[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"all-acute-b-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:all-acute-b-lymphoblastic-leukemia":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,55,83,108,132],{"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":25,"conditions":26,"keywords":34,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100426707","phase-1-study-of-efficacy-and-safety-of-crc01-in-adult-large-b-cell-lymphoma-and-b-cell-acute-lymphoblastic-leukemia-patients-100426707",false,"NCT04836507","Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients","An Open-label, Multi-center, Single-arm Phase 1\u002F2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia","Cohort A:\n\nInclusion Criteria:\n\n1. ≥ 19 years of age and provided written informed consent\n2. Histologically confirmed following large B-cell lymphomas according to the World Health Organization classification 2017\n\n   * Diffuse large B-cell lymphoma, not otherwise specified Including Large cell transformation from follicular lymphoma (Transformed follicular lymphoma)\n   * High-grade B-cell lymphoma, not otherwise specified\n   * High-grade B-cell lymphoma with double-hit\u002Ftriple-hit\n   * Primary mediastinal large B cell lymphoma\n3. Relapsed or refractory disease after ≥ two lines of chemotherapy including rituximab, anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT) or being ineligible for or not consenting to ASCT.\n4. At least one measurable lesion (Long diameter ≥ 1.5cm)\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n6. Adequate renal and hepatic functions based on the laboratory test results\n\n   * Total Bilirubin ≤ 2.0mg\u002FdL with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ≤ 3 X ULN and direct bilirubin ≤ 1.5 X ULN.\n   * Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 3 X Upper Limit of Normal (ULN) for age with exception of liver metastasis; patients with liver metastasis may be included if their AST and ALT are ≤ 5 X ULN.\n   * Serum creatinine ≤ 1.5 X ULN\n   * Estimated Glomerular Filtration Rate (eGFR) ≥ 60mL\u002Fmin\u002F1.73m2\n7. Adequate hematologic function without transfusions within 2 weeks prior to screening for the study defined as followings:\n\n   * Hemoglobin \\> 8.0g\u002F㎗\n   * Absolute Neutrophil Count (ANC) \\> 1,000\u002F㎕\n   * Absolute Lymphocyte Count (ALC) ≥ 300\u002F㎕\n   * Platelets ≥ 50,000\u002F㎕\n8. Must have a minimum level of pulmonary reserve defined as;\n\n   * ≤ Grade 1 dyspnea per Common terminology criteria for adverse events (CTCAE) v5.0\n   * pulse oxygenation \\> 91% on room air\n9. Hemodynamically stable, without pericardial effusion and Left Ventricle Ejection Fraction (LVEF) ≥ 50% confirmed by Echocardiogram (ECG) or Multigated Radionuclide Angiography (MUGA)\n10. Must have an apheresis product of non-mobilized cells accepted for manufacturing\n11. Life expectancy ≥ 12 weeks\n12. Women of child-bearing potential and all male participants must agree to use highly effective methods of contraception for at least 12 months following CRC01 infusion and until CRC01 are no longer present by PCR on two consecutive tests\n\nExclusion Criteria:\n\n1. Patients with the following medical history\n\n   * Previous or concurrent malignancy with the following exceptions:\n\n     * Adequately treated basal cell or squamous cell carcinoma without evidence of recurrence for at least 3 years prior to the study\n     * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study\n     * A primary malignancy which has been completely resected and in complete remission for ≥ 5 years\n   * Unstable angina and\u002For myocardial infarction within 12 months prior to screening\n   * Thromboembolic events, pulmonary embolism or bleeding diatheses within 6 months prior to screening\n   * Hypoxemia, significant pleural effusion or significant EKG findings within 6 months prior to the screening\n2. Patients with the following concurrent disease at screening:\n\n   * Central Nervous System (CNS) involvement by malignancy by MRI at screening\n   * Active infection with hepatitis B (HBsAg positive. But, in case of HBcAb IgG positive, the patient can be enrolled in this study if he\u002Fshe takes prophylactic anti-viral agent.)