[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nanjing Miracle Biotechnology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,61],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100655437","clinical-study-of-cht105-injection-in-the-treatment-of-relapsedrefractory-autoimmune-diseases-100655437",false,"NCT07811622","Clinical Study of CHT105 Injection in the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","An Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Cell Injection Targeting CD19\u002FCD70 (CHT105) in Patients With Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age ≥18 and ≤65 years (inclusive), no restriction on gender;\n2. Positive expression of CD19\u002FCD70 on peripheral blood B-cells as determined by flow cytometry;\n3. Key organ functions shall meet the following requirements:\n\n1). Bone marrow function: a. Absolute neutrophil count ≥1×10⁹\u002FL (no colony-stimulating factor therapy within 2 weeks prior to testing, except for neutropenia caused by underlying disease); b. Hemoglobin ≥60 g\u002FL; 2). Liver function: ALT ≤3×ULN (except for ALT elevation due to underlying disease); AST ≤3×ULN (except for AST elevation due to underlying disease); TBIL ≤1.5×ULN (except for TBIL elevation due to underlying disease); 3). Renal function: Creatinine clearance (CrCl) ≥30 mL\u002Fmin (calculated by the Cockcroft-Gault formula, except for decreased CrCl caused by underlying disease); 4). Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN; Prothrombin Time (PT) ≤1.5×ULN; 5). Cardiac function: Good hemodynamic stability; 4.Female subjects of child-bearing potential and male subjects with partners of child-bearing potential must use medically-accepted contraceptive measures or practice abstinence during study treatment and for at least 6 months after the end of study treatment. Female subjects of child-bearing potential must have a negative serum HCG test result within 7 days prior to study enrollment and shall not be lactating; 5.Voluntarily participate in this clinical study, provide signed informed consent, have good compliance, and be willing to comply with follow-up procedures.\n\n6.Diagnosed with relapsed\u002Frefractory immune thrombocytopenia (ITP) according to the 2009 International Working Group (IWG) consensus criteria; 7.latelet count \\\u003C50×10⁹\u002FL on at least two consecutive occasions. In addition, peripheral blood smear findings shall support the diagnosis of ITP, with no evidence indicating alternative causes of thrombocytopenia (e.g., pseudothrombocytopenia, myelofibrosis). Physical examination findings shall reveal no diseases other than ITP that may cause thrombocytopenia; 8.Subjects shall have received one or more prior therapies for ITP (including but not limited to glucocorticoids, immunoglobulins, azathioprine, danazol, cyclophosphamide and\u002For rituximab); 9.Subjects must have either a response to one prior ITP therapy (platelet count \\>50×10⁹\u002FL) within the past 3 years, or bone marrow findings consistent with ITP, to rule out myelodysplastic syndrome (MDS) or other alternative causes of thrombocytopenia; 10.Subjects shall have Prothrombin Time (PT) not exceeding ±3 seconds relative to the normal reference range (or the International Normalized Ratio \\[INR\\] within 80%-120% of the normal range); activated partial thromboplastin time (aPTT) not exceeding ±10 seconds relative to the normal reference range; and no history of hypercoagulable state.\n\nExclusion Criteria:\n\n1. Subjects with a severe history of drug allergy or allergic diathesis;\n2. Presence or suspicion of uncontrolled or treatable fungal, bacterial, viral or other infections;\n3. Subjects with intolerable cardiac function;\n4. Subjects with congenital immunoglobulin deficiency;\n5. History of malignant neoplasm within the past 5 years;\n6. Subjects with end-stage renal failure;\n7. Subjects positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody with detectable peripheral blood HCV RNA; subjects positive for human immunodeficiency virus (HIV) antibody; subjects with positive syphilis test;\n8. Presence of psychiatric disorders and severe cognitive impairment;\n9. Participation in another clinical trial within 3 months prior to enrollment;\n10. Use of disease-modifying immunosuppressive agents within five half-lives prior to enrollment, or use of biological agents (including but not limited to mycophenolate mofetil, methotrexate, leflunomide, belimumab, etc.) within 4 weeks prior to enrollment;\n11. Female subjects who are pregnant or planning to become pregnant;\n12. Subjects whom the investigator considers ineligible for enrollment for any other reason.","ALL","18 Years","65 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"NA","Primary Objective: To evaluate the safety and efficacy of CHT105 Injection in subjects with relapsed\u002Frefractory autoimmune diseases.