[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangdong Ruishun Biotech Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":118},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,68,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100584848","phase-1-a-phase-i-clinical-trial-of-rs001-in-patients-with-relapsedrefractory-b-cell-malignancies-100584848",false,"NCT06894693","A Phase I Clinical Trial of RS001 in Patients with Relapsed\u002FRefractory B-Cell Malignancies","A Phase I Clinical Trial of RS001 in Patients with Relapsed\u002FRefractory B-Cell Malignancies:","Inclusion Criteria:\n\n1. Voluntarily sign an ICF and expect to complete the subsequent follow-up.\n2. Aged 18 to 75 years (including cut-offs), regardless of gender.\n3. Meet one of the following B-cell malignancies:\n\n\u003C!-- -->\n\n1. . B-cell non-Hodgkin's lymphoma diagnosed as CD19-positive by cytology or histopathology according to WHO 2022 criteria, including pathologically confirmed (1) diffuse large B-cell lymphoma, non-specific type (DLBCL, NOS); (2) follicular lymphoma histopathologically graded as grade 3b (FL3b); (3) follicular lymphoma with diffuse large B-cell transformation; (4) primary mediastinal large B-cell lymphoma (PMBCL); (5) high-grade B-cell lymphoma (HGBCL).\n\n   1. Relapsed\u002Frefractory B-cell non-Hodgkin lymphoma, defined as meeting one or more of the following criteria:\n\n      \\- Definition of relapse: Relapse after achieving remission (PR and CR) with second-line or higher therapy;\n      * Definition of refractory: No response to second-line or more therapy: The best efficacy of last therapy is PD or SD (SD requires at least 2 cycles of treatment); Recurrence (must have biopsy-proven recurrence) or progression within 12 months of autologous stem cell transplantation (ASCT) . If salvage therapy, no response to last therapy (SD or PD).\n   2. Subjects must have received adequate treatment in the past, which should include the following treatments:\n\n      * Anti-CD20 monoclonal antibody, unless the investigator determines that the tumor is CD20 negative;\n      * Chemotherapy containing anthracycline drugs;\n      * For subjects with transformed follicular lymphoma (tFL) who have been previously treated with follicular lymphoma (FL) chemotherapy and with transformation to DLBCL show refractory to chemotherapy.\n   3. ECOG performance status 0 to 1.\n   4. The presence of a measurable lesion that meets one of the following criteria:\n\n      * The long axis of the lymph node lesion exceeds 15 mm in length (the short axis is measurable);\n      * The long and short axes of the extralymph node lesion exceed 10 mm in length.\n2. Relapsed\u002Frefractory B-cell acute lymphoblastic leukemia must meet the following requirements:\n\n   1. Relapsed: Recurrence within 12 months after the first remission;\n   2. Refractory: i. failure to remit after more than 6 weeks of induction therapy or failure to remit after two courses of induction therapy; ii. relapse after 2 or more CRs; iii. first relapse after chemotherapy and failure to remit after having received at least 1 salvage therapy; iv. relapse after autologous hematopoietic stem cell transplantation;\n   3. Prior to screening, leukemia cells expressing CD19 are detectable in bone marrow or peripheral blood.\n   4. Ph+ ALL patients who have failed treatment with at least 2 tyrosine kinase inhibitor (TKI) drugs (including at least 1 2nd generation TKI drug) or are intolerant of drug-related side effects such as allergy to components of the TKI class of drugs, blood abnormalities, liver or kidney impairment, severe cardiovascular toxicity, and other drug-related side effects that prevent them from continuing to be a user; If the patient has the T315I mutation, TKI salvage therapy is not required;\n   5. The proportion of primitive and naïve lymphocytes in bone marrow during the screening period ≥5%; 4. Laboratory results within 7 days prior to Lymphodepletion need to meet the following criteria:\n\n   \u003C!-- -->\n\n   1. Coagulation function:\n\n      \\- Activated partial thromboplastin time ≤ 1.5 times the upper limit of normal (ULN);\n\n      \\- Prothrombin time (PT) ≤ 1.5 times ULN;\n   2. Liver function:\n\n      \\- Glutathione aminotransferase (AST) ≤ 5 times the upper limit of normal (ULN);\n\n      \\- Total bilirubin ≤ 1.5 times ULN, unless the subject has documented Gilbert syndrome;\n\n      \\- Subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included.