\n   * Active infection with hepatitis C (HCV RNA positive)\n   * Human immunodeficiency virus (HIV) positive\n   * Active neurological auto-immune or inflammatory disorder (e.g. Guillain Barre Syndrome, Amyotrophic Lateral Sclerosis)\n   * Ventricular tachycardia and atrial fibrillation with rapid ventricular response not controlled with medical treatment within 3 months prior to screening\n3. Rapidly progressing the disease as per investigator's discretion\n4. Had major surgery requiring general anesthesia or mechanical ventilation within 4 weeks prior to screening (For video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery can be applied with within 2 weeks prior to screening.)\n5. Severe infection requiring anti-bacterial, anti-fungal or anti-viral medication or uncontrolled active infection\n6. The following treatment history is excluded:\n\n   * Prior treatment with any prior anti-CD19\u002Fanti-CD3 therapy or any other anti-CD19 therapy\n   * Prior treatment with any adoptive T cell therapy\n   * Treatment with any prior gene therapy product\n   * Prior allogeneic HSCT\n   * Patients on oral anticoagulation therapy\n7. Eligible for and consenting to ASCT\n8. Use of investigational medicinal product\u002Fdevice within 4 weeks prior to screening\n9. Pregnant or lactating women\n10. Hypersensitivity reaction to the excipients of CRC01 cell product\n11. The following treatments are excluded:\n\n    * Anti-neoplastic therapies including chemotherapy, biologic agents, retinoid therapy, radiotherapy, immune therapy, hormonal therapy, etc. other than lymphodepleting chemotherapy within 2 weeks of leukapheresis and within 2 weeks of CRC01 infusion\n    * Steroids: therapeutic doses of steroids must be stopped \\> 7 days prior to leukapheresis and \\> 5 days prior to CRC01 infusion. However, the following physiological replacement doses of steroids are allowed: \\\u003C 6 mg\u002Fm2\u002Fday hydrocortisone or equivalent\n    * Immunosuppression: any immunosuppressive medication must be stopped \\> 4 weeks prior to leukapheresis and \\> 4 weeks prior to CRC01 infusion\n    * Antibody use including anti-CD20 therapy within 4 weeks prior to CRC01 infusion\n    * CNS disease prophylaxis must be stopped \\> 1 week prior to CRC01 infusion (e.g. intrathecal methotrexate)\n\nCohort B :\n\nInclusion Criteria :\n\n1. ≥ 19 years of age and provided written informed consent to voluntarily participate in this trial\n2. Relapsed or refractory B-cell lymphoblastic leukemia with one of the following:\n\n   * Primary refractory: Newly diagnosed and refractory to 2 or more cycles of standard chemotherapy\n   * Relapsed within 12 months of the first complete remission\n   * Chemorefractory: Refractory to 1 cycle of chemotherapy conducted after relapse\n   * Relapsed after or refractory to two or more lines of chemotherapy\n   * Relapsed or refractory 100 days after allogeneic HSCT\n3. (within 4 weeks prior to screening) Blast of \\> 5% identified in the BM\n4. (within 4 weeks prior to screening) BM or peripheral blood blast confirmed CD19-positive.\n\n   Specifically, those with prior treatment with any other anti-CD19 therapy must be confirmed to show CD19 ≥ 90%.\n5. Philadelphia chromosome positive with one of the following:\n\n   * Unable to take tyrosine kinase inhibitors (TKIs) due to side effects\n   * Relapsed or refractory despite treatment with two or more TKIs\n6. ECOG performance status of 0-1\n7. Confirmed adequate hematologic function defined as follows:\n\n   * Absolute neutrophil count (ANC) ≥ 500\u002FμL. However, exceptions are made in cases where the Investigator determines that cytopenia is related to the leukemia and may be recovered with leukemia treatment.\n   * Platelet count ≥ 50,000\u002FμL. However, exceptions are made in cases where the Investigator determines that cytopenia is related to the leukemia and may be recovered with leukemia treatment.