\n\nSecondary Objective:To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of CHT105 Injection.\n\nIndication: Immune Thrombocytopenia (ITP)",[27],"Immune Thrombocytopenia (ITP)","NOT_YET_RECRUITING","2026-09-03",{"date":31,"type":32},"2026-09-10","ACTUAL",{"date":34,"type":21},"2026-09",{"date":36,"type":21},"2027-12",{"name":38,"class":39},"Nanjing Miracle Biotechnology Co., Ltd.","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":60,"locationsCount":40},"100655226","phase-1-a-phase-i-single-arm-open-label-clinical-study-to-evaluate-the-safety-pharmacokinetics-and-preliminary-efficacy-of-cht101-injection-in-subjects-with-relapsedrefractory-t-cell-and-b-cell-hematological-malignancies-100655226","NCT07809126","A Phase I, Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of CHT101 Injection in Subjects With Relapsed\u002FRefractory T-Cell and B-Cell Hematological Malignancies","Inclusion Criteria:\n\n1. Prior to performing any study-related assessments\u002Fprocedures, understand and voluntarily sign the Informed Consent Form (ICF)；\n2. Age between 18 and 70 years (inclusive) at the time of signing the ICF;\n3. Tumor cells in bone marrow or peripheral blood are CD70-positive as detected by flow cytometry; or CD70-positive by immunohistochemistry (IHC) testing of tumor tissue;\n4. Relapsed\u002Frefractory T-cell malignancies with measurable disease defined by modified Severity-Weighted Assessment Tool (mSWAT) score or peripheral blood tumor burden, or at least one measurable lesion detected by imaging (PET-CT or CT) per Lugano criteria (lymph node lesion: any diameter \\>1.5 cm; extranodal lesion: any diameter \\>1.0 cm), and meeting the following criteria: relapsed\u002Frefractory peripheral T-cell lymphoma (including but not limited to peripheral T-cell lymphoma-not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large-cell lymphoma, adult T-cell leukemia\u002Flymphoma) or cutaneous T-cell lymphoma (including but not limited to mycosis fungoides or Sézary syndrome \\[Stage IIB or higher, disease involving two or more regions, or single-region disease with large-cell transformation\\]), and have received prior systemic therapy: patients with peripheral T-cell lymphoma must have received at least 1 line of therapy; patients with cutaneous T-cell lymphoma must have received at least 2 lines of therapy; for anaplastic large-cell lymphoma (ALCL), subjects must have relapsed following prior brentuximab vedotin-containing therapy, or relapsed after ≥2 prior lines of therapy (if anaplastic lymphoma kinase-positive)；\n5. Relapsed\u002Frefractory B-cell malignancies with at least one measurable lesion and meeting at least one of the following criteria:\n\n   Indolent lymphoma (FL, MCL, MZL): relapsed or refractory after at least two lines of therapy, with prior treatment regimens containing anti-CD20 antibody; Chronic lymphocytic leukemia (CLL): relapsed or refractory after at least two lines of therapy, with prior treatment regimens containing both BTK inhibitor and venetoclax; Aggressive or highly-aggressive lymphoma (DLBCL, Burkitt lymphoma, high-grade B-cell lymphoma \\[double-hit, triple-hit, primary mediastinal DLBCL\\]): relapsed or refractory after at least two lines of therapy, with prior treatment regimens containing anti-CD20 antibody and anthracycline, and the subject is ineligible for autologous stem cell transplantation (conditions for ineligibility for autologous stem cell transplantation include lack of disease response after salvage therapy and failure of stem cell mobilization precluding transplantation); Acute lymphoblastic leukemia (ALL): relapsed or refractory after at least two lines of prior therapy；\n6. Histopathologically confirmed classical Hodgkin lymphoma (cHL), which is