50,[119],"1\\) Safety and efficacy of TCR-T cells in subjects with refractory\u002Frelapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.",[143,28,66],"TCR-T Cells","2023-03-31",{"date":146,"type":39},"2023-04-13",{"date":148,"type":39},"2023-03-07",{"date":103,"type":21},{"name":151,"class":152},"TCRx Therapeutics Co.Ltd","INDUSTRY",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":161,"targetDuration":4,"studyType":60,"phases":162,"briefSummary":141,"conditions":163,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":106},"100480734","early-phase-1-ksh01-tcrt-solid-tumors-100480734","NCT05539833","KSH01-TCRT Solid Tumors","A Single-arm, Prospective Clinical Study of KSH01-TCR-T in the Treatment of Refractory\u002FRecurrent Solid Tumors","KSH01-TCRT","1. Inclusion Criteria:\n\n   * Voluntarily participate in clinical research; fully understand this research and sign informed consent voluntarily; be willing to follow and have the ability to complete all experimental procedures;\n   * Male or female, aged 18 to 70 years (inclusive);\n   * Subjects with advanced malignant solid tumors confirmed by histology or cytology;\n\n     * Dose escalation phase: subjects who have no standard treatment, or who have failed or relapsed after standard treatment, or who cannot tolerate standard treatment with positive target expression;\n     * Dose expansion phase: target-positive subjects who progressed on first-line therapy;\n   * HLA-A\\*02 positive and tumor target positive (target tumor cell staining intensity is divided into 0, 1+, 2+, 3+, \\>30% of cancer cells express 2+ or 3+ positive positive for the target)\n   * All toxicities caused by previous anti-tumor therapy were relieved to grade 0-1 (according to NCI CTCAE version 5.0) or to an acceptable level for inclusion\u002Fexclusion criteria. Except for other toxicities such as alopecia and vitiligo that the researchers believe do not pose a safety risk to the subjects;\n   * Sufficient organ function (without receiving medical support such as blood transfusion and granulocyte colony-stimulating factor within 14 days before cell reinfusion), defined as follows:\n   * Blood system:\n\n     * The neutrophil count (ANC) is not lower than the lower limit of the normal value of the center;\n     * White blood cells (WBC) are not lower than the lower limit of the normal value of the center;\n     * Platelet count (PLT) is not lower than the lower limit of normal value in our center;\n     * Hemoglobin (Hb) not less than 0.8\\*LLN (lower limit of normal);\n   * Liver function:\n\n     * Total bilirubin (TBIL) ≤ 2.0 × upper limit of normal (ULN), Gilbert disease subjects should be ≤ 3 × ULN;\n     * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤3×ULN (in the dose expansion phase, subjects with liver metastases or liver cancer can be ≤5×ULN); alkaline phosphatase (ALP) ≤2.5× ULN (subjects with bone metastases, ALP≤5×ULN);\n   * Renal function:\n\n     * Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml\u002Fmin (Cockcroft-Gault formula: (\\[140-age\\]×weight \\[kg\\]×\\[0.85, for women only\\])\u002F(72×creatinine (mg\u002Fdl)));\n     * The qualitative urine protein is ≤1+; if the qualitative urine protein is ≥2+, a 24-hour urine protein quantitative examination is required, and if the 24-hour urine protein quantitative \\\u003C1 g, it is acceptable;\n   * Coagulation function:\n\n   Those who did not receive anticoagulation therapy: International normalized ratio (INR), activated partial thromboplastin time (APTT) should be less than or equal to 1.5×ULN; patients with liver metastasis or liver cancer should be less than or equal to 2×ULN;\n   * Physical status: Eastern Cooperative Oncology Group (ECOG) score of 0-1;\n   * Expected survival period ≥ 12 weeks;\n   * According to RECIST 1.1 criteria, there is at least one measurable lesion (dose expansion phase) or an evaluable lesion (dose escalation phase);\n   * After assessment, enough PBMC cells can be collected in the subject to prepare autologous TCR-T cells;\n   * After evaluation, the prepared autologous TCR-T cells are of sufficient quantity and qualified quality, and can be used for clinical reinfusion of the corresponding dose;\n   * Female subjects with fertile potential have a negative blood pregnancy result within 3 days before the cell reinfusion, and are willing to abstain from sex or take medically approved high-efficiency drugs from the time of signing the informed consent to 6 months after the end of the last medication. contraceptive measures (eg, IUDs, condoms);\n   * Male subjects are willing to keep abstinence or take medically approved high-efficiency contraceptive measures from the time of signing the informed consent to 6 months after the end of the last medication, and do not donate sperm during this period.\n   * All subjects are required to provide tumor tissue specimens that can be used for target analysis, which must be archived specimens or fresh biopsy specimens (bone biopsy specimens are not accepted). Only those with positive target expression can enter the study.