\n   * Absolute lymphocyte count ≥ 200\u002FμL\n8. Adequate renal and hepatic functions confirmed based on the laboratory test results:\n\n   * Total Bilirubin ≤ 2.0 mg\u002FdL (for patients with Gilbert-Meulengracht syndrome, total bilirubin ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN)\n   * AST and ALT ≤ 3 × ULN\n   * Serum creatinine ≤ 1.5 × ULN or eGFR\\* ≥ 45 mL\u002Fmin\u002F1.73 m2 \\*MDRD-GFR (mL\u002Fmin\u002F1.73 m2) = 186 × (serum creatinine)-1.154 × (age)-0.203 (× 0.742 for females)\n9. Confirmed to have a minimum level of pulmonary reserve according to the following criteria:\n\n   * ≤ Grade 1 dyspnea per CTCAE v5.0\n   * Pulse oxygenation \\> 91% on room air\n10. Hemodynamically stable, without pericardial effusion, and LVEF ≥ 50% confirmed by ECHO or MUGA scan at Screening\n11. Capable of obtaining through leukapheresis non-mobilized cells adequate for CRC01 manufacturing\n12. Life expectancy of ≥ 12 weeks\n13. Consented to comply with the site visit and test schedules for Primary Follow-up and Secondary Follow-up in accordance with the Protocol for the duration of the Study\n14. WOCBP or male subjects who are willing to use appropriate contraceptive methods\\* for at least 12 months following CRC01 treatment and until CRC01 is no longer detected through two consecutive PCR tests \\* Hormonal contraceptives, placement of intrauterine system, double barrier method (simultaneous use of contraceptive vaginal diaphragm or cervical cap and male condom, along with spermicide), sterilization (vasectomy, bilateral tubal ligation), etc.\n\nExclusion Criteria:\n\nPatients in Cohort B may not participate in this trial if any of the following criteria apply.\n\n1. Patients with the following medication or treatment history:\n\n   ① Donor lymphocyte infusion (DLI) within 4 weeks\n   * Graft-versus-host-disease (GVHD) treatment within four weeks (In case of maintaining medication for post-treatment prophylaxis, the decision on the subject's participation in the clinical trial may be made after contacting and consulting with the Sponsor's Medical Monitor.)\n\n     * Central nervous system (CNS) radiotherapy or intracerebrospinal antineoplastic therapy within eight weeks (However, intrathecal therapy for prophylaxis purposes is an exception) ④ Systemic salvage chemotherapy that includes TKI and blinatumomab for treatment of Philadelphia positive ALL within one week prior to Screening or five half-lives of the administered drug (whichever is shorter)\n\n       * Any prior anti-CD19 treatment (with the exception of blinatumomab) ⑥ History of neurological toxicity ≥ Grade 4 or cytokine release syndrome (CRS) ≥ Grade 4 per CTCAE during prior anti-CD19 treatment\n2. Patients with the following CNS abnormality:\n\n   ① CNS-3 disease, defined by WBC ≥ 5\u002FμL in CSF and confirmed presence of lymphoblast, with or without neurological symptoms\n\n   ② CNS-3 disease, defined by WBC \\\u003C 5\u002FμL in CSF and confirmed presence of lymphoblast, with neurological symptoms (cases of CNS-1 disease without evidence of leukemia involvement in CSF and CNS-2 disease without neurological symptoms may be enrolled)\n\n   ③ Current or prior history of CNS disorder, such as epilepsy\u002Fseizure, cerebrovascular ischemia\u002Fbleeding, dementia, cerebellar disorder, autoimmune disease with CNS invasion, posterior reversible encephalopathy syndrome (PRES) or cerebral edema\n3. Burkitt's lymphoma\u002Fleukemia per WHO Classification or chronic myelogenous leukemia lymphoid blast crisis\n4. Primary immunodeficiency\n5. Hereditary diseases (e.g., Fanconi anemia, Kostmann syndrome, and Shwachman-Diamond syndrome) or other bone marrow failure syndromes\n\n2\\. Common Exclusion Criteria\n\nSubjects in Phase 1 study and Phase 2 study may not participate in this trial if any of the following criteria apply.\n\n1. Patients with the following medical history:\n\n   * History of malignancy with the following exceptions:\n\n     • Basal cell or squamous cell skin cancer treated without relapse for at least three years prior to Screening\n\n     • In-situ carcinoma of the cervix or breast treated without relapse for at least 3 years prior to Screening\n     * Superficial bladder cancer treated without relapse for at least 3 years prior to Screening\n     * A primary malignancy which has been completely resected and in complete remission for ≥ 5 years\n\n       * Unstable angina and\u002For myocardial infarction within 12 months prior to Screening ③ Thromboembolic events, pulmonary embolism or bleeding diatheses within 6 months prior to Screening\n\n         * Hypoxemia, clinically significant pleural effusion or clinically significant ECG findings within 6 months prior to Screening\n2. Patients with the following concurrent disease at Screening:\n\n   * Central nervous system (CNS) involvement by malignancy by magnetic resonance imaging (MRI) at Screening. However, for Cohort B, subjects with malignant tumor metastasis to the brain parenchyma confirmed by MRI scan.