relapsed or refractory (after brentuximab vedotin and PD-1 inhibitor therapy), with at least one measurable lesion consistent with Lugano 2014 lymphoma response evaluation criteria；\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at the time of signing the ICF;\n8. Expected survival of no less than 12 weeks;\n9. Fertile males and females of child-bearing potential must agree to use effective contraceptive measures from the time of signing the Informed Consent Form (ICF) until 2 years after administration of the study drug. Females of child-bearing potential include pre-menopausal women and women within 2 years post-menopause. A serum pregnancy test must be negative for females of child-bearing potential at screening.\n\nExclusion Criteria:\n\n1. Central nervous system (CNS) metastasis, leptomeningeal disease or metastatic spinal cord compression; or prior history of CNS diseases, including but not limited to seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, etc；\n2. History of organ transplantation;\n3. History of other primary malignancies within 5 years prior to study treatment, with the following exceptions:\n\n   1. Cervical carcinoma in situ that has been adequately treated and cured;\n   2. Localized basal-cell carcinoma or squamous-cell carcinoma of the skin;\n4. Subjects with positive hepatitis B surface antigen (HBsAg) at screening should be excluded; for subjects with negative HBsAg but positive hepatitis B core antibody (HBcAb), those with peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection should be excluded; subjects with positive hepatitis C virus (HCV) antibody and positive HCV RNA should be excluded; subjects with positive human immunodeficiency virus (HIV) antibody; subjects with both positive treponema-specific antibody and non-specific syphilis antibody tests；\n5. Subjects with hypersensitivity to any components of the investigational products used in this study, including but not limited to lymphodepleting agents (cyclophosphamide, fludarabine), and contrast media for imaging examinations；\n6. Prior receipt of anti-CD70-targeted anti-tumor therapy, including but not limited to CD70-targeted cell therapy (autologous or allogeneic), TCR-T therapy, etc；\n7. Prior receipt of CAR-T therapy or other cell\u002Fgene therapy;\n8. Presence of acute or moderate-to-severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to ICF signing, or receipt of systemic pharmacological therapy for GVHD within 4 weeks prior to the first infusion；\n9. Receipt of any investigational drug or systemic anti-tumor therapy within 28 days (or 5 half-lives of the drug, whichever is deemed more appropriate by the Investigator) prior to the first infusion;\n10. Receipt of extensive-field radiotherapy within 28 days prior to the time of signing the ICF, except for local radiotherapy for symptom relief to non-target lesions administered within 14 days prior to ICF signing or anticipated to be administered during the study period；\n11. Receipt of major surgical procedure within 28 days prior to the time of signing the ICF, or anticipated major surgical procedure during the study period；\n12. Uncontrolled active infection requiring parenteral antibiotic, antiviral or antifungal therapy at the time of signing the ICF or within 4 weeks prior to the first infusion;\n13. History of active pulmonary tuberculosis infection within 1 year prior to screening (subjects with history of active pulmonary tuberculosis infection more than 1 year ago are excluded unless the Investigator judges that there is no current evidence of active pulmonary tuberculosis)；\n14. Concurrent or prior history of interstitial lung disease or interstitial pneumonitis;\n15. Subject has active or previously-treated autoimmune disease with potential for recurrence (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis), or is at risk for such disease；\n16. Requirement for systemic corticosteroids at a dose equivalent to or greater than 10 mg\u002Fday prednisone, or other immunosuppressive therapy within 2 weeks prior to the time of signing the ICF or during the study period, except for the following:\n\n    1. Intranasal, inhaled, topical steroids or local steroid injections (e.g., intra-articular injection);\n    2. Systemic corticosteroid therapy at prednisone-equivalent physiological dose no more than 10 mg\u002Fday;\n    3. Steroids used for prophylaxis against allergic reactions (e.g., pre-medication prior to computed tomography \\[CT\\] scanning).