\n   3. Renal function: Serum creatinine ≤ 1.5 times ULN or a creatinine clearance ≥ 60 ml\u002Fmin;\n   4. Complete blood count (No blood transfusion treatment received within 7 days prior to examination):\n\n      \\- Haemoglobin ≥ 80 g\u002FL;\n\n      \\- Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL;\n      * A platelet count ≥ 50 x 10\\^9\u002FL;\n   5. Cardiopulmonary function:\n\n      * Left ventricular ejection fraction (LVEF) ≥ 45%;\n      * Oxygen saturation ≥ 91%; 5. Female subjects with of childbearing potential should have a negative pregnancy test during the screening period. Any male and female subjects of childbearing potential must agree to use an effective contraception method for at least six months from the time that they sign the informed consent form until the end of the cell infusion. Female subjects without childbearing potential (meeting at least 1 of the following criteria) is described below:\n\n   a. Have undergone a hysterectomy or bilateral oophorectomy; b. Medically recognised ovarian failure; c. Medically recognised as post-menopausal (at least 12 consecutive months of menopause without pathological or physiological cause).\n\nExclusion Criteria:\n\n1. Other malignancies within 5 years prior to screening, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, post-radical localized prostate cancer, post-radical ductal carcinoma in situ, and post-radical thyroid cancer;\n2. Any unstable systemic disease: including but not limited to active infection (other than local infection), unstable angina, cerebrovascular accident or transient ischaemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (refractory hypertension is defined as blood pressure that has not reached standard after \\>1 month of reasonably tolerable treatment with ≥3 antihypertensive drugs (including diuretics) at adequate doses based on lifestyle improvement or blood pressure that is not effectively controlled with ≥4 antihypertensive drugs), severe cardiac arrhythmias requiring pharmacologic treatment, hepatic arrhythmias, liver diseases, kidney diseases or metabolic disorders;\n3. Patients with B-cell non-Hodgkin's lymphoma with active central nervous system invasion.\n4. Patients with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titres not within the normal reference range, positive hepatitis C virus (HCV) antibody and peripheral blood HCV RNA ,positive for human immunodeficiency virus (HIV), or positive for cytomegalovirus (CMV) DNA, or positive syphilis test.\n5. Subjects who are receiving systemic steroids prior to screening and who are judged by the investigator to require long-term treatment with systemic steroids during the treatment period (except for inhaled or topical use).\n6. Previous organ transplantation or preparation for organ transplantation (except for haematopoietic stem cell transplantation).\n7. Persons with acute\u002Fchronic Graft-vs-Host Disease (GvHD).\n8. Patients have received a haematopoietic stem cell transplant within 2 months prior to screening.\n9. Patients who have previously received any CD19-CAR-T\u002FNK cell therapy, or received CAR-T\u002FNK cell therapy targeting other antigens within the three months prior to screening.\n10. Active neurological autoimmune or inflammatory diseases (e.g. Guillain-Barre Syndrome (GBS), Amyotrophic lateral sclerosis (ALS)).\n11. Clinically significant active cerebrovascular diseases (such as cerebral edema, posterior reversible encephalopathy syndrome).\n12. Patients with a life expectancy of less than 3 months.\n13. Participants who have previously been involved in other interventional clinical studies and received active investigational drugs, with the last use of an unapproved new drug being less than 28 days prior to signing the informed consent for this trial, or the last use of an approved drug being less than five half-lives prior to cell infusion.\n14. Received attenuated live vaccine within 6 weeks prior to lymphodepletion.\n15. The subjects have contraindications or hypersensitivity reactions to fludarabine, cyclophosphamide, tocilizumab, investigational product and its ingredients.\n16. Remaining within the washout period of other antitumor treatments prior to lymphodepletion.