\n\n     * Active infection with hepatitis B confirmed (HBsAg positive at Screening. But, in case of HBcAb IgG positive, the patient can be enrolled if he\u002Fshe takes prophylactic anti-viral agent.)\n\n       * Active infection with hepatitis C confirmed (HCV Ab tested positive at Screening. But, if screened negative for HCV RNA, the patient can be enrolled.) ④ Known human immunodeficiency virus (HIV) positive ⑤ Active neurological auto-immune or inflammatory disorder (e.g., Guillain Barre syndrome, amyotrophic lateral sclerosis) ⑥ Ventricular tachycardia and atrial fibrillation with rapid ventricular response not controlled (i.e., relapsed or symptomatic) with pharmacological treatment within three months prior to Screening\n3. Showing rapid progression of study disease as per Investigator's discretion\n4. Had major surgery requiring general anesthesia or mechanical ventilation within four weeks prior to Screening (for video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery, within two weeks prior to Screening)\n5. Severe infection requiring anti-bacterial, anti-fungal or anti-viral medication or uncontrolled active infection at Screening\n6. Use of other investigational medicinal products\u002Fdevices within 4 weeks prior to Screening\n7. Pregnant or lactating women\n8. Hypersensitivity reaction to the ingredients of the Investigational Product\n\nOther protocol-related inclusion\u002Fexclusion may apply.","ALL","19 Years",{"count":19,"type":20},91,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a multi-center, phase I\u002FII study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma and B-cell Acute Lymphoblastic Leukemia.",[27,28,29,30,31,32,33],"Relapsed Large B-cell Lymphoma","Refractory Large B-cell Lymphoma","Diffuse Large B-cell Lymphoma (DLBCL)","Primary Mediastinal Large B-Cell Lymphoma (PMBCL)","High-grade B-cell Lymphoma","Transformed Follicular Lymphoma (TFL)","ALL (Acute B-Lymphoblastic Leukemia)",[35,36,37,38,39,40,41],"CRC01","anti-CD19 CAR-T","CAR-T","CAR T cells","Chimeric antigen receptor","PD-1 knock down","TIGIT knock down","RECRUITING","2026-06-29",{"date":45,"type":46},"2026-07-01","ACTUAL",{"date":48,"type":46},"2021-03-02",{"date":50,"type":20},"2030-09-26",{"name":52,"class":53},"Curocell Inc.","INDUSTRY",2,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100645053","phase-1-blinatumomab-combined-with-low-dose-dli-as-maintenance-therapy-after-transplantation-for-b-all-100645053","NCT07677878","Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL","A Single-arm, Open-label, Phase I Clinical Study of Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL","Inclusion Criteria:\n\n* 1\\) Voluntary participation: The participant or legal guardian fully understands this clinical study, provides informed consent (ICF), and is willing\u002Fable to comply with all trial procedures.\n\n  2\\) Age: \\\u003C70 years old at screening, any gender. 3) Diagnosis: High-risk acute B-lymphoblastic leukemia (B-ALL) with MRD-negative status post-transplant. High-risk factors include:\n  * \\>CR1 status\n  * Pre-transplant MRD+ status\n  * Ph-like subtype\n  * KMT2A rearrangement\n  * Other high-risk cytogenetic\u002Fgenetic factors per ELN 2023 criteria. 4) Allergy: No history of severe allergies. 5) Liver function: ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 2 × ULN. 6) Renal function: Serum creatinine ≤ ULN. 7) Other conditions: Absence of uncontrolled infections or severe psychiatric disorders.\n\n    8\\) Performance status: ECOG score 0-3, with life expectancy ≥ 4 months. 9) MRD status: Bone marrow flow cytometry confirmed MRD-negative before enrollment.\n\n    10\\) Engraftment: Evidence of myeloid and platelet engraftment. 11) GVHD: No active graft-versus-host disease (GVHD).\n\nExclusion Criteria:\n\n* 1\\) Drug hypersensitivity\u002Fcontraindications: Patients with known allergies or contraindications to the investigational drug(s).\n\n  2\\) Pregnancy\u002Flactation: Pregnant or breastfeeding female patients. 3) Active infection\u002FGVHD: Patients with active infection or active graft-versus-host disease (GVHD).\n\n  4\\) Substance abuse: Patients with chronic heavy smoking or alcohol use that may interfere with clinical evaluation.\n\n  5\\) Impaired consent\u002Fcompliance: Patients unable to provide informed consent or comply with procedures due to psychiatric\u002Fneurological disorders.