\n2. Exclusion Criteria:\n\n   * History of severe allergic diseases, severe drug allergy (including unmarketed test drugs), or known allergy to any component of the recommended drugs (including pretreatment drugs) in this program;\n   * Those who have received coronary artery reconstruction in the past;\n   * Evidence of significant bleeding disorders or other significant bleeding risk:\n   * History of intracranial hemorrhage or intraspinal hemorrhage;\n   * Tumor lesions invade large blood vessels and have obvious bleeding risk;\n   * Thrombosis or embolism occurred within 6 months before cell reinfusion;\n   * Clinically significant hemoptysis or tumor hemorrhage occurred within 1 month before cell reinfusion;\n   * Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) has been used within 2 weeks before cell reinfusion;\n   * Antiplatelet drugs, such as aspirin (\\>325 mg\u002Fday), clopidogrel (\\>75 mg\u002Fday), dipyridamole, ticlopidine or cilostazine, were used within 10 days before cell reinfusion azoles, etc.;\n   * Received the following treatments or drugs before cell reinfusion:\n\n     * Unhealed wounds, ulcers or fractures within 28 days before cell reinfusion;\n     * Inoculated with live attenuated vaccine within 28 days before cell reinfusion;\n     * Received nitrosourea or mitomycin C treatment within 6 weeks before cell infusion; received oral fluorouracil treatment 2 weeks before cell infusion or within ●half-lives of the drug (whichever is longer) ;\n   * Received corticosteroids within 2 weeks before cell reinfusion, or it is expected that corticosteroid treatment may be required during blood collection, cell collection or cell reinfusion; except for the following cases: short time (≤7 days), dose not higher than 10 mg\u002Fd prednisone or equivalent dose of corticosteroids for the prevention or treatment of non-autoimmune conditions; topical, intranasal, intraocular, intraarticular or inhaled corticosteroids;\n   * Known leptomeningeal metastases, or uncontrolled or symptomatic central nervous system metastases manifested by clinical symptoms, cerebral edema, spinal cord compression, and\u002For progressive growth. Subjects with a history of central nervous system metastasis or spinal cord compression are acceptable if they have clearly received treatment and are clinically stable after 8 weeks of discontinuation of anticonvulsants and steroids before cell reinfusion;\n   * The existence of any form of primary immunodeficiency;\n   * There is any active autoimmune disease, or there is a history of autoimmune disease and relapse is expected (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, need for bronchial Asthma subjects medically intervened with dilators, except for the following: type 1 diabetes; skin conditions not requiring systemic therapy \\[eg, vitiligo, psoriasis, alopecia\\]; hypothyroidism only receiving hormone replacement therapy; childhood Asthma in complete remission without any intervention in adulthood; or others not expected to relapse in the absence of external triggers);\n   * Within 6 months before cell reinfusion, the following conditions have occurred: myocardial infarction, severe\u002Funstable angina, clinically significant arrhythmia requiring clinical intervention, cerebrovascular accident\u002Fstroke, transient ischemic attack, Subarachnoid hemorrhage, cardiac insufficiency with New York Heart Association (NYHA) class ≥ II;\n   * There is currently uncontrollable pleural, pericardial, and ascites effusion;\n   * Before cell reinfusion, there are:\n\n     * Congenital Long QT Syndrome\n     * Use of a pacemaker\n     * Left Ventricular Ejection Fraction (LVEF) \\\u003C 50%\n     * QTcF interval\\>480 msec (QTcF=QT\u002F(RR\\^0.33))\n     * Cardiac troponin I or T \\>2.0 ULN\n     * Poorly controlled diabetes (fasting blood glucose ≥ 13.3 mM)\n     * Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg);\n     * Forced expiratory volume in the first second (FEV1) ≤ 60% or those who need supplemental oxygen therapy;\n   * Unexplained fever \\>38.5°C during screening or before cell reinfusion (fever due to tumor can be included in the group as judged by the investigator);\n   * Known history of allogeneic organ transplantation;\n   * Known history of alcohol abuse, psychotropic substance abuse or drug abuse;\n   * Have a clear history of neurological or mental disorders, such as epilepsy, dementia, schizophrenia, etc.;\n   * Known to have acquired immunodeficiency syndrome (AIDS);\n   * Known severe active viral, bacterial infection, or uncontrolled systemic fungal infection;\n   * Positive virological test results (HIV, CMV, HSV, HPV, EBV, syphilis);\n   * HBsAg positive or HBcAb positive, and HBV-DNA \\> 200 IU\u002FmL; HCV-Ab positive, and HCV-RNA higher than the detection limit of the research center;\n   * According to the judgment of the investigator, the underlying condition of the subject may increase the risk of receiving the experimental drug treatment, or cause confusion in the interpretation of the toxic reactions and adverse events;\n   * Expected to receive any other form of antitumor drug treatment during the study period;\n   * Women who are pregnant or breastfeeding;\n   * Other investigators deem it inappropriate to participate in this study.",{"count":139,"type":21},[119],[143,28,66],{"date":165,"type":39},"2023-04-03",{"date":167,"type":39},"2022-08-19",{"date":169,"type":21},"2027-07-31",{"name":151,"class":152}]