[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Yongtai Ruike Biotechnology Company Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100529880","phase-2-car-t-19-injection-in-the-treatment-of-cd19-positive-relapsedrefractory-b-all-100529880",false,"NCT06179524","CAR-T-19 Injection in the Treatment of CD19-positive Relapsed\u002FRefractory B-ALL","Phase II Clinical Study of CAR-T-19 Injection in the Treatment of CD19-positive Relapsed\u002Frefractory B-cell Acute Lymphoblastic Leukemia(B-ALL) Under 25 Years of Age (inclusive)","Inclusion Criteria:\n\n1. Voluntary participation in clinical trial, The Participants or his legal guardian is fully understands this clinical trial and signs the Informed Consent Form (ICF); Willing to follow and be able to complete all trial procedures.\n2. Age≤25 years old at the time of screening, regardless of gender.\n3. Bone marrow examination confirmed the diagnosis of B-ALL, and meet one of the following conditions： Relapsed B-ALL：1）Relapse within 12 months of the first remission；2）Recurrence occurring again more than 12 months after the first remission,, relapsed or not responded after first-line\u002Fmulti-line salvage chemotherapy；3) Experienced two or more bone marrow recurrences; 4） recurrence after autologous or allogeneic hematopoietic stem cell transplantation； Refractory B-ALL：1）failed to achieve complete remission after 2 cycles of standard induction chemotherapy.\n4. Ph+ALL patients are eligible：1）Relapsed or refractory after receiving at least two Tyrosine kinase inhibitors (TKI) treatments；If Ph+ALL patients with t315i mutation are resistant to first- and second-generation TKIs, in the absence of effective TKI therapy, patients are not required to receive at least two TKIs；2）cannot tolerate TKI treatment；3）Presence of contraindications to TKI therapy.\n5. Bone marrow (BM) or peripheral blood (PB) tumor cells were measured to express CD19 at screening.\n6. Bone marrow blasts ≥ 5% at screening.\n7. Adequate organ function and must meet the following criteria： Alanine aminotransferase (ALT) ≤ 5 ×Upper limit of normal value(ULN)；Total serum bilirubin ≤ 2.0 ×ULN(（for Gilbert syndrome, total bilirubin≤3.0×ULN)；in non-oxygen state, No \\> grade 1 dyspnea, Blood oxygen saturation \\> 95%；left ventricular ejection fraction(LVEF) ≥ 50%；Serum creatinine≤1.5 × ULN；\n8. Karnofsky（age≥16 years）performance status≥70 or Lansky（age\\\u003C16 years）performance status≥50.\n9. Life expectancy ≥ 12 weeks.\n10. Adequate venous access (for apheresis) and no other contraindications to apheresis.\n11. Negative blood\u002Furine pregnancy test in women of childbearing potential before screening and within 3 days prior to cell infusion, and any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least 2 years after CAR-T-19 infusion. In the judgment of the investigator, a patient of childbearing potential means that he\u002Fshe is biologically capable of having children and having a normal sexual life.\n12. For Participants who have previously undergone allogeneic hematopoietic stem cell transplantation, CAR-T-19 cell preparation is performed using their previous donor peripheral blood， and the donor needs to meet the following conditions：1）Have donated bone marrow\u002Fhematopoietic stem cells as a transplant donor for the patient；2）Age ≥8 years at screening；3）Voluntary participation in clinical studies; the donor (and legal guardian, if applicable) am fully aware of and informed about this trial and have signed an informed consent form (ICF); Willing to follow and be able to complete all trial procedures；4）Have adequate venous access (for apheresis or venous blood collection) and no other contraindications to apheresis; 5) The etiological test results do not correspond to any of the exclusion criteria outlined in item 12. 6) Women of childbearing age have negative blood and urine pregnancy tests.7) Systemic glucocorticoid therapy is prohibited within one week prior to apheresis, with the exception of physiologically replacement doses of glucocorticoids (0.5 mg\u002Fkg\u002Fday of prednisone or equivalent doses of other corticosteroids).8) There are no cases of uncontrolled fungal, bacterial, viral, or other infections requiring intravenous treatment.\n\nExclusion Criteria:\n\n1. Isolated extra-medullary disease relapse .\n2. Participants with genetic syndromes, Patients with Down Syndrome will not be excluded.\n3. Participants with Burkitt's lymphoma\u002Fleukemia.\n4. Participants with active central nervous system disease.\n5. Active central nervous system leukemia at screening(Defined as CNS-3 and CNS-2 grades with neurological symptoms as defined by NCCN guidelines and judged by the investigator to be active central leukemia).\n6. Participants with a history of other malignant tumors or other malignant tumors at the same time (excluding fully treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, local prostate cancer after radical resection, thyroid cancer, ductal carcinoma in situ after radical resection).\n7. have or suspected to have fungal, bacterial, viral or other infections that are uncontrollable or require intravenous treatment.\n8. Participants who have received HSCT within 3 months before screening or Presence of grade 2 to 4 active graft-versus-host disease (GVHD), and those who have received systemic drug therapy for GVHD within 4 weeks before infusion.