\n\n  6\\) Recent major surgery: Patients who underwent major organ surgery within the past 6 weeks.\n\n  7\\) Organ dysfunction:\n* Liver: ALT or AST \\> 2.5 × ULN; Total bilirubin \\> 2 × ULN\n* Kidney: Serum creatinine \\> ULN 8) Investigator judgment: Patients deemed ineligible by investigators (e.g., poor compliance, substance abuse).","18 Years","70 Years",{"count":65,"type":20},60,[23],"This prospective study will be conducted in high-risk B-ALL patients post-allo-HSCT. We propose to investigate the safety and therapeutic efficacy of blinatumomab plus low-dose DLI maintenance therapy, with the ultimate goal of enhancing long-term survival outcomes.",[33],[70,71,72],"high-risk B-cell ALL","Blinatumomab","donor lymphocyte infusion","2026-06-28",{"date":45,"type":46},{"date":76,"type":46},"2024-12-01",{"date":78,"type":20},"2028-12-01",{"name":80,"class":81},"Liping Dou","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":82},"100629086","early-phase-1-a-clinical-study-exploring-the-safety-efficacy-and-cell-metabolic-kinetics-of-universal-car-t-cell-injection-in-cd19-and--or-cd20-positive-relapsed--refractory-b-cell-acute-lymphoblastic-leukemia-in-adolescents-children-and-adults-100629086","NCT07470073","A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and \u002F or CD20 Positive Relapsed \u002F Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults","Inclusion Criteria:\n\n* voluntarily participate in clinical research; I fully understand and know this study and sign the informed consent form; ;\n* aged 12-75 years (inclusive);\n* relapsed \u002F refractory B-ALL diagnosed by morphology, immunology or molecular science, and meeting one of the following conditions:\n\n  1. The patients who did not achieve complete remission by the standardized induction chemotherapy, or early relapse (\\\u003C12 months) after complete remission, or late relapse (≥ 12 months) after complete remission, and did not achieve complete remission by the standardized one course induction chemotherapy (except for the patients with late relapse who did not have a better treatment or did not tolerate other treatments according to the investigator's assessment), relapsed after 2 or more CR or CRI;\n  2. For ph+all patients, in addition to receiving standard induction chemotherapy, they should also receive at least two kinds of TKI treatment without complete remission or relapse after complete remission (except those who cannot tolerate TKI treatment or have contraindications to TKI treatment, or those with T315I mutation do not need to receive TKI treatment);\n* CD19 and \u002F or CD20 positive in bone marrow or peripheral blood;\n* the proportion of bone marrow cell morphology or peripheral blood suggestive blasts ≥ 5%;\n* estimated survival \\>12 weeks;\n* study participants should meet the following inspection results (there should be no ongoing continuous supportive care):\n\n  1. Endogenous creatinine clearance ≥ 30 ml\u002Fmin (using Cockcroft Gault formula);\n  2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN; In case of hepatobiliary invasion: AST and alt ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN;\n  3. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n  4. Oxygen saturation in non oxygen inhalation state was \\> 91%;\n  5. Left ventricular ejection fraction (LVEF) ≥ 50%.\n* Male study participants who had active sex with women with reproductive potential were willing to use very effective and reliable methods of contraception within 1 year after receiving study treatment. All male study participants were absolutely forbidden to donate sperm within 1 year after receiving study treatment infusion during the study period.\n\nExclusion Criteria:\n\n* pregnant or lactating women;\n* there is HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA is higher than the detection limit), or active hepatitis C virus infection (both HCV antibody and HCV-RNA are positive);\n* there is currently any uncontrollable active infection, including but not limited to patients with active tuberculosis (judged by the investigator);\n* there is active systemic autoimmune disease;\n* patients with solitary extramedullary lesions;\n* research participants with a history of neurological diseases, such as epilepsy, intracranial hemorrhage, severe brain injury, cerebellar disease, memory impairment, spinal cord compression or any disease involving the central nervous system, or suspected active central nervous system (CNS) metastasis;\n* patients with bone marrow failure status related genetic syndromes: such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome were not excluded.