\n17. Patients who, in the investigator's judgment and\u002For clinical criteria, have a contraindication to any of the study procedures or have other medical conditions that may place them at unacceptable risk.","ALL","18 Years","75 Years",{"count":20,"type":21},13,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is an open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic profile in the body after infusion of RS001 injection, and preliminary efficacy in subjects with CD19-positive relapsed\u002Frefractory B-cell malignancies (BCM).",[27,28],"B-cell Non-Hodgkin's Lymphoma","Acute Lymphoblastic Leukemia","NOT_YET_RECRUITING","2025-03-18",{"date":32,"type":33},"2025-03-25","ACTUAL",{"date":35,"type":21},"2025-04-01",{"date":37,"type":21},"2028-04-01",{"name":39,"class":40},"Guangdong Ruishun Biotech Co., Ltd","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":5},"100542255","phase-1-a-study-of-rjmty19-in-refractory-systemic-lupus-erythematosus-sle-100542255","NCT06340490","A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE)","A Phase I Clinical Trial of RJMty19 in Treatment of Subjects With Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Voluntarily sign an ICF and expect to complete the subsequent follow-up.\n2. Age 18～65 years old (including cut-off value), gender is not limited.\n3. Diagnosed with SLE according to the 2019 EULAR\u002FACR version of the revised criteria.\n4. Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 points; Anti-nuclear antibody titer ANA≥1:80, or positive anti-dsDNA and\u002For anti-Sm antibodies.\n5. Presence of active organ involvement.\n6. Having appropriate organ function, and the laboratory test results within 7 days before the lymphodepletion must meet the following criteria:\n\n   1. Coagulation function:\n\n      * Fibrinogen ≥1.0 g\u002FL;\n      * Activated partial thromboplastin time ≤ 1.5 times the upper limit of normal (ULN);\n      * Prothrombin time (PT) ≤ 1.5 times ULN.\n   2. Liver function:\n\n      * Glutathione aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN);\n      * Glutamic aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN);\n      * Total bilirubin ≤ 1.5 times ULN, unless the subject has documented Gilbert syndrome;\n      * Subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included.\n   3. Renal function:\n\n      * Serum creatinine ≤ 1.5 times ULN or a creatinine clearance ≥ 60 ml\u002Fmin;\n   4. Complete blood count:\n\n      * Haemoglobin ≥ 80 g\u002FL;\n      * Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL;\n      * Platelet count ≥ 50 x 10\\^9\u002FL;\n   5. Cardiopulmonary function:\n\n      * Left ventricular ejection fraction (LVEF) ≥ 45%;\n      * Oxygen saturation ≥ 91%\n7. Female patients with of childbearing potential should have a negative pregnancy test during the screening period. Any male and female patients of childbearing potential must agree to use an effective contraception method for at least six months from the time that they sign the informed consent form until the end of the cell infusion. Female subjects with non-childbearing potential (meeting at least 1 of the following criteria) is described below:\n\n   1. Have undergone a hysterectomy or bilateral oophorectomy;\n   2. Medically recognised ovarian failure;\n   3. Medically recognised as post-menopausal (at least 12 consecutive months of menopause without pathological or physiological cause).\n8. Use of hormones and at least two standard immunosuppressants and at least one biological agent for more than six months without meeting the LLDAS criteria; or allergy, intolerance and other drug-related side effects to the components of the biological agent make it impossible for the user to continue;\n9. Life expectancy greater than 6 months;\n10. Confirmed presence of CD19 positive B cells in peripheral blood by flow cytometry.