\n9. Received the following anti-tumor therapy before apheresis：1）Received any chemotherapy, targeted therapy, etc. within 4 weeks or at least 5 half-lives (whichever is shorter)；2）Radiotherapy within 14 days；3）Intrathecal treatment within 7 days；4) Received a donor lymphocyte transfusion (DLI) within 4 weeks; 5)Received Blinatumomab within 14 days.\n10. Participants who have been treated with systemic glucocorticoids within 1 week before apheresis, physiological replacement doses of steroids are allowed.\n11. Long-acting G-CSF is prohibited within 21 days and short-acting G-CSF is prohibited within 7 days before apheresis.\n12. Any of the following applies:1）Hepatitis B surface antigen (HBsAg) positive or HBV-DNA quantity is higher than the upper limit of normal value；2）Hepatitis C virus antibody (HCV Ab) is positive and HCV RNA quantification is higher than the upper limit of normal values;3）Positive for human immunodeficiency virus antibody (HIV-Ab);4）EB virus DNA quantification is higher than the upper limit of normal values;5）Cytomegalovirus DNA quantification is higher than the upper limit of normal values.\n13. Those who have received CAR-T therapy with any target.\n14. Allergy to albumin and aminoglycoside antibiotics.\n15. Received live vaccine within 6 weeks before screening.\n16. Participants after organ transplantation (except hematopoietic stem cell transplantation).\n17. participated in other interventional clinical studies (received active trial drug treatment) within 3 months before screening, or intend to participate in another clinical trial or receive another anti-tumor therapy.\n18. Other investigators deem it inappropriate to participate in the study.","ALL","25 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a phase II clinical study to evaluate the safety and efficacy of CAR-T-19 injection in the treatment of CD19-positive relapsed\u002Frefractory B-cell acute lymphoblastic leukemia.",[26,27],"Relapsed B-cell Acute Lymphoblastic Leukemia","Refractory B-cell Acute Lymphoblastic Leukemia","RECRUITING","2025-01-09",{"date":31,"type":32},"2025-01-13","ACTUAL",{"date":34,"type":32},"2024-01-03",{"date":36,"type":20},"2027-04-30",{"name":38,"class":39},"Beijing Yongtai Ruike Biotechnology Company Ltd","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":40},"100519718","phase-1-phase-i-clinical-trial-of-rc19d2-cell-injection-in-the-treatment-of-diffuse-large-b-cell-lymphoma-100519718","NCT06047197","Phase I Clinical Trial of RC19D2 Cell Injection in the Treatment of Diffuse Large B-cell Lymphoma","Phase I Clinical Trial of Dinorencel Injection (or RC19D2 Cell Injection) in the Treatment of CD19-positive Relapsed or Refractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Understand and voluntarily sign the informed consent form;\n* Age ≥ 18 years old at the time of screening, regardless of gender;\n* Patients with diffuse large B-cell lymphoma who have been diagnosed as CD19 positive by histopathology and\u002For cytology, but have failed standard treatment in the early stage, and currently lack effective treatment methods for recurrent or refractory CD19 positive.\n* The regulations for the past treatment status of research participants are as follows (meeting at least one of them): 1.At least after sufficient second-line treatment (CD20 positive individuals must have already used sufficient amounts of CD20 targeted drugs and anthracycline drugs), recurrence, no remission, or progression; In the first two lines of treatment, if the optimal therapeutic effect is SD, then the line of treatment must have completed 2 cycles;2.Recurrence, unrelieved, or progression after autologous hematopoietic stem cell transplantation;\n* According to the 2023 NCCN Lymphoma Treatment Guidelines and the 4th edition of the WHO Lymphatic Tissue Tumor Classification in 2016, the following types were included in this trial:Diffuse large B-cell lymphoma (DLBCL) non-specific (DLBCL-NOS)；Transforming follicular lymphoma (tFL)；High grade B-cell lymphoma (HGBL) with MYC, BCL2, and\u002For BCL6 rearrangement；High grade B-cell lymphoma, non-specific (HGBL-NOS)；Primary mediastinal large B-cell lymphoma (PMBL)；Grade 3b follicular lymphoma (FL3b);\n* Expected survival time ≥ 12 weeks;\n* There are measurable target lesions in imaging: the length and diameter of lesions in lymph nodes ≥ 15mm, or extranodal lesions\\>10mm (according to Lugano2014 standard); Lesions that have received radiotherapy in the past are considered measurable only when there is clear progress after completing radiotherapy;\n* During screening, laboratory inspections must meet the following requirements:Neutrophil count ≥ 1.0 × 10\\^9\u002FL;Lymphocyte count ≥ 0.3 × 10\\^9\u002FL; Hemoglobin ≥ 70 g\u002FL;Platelets ≥ 50 × 10\\^9\u002FL;Total serum bilirubin ≤ 2.0 × Upper limit of normal value (ULN);Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;Creatinine\\\u003C1.5 × ULN and endogenous creatinine clearance rate ≥ 60 mL\u002Fmin (creatinine clearance rate Cockcroft Fault method: male creatinine clearance rate=\\[(140 age) × Weight (kg)\\]\u002F\\[0.818 × Creatinine（ μ Mol\u002FL)\\]; Female creatinine clearance rate=\\[(140 age) × Body weight (kg) × 0.85\\]\u002F\\[0.818 × Creatinine（ μ Mol\u002FL)\\].