\n* for patients who relapsed after treatment with drugs targeting CD19 and \u002F or CD20 before screening, the investigator judged that they could not benefit; 10. have received stem cell transplantation within 12 weeks before signing the informed consent; Received donor lymphocyte infusion (DLI) within 6 weeks;\n* received the following treatments before cell infusion:\n\n  1. Received anthracyclines, vinblastines, 6-mercaptopurine, 6-thioguanine, methotrexate, cytarabine, asparaginase, etc. within 7 days before infusion;\n  2. Hydroxyurea and tyrosine kinase inhibitors were used within 3 days before infusion;\n  3. Radiotherapy was used within 1 week before infusion (2 weeks interval for lung radiotherapy and 8 weeks interval for CNS radiotherapy);\n  4. CNS prophylactic therapy (such as intrathecal injection of chemotherapeutic drugs) within 1 week before infusion;\n  5. Give any T-cell lysis or antibody (such as alemtuzumab) within 8 weeks before infusion;\n  6. Use monoclonal antibody, double antibody or ADC within 4 weeks before infusion;\n  7. ;\n  8. Received systemic glucocorticoids equivalent to \\>15 mg\u002F day prednisone within 3 days before infusion, except for glucocorticoids used locally;\n  9. Polyethylene glycol asparaginase was used within 4 weeks before infusion;\n* have been vaccinated with live attenuated vaccine, inactivated vaccine or RNA vaccine within 4 weeks before signing the informed consent;\n* those who are allergic or intolerant to Qinglin drugs and tocilizumab, or allergic to components (dimethyl sulfoxide \u002Fdmso) in ct1190b cell infusion preparations; Or previous history of other serious allergies such as anaphylactic shock;\n* patients with any of the following cardiac diseases before screening:\n\n  1. New York Heart Association (NYHA) class III or IV heart failure;\n  2. ;\n  3. A history of clinically significant uncontrolled arrhythmias, such as ventricular arrhythmias;\n  4. A history of severe non ischemic cardiomyopathy;\n  5. Other heart diseases that the investigator believes may endanger the health of the patient due to participation in this clinical study;\n* serious lung disease may endanger the patient's life after participating in the study as judged by the investigator;\n* there are second primary malignant tumors that need treatment or have not been completely relieved in the past 2 years, except the following successfully treated tumors with low malignancy such as non metastatic basal cell carcinoma or squamous cell skin carcinoma, non metastatic prostate cancer, breast cancer or cervical cancer in situ, non muscle invasive bladder cancer or thyroid cancer;\n* major surgery within 2 weeks before signing the informed consent, or major surgery planned during the study or within 4 weeks after giving the study treatment (excluding cataract and other local anesthesia surgery);\n* after organ transplantation;","12 Years","75 Years",{"count":92,"type":20},18,[94],"EARLY_PHASE1","This study is a single arm, open label, dose exploring clinical trial to evaluate the safety, efficacy, cellular metabolic dynamics, and pharmacodynamics of ct1190b cells in relapsed \u002F refractory B-cell acute lymphoblastic leukemia.",[33],[33,98,37],"CT1190B","2026-03-12",{"date":101,"type":46},"2026-03-13",{"date":103,"type":20},"2026-04-01",{"date":105,"type":20},"2028-03-31",{"name":107,"class":81},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":82},"100615820","safety-and-feasibility-of-sulforaphane-to-promote-early-haematopoietic-recovery-after-cord-blood-transplantation-100615820","NCT07297576","Safety and Feasibility of Sulforaphane to Promote Early Haematopoietic Recovery After Cord Blood Transplantation","Safety and Feasibility of Sulforaphane to Promote Early Haematopoietic Recovery After Cord Blood Transplantation A Single-arm, Open, Single-centre Clinical Study","Inclusion criteria：\n\n1. Patients with high-risk haematological malignancies: including AML, ALL, high-risk MDS\n2. Age: ≥18 years\n3. Karnofsky score ≥70%, Eastern Cooperative Oncology Group (ECOG) physical status ≤2 points\n4. Selection of non-haematopoietic cord blood: donor-recipient HLA high-resolution compatibility ≥4\u002F6, 7\u002F10 and CD34 cells ≥0.83×105\u002Fkg (recipient's body weight), meeting the above criteria, only cord blood with a freezing time of ≥10 years can be found in China's public umbilical cord blood stem cell banks.