\n17. Clinically significant thyroid dysfunction as judged by the Investigator；\n18. Clinically significant cardiovascular disease, including any of the following:\n\n    1. Fridericia-corrected QT interval (QTcF) \\> 470 msec;\n    2. New York Heart Association (NYHA) class II or higher heart failure;\n    3. Left ventricular ejection fraction (LVEF) ≤ 50%;\n    4. Uncontrolled hypertension (systolic blood pressure ≥ 150 mm Hg and\u002For diastolic blood pressure ≥ 95 mm Hg);\n    5. Clinically significant arrhythmias requiring anti-arrhythmic therapy, including but not limited to sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, complete left bundle-branch block;\n    6. Unstable angina or acute myocardial infarction within 6 months prior to the time of signing the ICF.\n19. Insufficient bone marrow reserve or impaired organ function, defined by any of the following laboratory findings:\n\n    1. Absolute neutrophil count (ANC) \\\u003C 1.5 × 10⁹\u002FL;\n    2. Platelet count \\\u003C 50 × 10⁹\u002FL;\n    3. Hemoglobin \\\u003C 70 g\u002FL;\n    4. Abnormal coagulation tests: international normalized ratio (INR) \\> 2.0 or prothrombin time (PT) \\> 1.5 × upper limit of normal (ULN);\n    5. Alanine aminotransferase (ALT) \\> 1.5 × ULN;\n    6. Aspartate aminotransferase (AST) \\> 1.5 × ULN;\n    7. Total bilirubin \\> 1.5 × ULN;\n    8. Serum creatinine clearance \\\u003C 60 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n20. History of bleeding events within 6 months prior to the time of signing the ICF; clinically significant bleeding requiring medical intervention within 28 days prior to screening, including esophageal variceal bleeding;\n21. Receipt of live-attenuated or inactivated vaccines within 28 days prior to the time of signing the ICF, or planned administration of live-attenuated or inactivated vaccines during the screening period;\n22. Subject has comorbidities or other conditions that, in the Investigator's opinion, may impair protocol compliance or render the subject unsuitable for participation in this study;\n23. Female subjects who are pregnant or breastfeeding.","70 Years",{"count":49,"type":21},30,[51],"PHASE1","Primary Objective: To evaluate the safety, tolerability, and dose-limiting toxicity of CD70-targeted chimeric antigen receptor allogeneic T-cell injection (CHT101) in the treatment of subjects with CD70-positive relapsed\u002Frefractory T-cell and B-cell hematological malignancies.\n\nPrimary Endpoint: MTD, RP2D or biologically effective dose; to assess the incidence, severity and relatedness of AEs and SAEs.\n\nIndication: CD70-positive relapsed or refractory T-cell and B-cell hematological malignancies",[54],"Hematological Malignancies",{"date":56,"type":32},"2026-09-09",{"date":34,"type":21},{"date":59,"type":21},"2028-12",{"name":38,"class":39},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":72,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":77,"locationsCount":40},"100655201","phase-1-a-clinical-study-to-evaluate-cht101-injection-in-subjects-with-relapsedrefractory-t-cell-and-b-cell-hematologic-malignancies-100655201","NCT07809139","A Clinical Study to Evaluate CHT101 Injection in Subjects With Relapsed\u002FRefractory T-Cell and B-Cell Hematologic Malignancies","A Phase I, Single-Arm, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of CHT101 Injection in Subjects With Relapsed\u002FRefractory T-Cell and B-Cell Hematological Malignancies","Inclusion Criteria:\n\n1. Understand and voluntarily provide written informed consent (ICF) prior to any study-related assessments\u002Fprocedures;\n2. Aged between 18 and 70 years (inclusive) at the time of ICF signing;\n3. CD70-positive tumor cells detected in bone marrow or peripheral blood by flow cytometry, or positive CD70 immunohistochemistry in tumor tissue;\n4. Subjects with relapsed\u002Frefractory T-cell malignancies with measurable disease as defined by modified Severity-Weighted Assessment Tool (mSWAT) score or peripheral blood tumor burden, or at least one measurable lesion identified by imaging (PET-CT or CT) according to Lugano criteria (lymph node lesion with any diameter \\>1.5 