\n* The lung function is good, and the blood oxygen saturation of the fingertip pulse under non oxygen inhalation is ≥ 92%;\n* The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0 or 1;\n* Head MRI shows no central nervous system lymphoma;\n* Cardiac ultrasound shows left ventricular ejection fraction ≥ 50%; No clinically significant abnormal electrocardiogram findings; No clinically significant pericardial or pleural effusion;\n* Adequate venous access (for single collection) and no other contraindications for blood cell separation;\n* The screening period blood pregnancy test for female participants of childbearing age must be negative\n\nExclusion Criteria:\n\n* Individuals with a history of allergies to any component in cellular products;\n* Individuals with a history of allogeneic hematopoietic stem cell transplantation;\n* Individuals with a history of organ transplantation;\n* hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and\u002For hepatitis B core antibody (HBc Ab) are positive, and the HBV-DNA quantity is higher than the upper limit of normal value; Hepatitis C virus antibody (HCV Ab) is positive and HCV RNA quantification is higher than the upper limit of normal values; Positive for human immunodeficiency virus antibody (HIV-Ab); Positive anti Treponema pallidum antibody (TP Ab); Cytomegalovirus DNA quantification is higher than the upper limit of normal values; EB virus DNA quantification is higher than the upper limit of normal values;\n* CNS diseases that have clinical significance in the past or screening, such as epilepsy, epileptic seizures, paralysis, aphasia, cerebral vascular ischemia\u002Fbleeding, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, mental illness, etc;\n* Patients with active primary or secondary central nervous system (CNS) lymphoma (patients with CNS disease symptoms must undergo lumbar puncture examination to rule out CNS lymphoma).\n* Those who have previously received other genetically modified T cell therapies, or other CAR-T therapies, or any other targeted therapy against CD19;\n* Having severe genetic or autoimmune diseases (such as systemic lupus erythematosus);\n* Screening for thromboembolic events within the first 6 months (such as myocardial infarction, pulmonary infarction, deep vein thrombosis, and other systemic thrombotic diseases);\n* Screening for malignant tumors other than those indicated in this study within the first 5 years, except for tumors in situ (such as cervical cancer, bladder, breast cancer) or non melanoma skin cancer;\n* Active or uncontrollable infections that require systemic treatment;\n* Within 9 months prior to PBMC collection, received treatment with Bendamustine、Alenzumab, Fludarabine,and Cladribine;;\n* Within 4 weeks prior to PBMC collection, patients received naloxamine, calcineurin inhibitors, chemotherapy drugs (methotrexate, cyclophosphamide, ifosfamide, benzoate nitrogen mustard or mefalam,), mycophenolate, thalidomide, immunosuppressive antibodies such as anti TNF, anti IL6, or anti IL6R therapy, tumor radiotherapy, or drugs that can bind to FKBP 12 protein (such as rapamycin, tacrolimus, everolimus, etc.);\n* Long acting cell growth factors (such as polyethylene glycol recombinant human granulocyte stimulating factor PEG-rhG-CSF) were used within 3 weeks prior to PBMC collection;\n* Received granulocyte macrophage colony stimulating factor (GM-CSF) treatment within 2 weeks prior to PBMC collection;\n* Individuals who have received short-term cell growth factors (such as recombinant human granulocyte colony-stimulating factor, recombinant human thrombopoietin, etc.), hematopoiesis agonists\u002Fstimulators (such as haitrapopa ethanolamine tablets), CD20 monoclonal antibodies, and corticosteroids within 7 days prior to PBMC collection (excluding those who have received inhaled, local steroid therapy, and physiological replacement therapy for adrenal insufficiency);\n* Received platelet transfusion within 7 days before the screening period;\n* Pregnant or lactating women, or men or women with fertility potential, refuse to use contraception during the trial period and at the end of the trial (2 years after RC19D2 cell reinfusion);\n* Patients who have participated in other drug clinical trials within 4 weeks prior to PBMC collection (new drug clinical trials, registered studies, clinical studies initiated by researchers, etc.);\n* The researcher believes that this clinical trial is not suitable (such as poor compliance, drug abuse, etc.);\n* Those who have received live or attenuated vaccines within 3 months prior to PBMC collection, or are expected to need to receive such vaccines during this trial.","18 Years",{"count":50,"type":20},25,[52],"PHASE1","This trial is a phase I clinical trial aimed at the safety and tolerability of RC19D2 cell injection in the treatment of CD19 positive patients with recurrent or refractory diffuse large B-cell lymphoma",[55,56],"Recurrent Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-cell Lymphoma",[58,59,60,61],"CD19","CAR-T","RC19D2","DLBCL","2024-08-25",{"date":64,"type":32},"2024-08-27",{"date":66,"type":32},"2023-09-05",{"date":68,"type":20},"2026-12-05",{"name":38,"class":39},""]