\n\nExclusion Criteria:\n\n1. Other malignancies within 5 years prior to screening, except adequately treated non-melanoma skin cancer (basal cell carcinoma or squamous cell carcinoma) or carcinoma in situ of the cervix;\n2. Major surgery requiring hospitalization within 4 weeks prior to screening or during screening;\n3. History of severe drug allergies or anaphylactic constitution;\n4. Renal disease: Diagnosed with active severe lupus nephritis within 8 weeks prior to screening, requiring treatment with drugs prohibited by the study protocol for the treatment of active nephritis, hemodialysis or prednisone dose ≥ 100 mg\u002Fd, or equivalent glucocorticoids for ≥14 days; Creatinine clearance rate \\\u003C 60mL\u002Fmin and serum creatinine \\> 1.5 times ULN within 1 week before lymphodepleting chemotherapy;\n5. Central nervous system diseases: those with active central nervous system diseases caused by SLE or non-SLE (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis);\n6. Cardiovascular disease: unstable angina, myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (The definition of refractory hypertension is: on the basis of improving lifestyle, reasonable and tolerable use of ≥3 antihypertensive drugs (including diuretics) for more than 1 month, blood pressure still not reached the target (systolic blood pressure≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg) or taking ≥4 antihypertensive drugs to effectively control blood pressure) and a history of severe arrhythmias requiring medication;\n7. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer test higher than the lower limit of the detection value, hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive, human immunodeficiency virus (HIV) antibody positive, cytomegalovirus (CMV) DNA test positive, syphilis test positive;\n8. Presence of active or uncontrollable infection requiring systemic treatment (other than simple urinary tract infection or upper respiratory tract infection) and currently receiving suppressive therapy for any chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria); untreated latent tuberculosis infection;\n9. There is clinical evidence showing the presence of important, unstable, or uncontrolled acute or chronic diseases not caused by SLE (i.e. cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignant tumors, or infectious diseases), which researchers believe may confound the study results or expose subjects to unnecessary risks;\n10. Vaccination with live or attenuated live vaccine within 1 month before screening;\n11. History of\u002Fpreparing to undergo organ transplantation or hematopoietic stem cell transplantation;\n12. Received CAR-T therapy or other gene-modified cell therapy prior to enrolment;\n13. Have received any of the following treatments for SLE:\n\n    1. Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent\\> 20 mg\u002Fd) within 72 hours prior to lymphodepleting chemotherapy or RJMty19 infusion;\n    2. Treatment of SLE with any other clinical investigational agent within 4 weeks prior to enrollment. However, enrollment is allowed if the study treatment period is ineffective or the disease has progressed, and at least 3 half-lives have elapsed prior to enrollment;\n    3. Received belimumab within 8 weeks and anti-CD20 monoclonal antibody (e.g., rituximab) within 6 months prior to screening;\n    4. Blood transfusion, packed red blood cells, and platelet transfusion within 6 weeks prior to enrollment;\n    5. Plasmapheresis and plasmapheresis were treated within 3 months prior to enrollment;\n14. Congenital immunoglobulin deficiency;\n15. Participated in other clinical studies within the previous 3 months, except for clinical studies that have been evaluated by the investigator as not interfering with the safety and efficacy of the study drug, such as non-intervention observational studies;\n16. In the judgment of the investigator and\u002For clinical criteria, there are contraindications to any of the study procedures or other medical conditions that may expose to unacceptable risks;\n17. Presence of other autoimmune diseases that may interfere with the evaluation of efficacy (including but not limited to: rheumatoid arthritis, spondyloarthritis, dermatomyositis\u002Fpolymyositis, systemic sclerosis, mixed connective tissue disease, etc.).","65 Years",{"count":50,"type":21},24,[24],"This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects.",[54],"Systemic Lupus Erythematosus",[56,57,58,59],"off-the-shelf cell product","CAR-DNT","Cell Therapy","Autoimmune Disease","2024-03-25",{"date":62,"type":33},"2024-04-01",{"date":64,"type":21},"2024-05-15",{"date":66,"type":21},"2027-12-31",{"name":39,"class":40},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100540283","phase-1-a-tolerability-safety-and-efficacy-study-of-rjmty19-in-subjects-with-relapsed-or-refractory-b-nhl-100540283","NCT06314828","A Tolerability, Safety and Efficacy Study of RJMty19 in Subjects With Relapsed or Refractory B-NHL","A Phase 1, Open-label, Single Arm Clinical Trial to Evaluate the Tolerability, Safety and Efficacy of RJMty19 in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)","Inclusion Criteria:\n\n1. Voluntarily sign an ICF and expect to complete the subsequent follow-up.