\n\nExclusion criteria：\n\n1. Patients who test positive for the following pathogens: HIV (HIV-1\u002F2), human cytomegalovirus (HCMV-DNA), EBV (EBV-DNA), Hepatitis B (positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B DNA (HBV-DNA)), Hepatitis C Antibody (HCV-Ab), Treponema pallidum Antibody (TP-Ab).\n2. Active bacterial, viral, fungal or parasitic infections of clinical significance as judged by the investigator at the time of screening\n3. Willing donors with full HLA compatibility and eligible for allogeneic haematopoietic stem cell transplantation\n4. Previous gene therapy or allogeneic haematopoietic stem cell transplant recipients\n5. Immediate family members with known or suspected familial cancer syndromes (including but not limited to hereditary breast and ovarian cancer syndromes, hereditary non-polyposis colorectal cancer syndromes, familial adenomatous polyposis, etc.)\n6. Confirmed diagnosis of a major mental illness or predisposition to mental illness that would seriously affect the ability to participate in clinical research\n7. History of major organ injury, including: Liver lesions: liver function tests suggesting AST or ALT \\> 3 × ULN; total serum bilirubin \\> 2.5 × ULN; total bilirubin \\> 3 × ULN and direct bilirubin \\> 2.5 × ULN if consistent with Gilbert's syndrome; history of hepatic pontine fibrosis, cirrhosis, and the presence of active hepatitis; Cardiac lesions: left ventricular ejection fraction (\"LVEF\") \\\u003C 45%; New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 1 for classifications of heart failure); severe heart failure requiring treatment. Cardiac pathology: left ventricular ejection fraction (LVEF) \\\u003C45%; New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 1 for NYHA heart failure classification); severe arrhythmia requiring treatment; uncontrolled hypertension or unstable angina; myocardial infarction or bypass or stent surgery within 12 months prior to enrolment; clinically significant valvular disease; calculated eGFR \\\u003C60mL\u002Fmin\u002F1.73m2 and direct bilirubin \\>1.73m2; history of hepatic bridging fibrosis and cirrhosis; and presence of active hepatitis. Lung function: FEV1\u002FFVC \\\u003C60% and\u002For diffusion function \\\u003C60% of predicted value; clinically significant evidence of pulmonary hypertension requiring medical intervention.\n8. Uncorrectable coagulation disorders or history of severe bleeding disorders\n9. Any other condition that, in the opinion of the doctor, makes the subject unsuitable for haematopoietic stem cell transplantation\n10. Known allergy to the test drug or ingredients\n11. Have participated or are participating in other interventional clinical studies within 3 months prior to screening\n12. Live vaccination within 6 weeks prior to screening\n13. Pregnant or breastfeeding women\n14. Subjects did not follow the study protocol well\n15. Any other condition deemed by the investigator to be unsuitable for participation in this clinical trial",{"count":116,"type":20},36,[118],"NA","Umbilical cord blood (UCB) is rich in haematopoietic stem progenitor cells and immune cells, and is used for transplantation for a variety of haematological disorders with the advantages of low mating requirements and fewer transplant complications. By March 2025 China's seven (eight) public cord blood stem cell banks had frozen more than 280,000 public umbilical cord blood, while the percentage of those frozen for ≥10 years was 26%, making clinical application a concern. The previous study showed that long-term freezing impairs cellular mitochondrial function leading to decreased reconstruction of cord blood haematopoietic stem progenitor cells and impaired differentiation into the megakaryotic lineage, and that intervention with the antioxidant radicicol thiols (SFN) can partially rescue the cellular functional damage caused by freezing. The findings were based on immunodeficient animals, and clinical studies are urgently needed to determine whether SFN intervention can promote post-transplant haematopoietic reconstitution in patients with long term cryopreserved (≥10 years) UCB. In this project, the investigators propose