cm; extranodal lesion with any diameter \\>1.0 cm), and meeting the following criteria: relapsed\u002Frefractory peripheral T-cell lymphoma (including but not limited to peripheral T-cell lymphoma-not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large-cell lymphoma, adult T-cell leukemia\u002Flymphoma) or cutaneous T-cell lymphoma (including but not limited to mycosis fungoides or Sézary syndrome \\[stage IIB or higher with disease involving two or more regions, or single-region disease with large-cell transformation\\]), and having received prior systemic therapy: subjects with peripheral T-cell lymphoma shall have received at least one line of therapy; subjects with cutaneous T-cell lymphoma shall have received at least two lines of therapy; for anaplastic large-cell lymphoma (ALCL), subjects must have relapsed following prior brentuximab vedotin therapy, or relapsed after ≥2 prior therapies (if anaplastic lymphoma kinase-positive);\n5. Subjects with relapsed\u002Frefractory B-cell malignancies with at least one measurable lesion and meeting at least one of the following criteria:\n\n   * Indolent lymphoma (FL, MCL, MZL): relapsed or refractory after at least two prior lines of therapy containing a CD20 antibody;\n   * Chronic lymphocytic leukemia (CLL): relapsed or refractory after at least two prior lines of therapy including BTK inhibitor and venetoclax;\n   * Aggressive or highly aggressive lymphoma (DLBCL, Burkitt lymphoma, high-grade B-cell lymphoma \\[double-hit, triple-hit, primary mediastinal DLBCL\\]): relapsed or refractory after at least two prior lines of therapy containing a CD20 antibody and anthracycline, and the subject is ineligible for autologous stem-cell transplantation (conditions for ineligibility for autologous stem-cell transplantation include absence of disease response after salvage therapy, and failure of stem-cell mobilization precluding transplantation);\n   * Acute lymphoblastic leukemia (ALL): relapsed or refractory after at least two prior lines of therapy;\n6. Histopathologically confirmed classical Hodgkin lymphoma (cHL), relapsed or refractory (following BV and PD-1 therapy), with at least one measurable lesion per the Lugano 2014 lymphoma response evaluation criteria;\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at the time of ICF signing;\n8. Expected survival of at least 12 weeks;\n9. Fertile male subjects and female subjects of child-bearing potential must agree to use effective contraception from the time of ICF signing until 2 years after administration of investigational product. Female subjects of child-bearing potential include pre-menopausal women and women within 2 years post-menopause. Serum pregnancy test must be negative for female subjects of child-bearing potential at screening.\n\nExclusion Criteria:\n\n1. Central nervous system (CNS) metastasis, leptomeningeal disease or metastatic central compression; or prior history of CNS diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, etc.;\n2. History of organ transplantation;\n3. History of other primary malignancies within 5 years prior to study treatment, except for: a) adequately treated and cured carcinoma in situ of the cervix; b) localized basal-cell carcinoma or squamous-cell carcinoma of the skin;\n4. Subjects with positive HBV DNA in peripheral blood at screening; subjects positive for hepatitis C virus (HCV) antibody with detectable peripheral blood HCV RNA; subjects positive for human immunodeficiency virus (HIV) antibody; subjects with both positive treponemal-specific antibody and non-treponemal antibody tests for syphilis;\n5. Known allergy to any component of study medications, including but not limited to lymphodepleting agents (cyclophosphamide, fludarabine), contrast media for imaging examinations;\n6. Prior anti-CD70 antitumor therapy, including but not limited to anti-CD70 cell therapy (autologous or allogeneic), TCR-T therapy, etc.;\n7. Prior receipt of CAR-T therapy or other cell\u002Fgene therapy;\n8. Presence of acute or moderate-to-severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to ICF signing, or receipt of systemic medicinal treatment for GVHD within 4 weeks prior to first infusion;\n9. Receipt of any investigational product or systemic antitumor therapy within 28 days prior to first infusion (or five