\n2. Aged 18 to 65 years (including cut-offs), regardless of gender.\n3. B-cell non-Hodgkin's lymphoma diagnosed as CD19-positive by cytology or histopathology according to WHO 2022 criteria, including pathologically confirmed (1) diffuse large B-cell lymphoma, non-specific type (DLBCL, NOS); (2) follicular lymphoma histopathologically graded as grade 3b (FL3b); (3) follicular lymphoma with diffuse large B-cell transformation; (4) primary mediastinal large B-cell lymphoma (PMBCL); (5) high-grade B-cell lymphoma (HGBCL).\n4. Relapsed\u002Frefractory B-cell non-Hodgkin's lymphoma, provided one of the following conditions is met:\n\n   1. Definition of relapse: Relapse after achieving remission (PR and CR) with second-line or higher therapy;\n   2. Definition of refractory:\n\n      * No response to second-line or more therapy: The best efficacy of last therapy is PD or SD (SD requires at least 2 cycles of treatment);\n      * Recurrence (must have biopsy-proven recurrence) or progression within 12 months of autologous stem cell transplantation (ASCT) . If salvage therapy, no response to last therapy (SD or PD).\n5. Subjects must have received adequate treatment in the past, which should include the following treatments:\n\n   1. Anti-CD20 monoclonal antibody, unless the investigator determines that the tumor is CD20 negative;\n   2. Chemotherapy containing anthracycline drugs;\n   3. For subjects with transformed follicular lymphoma (tFL) who have been previously treated with follicular lymphoma (FL) chemotherapy and with transformation to DLBCL show refractory to chemotherapy.\n6. ECOG performance status 0 to 1.\n7. The presence of a measurable lesion that meets one of the following criteria:\n\n   1. The long axis of the lymph node lesion exceeds 15 mm in length (the short axis is measurable);\n   2. The long and short axes of the extralymph node lesion exceed 10 mm in length.\n8. ALaboratory results within 7 days prior to Lymphodepletion need to meet the following criteria:\n\n   1. Coagulation function:\n\n      * Activated partial thromboplastin time ≤ 1.5 times the upper limit of normal (ULN);\n      * Prothrombin time (PT) ≤ 1.5 times ULN;\n   2. Liver function:\n\n      * Glutathione aminotransferase (AST) ≤ 5 times the upper limit of normal (ULN);\n      * Glutamic aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN);\n      * Total bilirubin ≤ 1.5 times ULN, unless the subject has documented Gilbert syndrome;\n      * Subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included.\n   3. Renal function:\n\n      * Serum creatinine ≤ 1.5 times ULN or a creatinine clearance ≥ 60 ml\u002Fmin;\n   4. Complete blood count (No blood transfusion treatment received within 7 days prior to examination):\n\n      * Haemoglobin ≥ 80 g\u002FL;\n      * Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL;\n      * A platelet count ≥ 50 x 10\\^9\u002FL;\n   5. Cardiopulmonary function:\n\n      * Left ventricular ejection fraction (LVEF) ≥ 45%;\n      * Oxygen saturation ≥ 91%;\n9. Female subjects with of childbearing potential should have a negative pregnancy test during the screening period. Any male and female subjects of childbearing potential must agree to use an effective contraception method for at least six months from the time that they sign the informed consent form until the end of the cell infusion. Female subjects without childbearing potential (meeting at least 1 of the following criteria) is described below:\n\n   1. Have undergone a hysterectomy or bilateral oophorectomy;\n   2. Medically recognised ovarian failure;\n   3. Medically recognised as post-menopausal (at least 12 consecutive months of menopause without pathological or physiological cause).