to conduct a single-arm, open, single-centre phase I-II clinical study on the safety and feasibility of dietary supplement SFN to promote early haematopoietic restoration after cord blood transplantation to evaluate the safety and feasibility of the use of long-frozen UCB for peri-infusion SFN use in adult transplant recipients, and to reveal the effect of peri-infusion SFN use on neutrophil implantation. This project will provide scientific guidance to promote the clinical application of long-term cryopreserved UCB, as well as key data to optimise the clinical transplantation strategy of UCB and expand its application.",[33,121,122],"AML (Acute Myelogenous Leukemia","MDS (Myelodysplastic Syndrome)","2025-12-23",{"date":125,"type":46},"2025-12-30",{"date":127,"type":46},"2025-10-22",{"date":129,"type":20},"2027-06",{"name":131,"class":81},"Institute of Hematology & Blood Diseases Hospital, China",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":141,"conditions":142,"keywords":147,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":82},"100599696","ex-vivo-t-cell-depleted-haploidentical-transplantation-bridging-with-chimeric-antigen-receptor-t-cell-therapy-and-prophylactic-memory-t-cell-infusion-for-acute-leukemia-100599696","NCT07087847","Ex Vivo T-Cell-Depleted Haploidentical Transplantation Bridging With Chimeric Antigen Receptor T-cell Therapy and Prophylactic Memory T Cell Infusion for Acute Leukemia","Prospective, Single-Center, Single-Arm Clinical Study of Ex Vivo T-Cell-Depleted Haploidentical Transplantation Bridging With Chimeric Antigen Receptor T-cell Therapy and Prophylactic Memory T Cell Infusion for Acute Leukemia","Inclusion Criteria:\n\n* Diagnosis: Patients with refractory or relapsed (R\u002FR) leukemia.\n* Donor Availability: No matched sibling or unrelated donor identified through HLA typing.\n* Disease Status Post-CAR-T: including achieved complete remission (CR), minimal residual disease (MRD)-negative in bone marrow and no extramedullary relapse.\n* Normal Organ Function (meeting the following criteria): including liver function: ALT\u002FAST ≤10×ULN (upper limit of normal), total bilirubin (TBIL) ≤5×ULN, renal function: BUN and serum creatinine (Cr) ≤1.25×ULN and cardiac function: No evidence of cardiac insufficiency (confirmed by ECG and echocardiography).\n* Informed Consent: a signed informed consent form (ICF) is obtained\n\nExclusion Criteria:\n\n* Presence of any absolute contraindication to hematopoietic stem cell transplantation.\n* Severe Comorbidities with Major Organ Dysfunction",{"count":92,"type":20},[118],"CAR-T therapy has evolved as a pivotal treatment for relapsed\u002Frefractory (R\u002FR) leukemia, demonstrating improved remission rates and manageable adverse events. However, over 50% of patients achieving complete remission (CR) experience relapse within one year (1-year cumulative incidence rate, CIR) due to antigen escape, CAR-T functional exhaustion, premature cell depletion, and immunosuppressive microenvironments. Novel strategies are urgently needed to sustain durable responses.\n\nBridging CAR-T therapy with TCRαβ+ and CD45RA+ cell-depleted haploidentical hematopoietic stem cell transplantation (HSCT) offers dual benefits: Graft-versus-leukemia (GvL) effects mediated by donor-derived NK cells and γδT cells target non-CAR-dependent antigens, mitigating immune evasion. Rapid hematopoietic reconstitution reduces prolonged cytopenia-related complications from prior therapies. This protocol further incorporates prophylactic CD45RO+ memory T-cell (Tm) infusion to: Minimize graft-versus-host disease (GVHD) risks compared to conventional donor lymphocyte infusion (DLI). Enhance adoptive immunity against infections\u002Frelapse via transferred donor memory immunity. We design this prospective, single-center, single-arm trial to evaluate the efficacy\u002Fsafety of this approach using the CliniMACS® system for ex vivo TCRαβ+\u002FCD45RA+ depletion in R\u002FR leukemia patients post-CAR-T.",[143,144,145,33,146],"Acute Leukemia","Acute Leukemia Refractory","Acute Myeloid Leukemia (AML)","Acute Leukemia in Relapse",[148,149,150,151],"ex vivo t cell depletion","TCRab depletion","CD45RA depletion","memory T cell","NOT_YET_RECRUITING","2025-07-24",{"date":155,"type":46},"2025-07-28",{"date":157,"type":20},"2025-09-01",{"date":159,"type":20},"2028-09-30",{"name":161,"class":81},"Ruijin Hospital"]