half-lives of the drug, whichever is more appropriate at the investigator's discretion);\n10. Receipt of extensive radiotherapy within 28 days prior to ICF signing, except for local radiotherapy for symptomatic relief of non-target lesions administered within 14 days prior to ICF signing or anticipated during the study period;\n11. Major surgical procedure within 28 days prior to ICF signing, or anticipated major surgical procedure during the study period;\n12. Any uncontrolled active infection requiring parenteral antibiotic, antiviral or antifungal therapy at the time of ICF signing or within 4 weeks prior to first infusion;\n13. History of active pulmonary tuberculosis within 1 year before screening (except for subjects with a history of active pulmonary tuberculosis more than 1 year earlier who are judged by the investigator to have no current evidence of active pulmonary tuberculosis);\n14. Concurrent or prior history of interstitial lung disease or interstitial pneumonia;\n15. Active or previously-occurred autoimmune diseases with potential for relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or at risk for such diseases;\n16. Requirement for systemic corticosteroids (≥10 mg\u002Fday prednisone equivalent) or other immunosuppressive agents within 2 weeks prior to ICF signing or during the study period, except for: a) intranasal, inhaled, topical steroids or local steroid injection (e.g., intra-articular injection); b) systemic corticosteroids at physiological doses ≤10 mg\u002Fday prednisone equivalent; c) steroids for prophylaxis against hypersensitivity reactions (e.g., premedication prior to computed tomography \\[CT\\]);\n17. Clinically significant thyroid dysfunction as judged by the investigator;\n18. Clinically significant cardiovascular disease, including any of the following: a) heart-rate-corrected QT interval (QTcF) \\>470 msec; b) New York Heart Association (NYHA) class II or higher heart failure; c) left ventricular ejection fraction (LVEF) ≤50%; d) uncontrolled hypertension (systolic blood pressure ≥150 mm Hg and\u002For diastolic blood pressure ≥95 mm Hg); e) arrhythmias of clinical significance or requiring antiarrhythmic therapy (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, complete left bundle-branch block, etc.); f) unstable angina or acute myocardial infarction within 6 months prior to ICF signing;\n19. Insufficient bone marrow reserve or organ function meeting any of the following laboratory criteria: a) absolute neutrophil count \\\u003C1.5×10⁹\u002FL; b) platelet count \\\u003C50×10⁹\u002FL; c) hemoglobin \\\u003C70 g\u002FL; d) abnormal coagulation parameters: international normalized ratio (INR) \\>2.0 or prothrombin time (PT) \\>1.5 × upper limit of normal (ULN); e) alanine aminotransferase (ALT) \\>2.5 × ULN; f) aspartate aminotransferase (AST) \\>2.5 × ULN; g) total bilirubin \\>2.5 × ULN; h) serum creatinine clearance \\\u003C60 mL\u002Fmin (calculated by the Cockcroft-Gault formula);\n20. History of bleeding events within 6 months prior to ICF signing; clinically significant bleeding requiring medical intervention within 28 days before screening, including esophageal variceal bleeding;\n21. Vaccination with live-attenuated\u002Finactivated vaccines within 28 days prior to ICF signing, or planned administration of live-attenuated\u002Finactivated vaccines during the screening period;\n22. Subjects whose comorbidities or other circumstances, in the investigator's opinion, may impair protocol compliance or render the subject ineligible for study participation;\n23. Female subjects who are pregnant or breastfeeding.",{"count":49,"type":21},[51],"Primary Objective: To evaluate the safety, tolerability, and dose-limiting toxicity of anti-CD70 chimeric antigen receptor allogeneic T-cell injection (CHT101) in the treatment of CD70-positive relapsed\u002Frefractory T-cell and B-cell hematological malignancies.\n\nSecondary Objectives: To characterize the PK profiles of CHT101; to evaluate the clinical efficacy of CHT101 for CD70-positive relapsed\u002Frefractory T-cell and B-cell hematological malignancies.\n\nIndication: CD70-positive relapsed\u002Frefractory T-cell and B-cell hematological malignancies",[54],[73],"UCAR-T",{"date":56,"type":32},{"date":34,"type":21},{"date":59,"type":21},{"name":38,"class":39},""]