\n\nExclusion Criteria:\n\n1. Other malignancies within 5 years prior to screening, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, post-radical localized prostate cancer, post-radical ductal carcinoma in situ, and post-radical thyroid cancer\n2. Any unstable systemic disease: including but not limited to active infection (other than local infection), unstable angina, cerebrovascular accident or transient ischaemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (refractory hypertension is defined as blood pressure that has not reached standard after \\>1 month of reasonably tolerable treatment with ≥3 antihypertensive drugs (including diuretics) at adequate doses based on lifestyle improvement or blood pressure that is not effectively controlled with ≥4 antihypertensive drugs), severe cardiac arrhythmias requiring pharmacologic treatment, hepatic arrhythmias, liver diseases, kidney diseases or metabolic disorders.\n3. Patients with B-cell non-Hodgkin's lymphoma with active central nervous system invasion.\n4. Patients with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titres not within the normal reference range, positive hepatitis C virus (HCV) antibody and peripheral blood HCV RNA ,positive for human immunodeficiency virus (HIV), or positive for cytomegalovirus (CMV) DNA, or positive syphilis test.\n5. Subjects who are receiving systemic steroids prior to screening and who are judged by the investigator to require long-term treatment with systemic steroids during the treatment period (except for inhaled or topical use).\n6. Previous organ transplantation or preparation for organ transplantation (except for haematopoietic stem cell transplantation).\n7. Persons with acute\u002Fchronic Graft-vs-Host Disease (GvHD).\n8. Patients have received a haematopoietic stem cell transplant within 2 months prior to screening.\n9. Active neurological autoimmune or inflammatory diseases (e.g. Guillain-Barre Syndrome (GBS), Amyotrophic lateral sclerosis (ALS)).\n10. Clinically significant active cerebrovascular diseases (such as cerebral edema, posterior reversible encephalopathy syndrome).\n11. Patients with a life expectancy of less than 3 months.\n12. Subjects have participated in other interventional clinical studies within 3 months prior to screening.\n13. Received attenuated live vaccine within 6 weeks prior to lymphodepletion.\n14. The subjects have contraindications or hypersensitivity reactions to fludarabine, cyclophosphamide, etoposide, tocilizumab, investigational product and its ingredients.\n15. Remaining within the washout period of other antitumor treatments prior to lymphodepletion.\n16. Patients who, in the investigator's judgment and\u002For clinical criteria, have a contraindication to any of the study procedures or have other medical conditions that may place them at unacceptable risk.",{"count":76,"type":21},30,[24],"This is a Phase 1, open-label, single-arm study to evaluate tolerability, safety and efficacy of RJMty19 in adult subjects with r\u002Fr B-NHL.",[27],[56,57,58,81],"B-NHL","2024-03-11",{"date":84,"type":33},"2024-03-18",{"date":86,"type":21},"2024-05-20",{"date":88,"type":21},"2027-05-20",{"name":39,"class":40},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100505242","phase-1-rc1012-injection-allo-dnt-cells-for-the-prevention-of-relapse-in-aml-patients-after-allo-hsct-100505242","NCT05858814","RC1012 Injection (Allo-DNT Cells) for the Prevention of Relapse in AML Patients After Allo-HSCT","A Phase I\u002FII Clinical Trial of RC1012 Injection for the Prevention of Relapse in AML Patients After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Voluntarily sign an ICF and expect to complete the study procedures for follow-up examinations and treatment.\n2. Aged 18 to 70 years (including cut-offs), regardless of gender.\n3. Subject must be diagnosed with AML according to World Health Organization (WHO) criteria (2016).\n4. The subject has received an allogeneic HSCT within 60-100 days, the percentage of malignant primitive cells in the bone marrow is \\\u003C 5% after HSCT and STR-PCR shows complete donor chimerism.\n5. The subject has one of the following high-risk factors for relapse after allo-HSCT: (1) Failure to achieve remission after two courses of induction chemotherapy. (2) Prior history of Myelodysplastic Syndromes (MDS) or Myeloproliferative Neoplasm (MPN). (3) High leukocytes (≥100×10\\^9\u002FL) combined with Central Nervous System Leukemia (CNSL); (4) Positive Minimal Residual Disease (MRD) before HSCT; (5) Non-remission or disease progression prior to HSCT; (6) Subject with cytogenetic high-risk factors (except that who can be treated with targeted drugs).\n6. The subject has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade \\\u003C2 (unless the abnormality is tumor-related).\n7. ECOG score 0 to 1.\n8. With appropriate organ function:\n\n   * Glutathione aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN);\n   * Glutamic aminotransferase (ALT) ≤ 3 times ULN;\n   * Total bilirubin ≤ 1.5 times ULN, unless the patient has documented Gilbert syndrome. Patients with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included;\n   * Serum creatinine ≤ 1.5 times ULN or a creatinine clearance ≥ 60 ml\u002Fmin;\n   * Hemoglobin ≥ 80 g\u002FL or hemoglobin maintained at that level following transfusion;\n   * International Normalized Ratio (INR) ≤ 1.5 times ULN and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN;\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL.\n   * A platelet count ≥ 50 x 10\\^9\u002FL or a platelet count maintained at that level following a platelet transfusion;\n   * Left ventricular ejection fraction (LVEF) ≥ 45%.\n9. Female patients with childbearing potential should have a negative pregnancy test during the screening period. Any male and female patients of childbearing potential must agree to use an effective contraception method for at least six months from the time that they sign the informed consent form until the end of the cell infusion. Female patients without childbearing potential (meeting at least 1 of the following criteria) is described below.\n\n   * Have undergone a hysterectomy or bilateral oophorectomy;\n   * Medically recognized as ovarian failure;\n   * Medically recognized as post-menopausal (at least 12 consecutive months of menopause without pathological or physiological cause).\n\nExclusion Criteria:\n\n1. Subject is confirmed to have morphological relapse of leukemia or positive MRD after allo-HSCT.\n2. Subject with extramedullary infiltration of leukemia.\n3. Suffer from other malignancies within 5 years prior to screening, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, post-radical thyroid cancer, and post-radical ductal carcinoma in situ.\n4. Has severe respiratory disease (previous or combined history of severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm).\n5. A previous history of a definite neurological or psychiatric disorder, including epilepsy or dementia.\n6. Evidence of active central nervous system invasion or cranial neuropathy.\n7. Patients with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titration assay not within the normal reference range, positive hepatitis C virus (HCV) antibody and peripheral blood HCV RNA ,positive for human immunodeficiency virus (HIV), or positive for cytomegalovirus (CMV) DNA, or positive syphilis test.\n8. Subject who is allergic to the excipients of RC1012 injection or other drugs recommended in the study protocol (e.g., tolimumab, etc.).\n9. Serious cardiac disease, including but not limited to severe arrhythmia, unstable angina, massive heart attack, New York Heart Association class III or IV cardiac insufficiency, refractory hypertension.\n10. Persons who have previously received an organ transplant or are preparing to receive an organ transplant (except for HSCT).\n11. Subject who has received other maintenance therapy drugs after HSCT or who wish to receive other maintenance therapy.\n12. Subject with the presence of acute GvHD of degree III to IV or extensive chronic GvHD.\n13. Active neurological autoimmune or inflammatory diseases (e.g. Guillain-Barre Syndrome (GBS), Amyotrophic lateral sclerosis (ALS)).\n14. Clinically significant active cerebrovascular disease (e.g. cerebral oedema, Posterior Reversible Encephalopathy Syndrome (PRES)).\n15. Subject with a life expectancy of less than 3 months.\n16. Subject has been involved in other clinical studies within 3 months prior to screening.\n17. Subject , in the judgement of the investigator and\u002For clinical criteria, is contraindicated to any study procedure or have other medical conditions that may place them at unacceptable risk.","70 Years",{"count":99,"type":21},72,[24,101],"PHASE2","To evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT",[104],"Acute Myeloid Leukemia",[106,58,107,56],"allo-HSCT","AML","RECRUITING","2023-05-17",{"date":111,"type":33},"2023-05-19",{"date":113,"type":33},"2023-05-04",{"date":115,"type":21},"2026-06-24",{"name":39,"class":40},1,""]