[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655201":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":11,"studyPopulation":11,"armGroups":37,"interventions":43,"overallOfficials":11,"centralContacts":49,"locations":55,"responsibleParty":73,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":11,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":11,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Nanjing Miracle Biotechnology Co., Ltd.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Maximum tolerated dose (MTD)",null,"Day 28",{"measure":14,"description":11,"timeFrame":15},"To assess the incidence, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs).","Throughout the study period, up to 24 months",[17,20,23,25,27,29],{"measure":18,"description":11,"timeFrame":19},"Peripheral blood CAR-T cell proportion","Day 1,Day 2,Day 4,Day 7,Day 11,Day 14,Day 18,Day 21,Day 28,Month 2,Month 3,Month 4,Month 5,Month 6,Month 9,Month 12,Month 15,Month 18,Month 21,Month 24",{"measure":21,"description":11,"timeFrame":22},"ORR","Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24",{"measure":24,"description":11,"timeFrame":22},"DOR",{"measure":26,"description":11,"timeFrame":22},"PFS",{"measure":28,"description":11,"timeFrame":22},"OS",{"measure":30,"description":11,"timeFrame":19},"Peripheral blood CAR copy number",{"allocation":32,"interventionModel":33,"interventionModelDescription":11,"primaryPurpose":34,"observationalModel":11,"timePerspective":11,"maskingInfo":35},"NA","SINGLE_GROUP","TREATMENT",{"masking":36,"maskingDescription":11,"whoMasked":11},"NONE",[38],{"label":39,"type":40,"description":11,"interventionNames":41},"Experimental group","EXPERIMENTAL",[42],"Drug: CHT101",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"DRUG","CHT101","Single-dose and multiple-dose administration Method of Administration: Intravenous infusion Dose of Administration:3.6\\*10\\^9 CAR-T cells,7.2\\*10\\^9 CAR-T cells,10\\*10\\^9 CAR-T cells.",[39],[50],{"name":51,"role":52,"phone":53,"phoneExt":11,"email":54},"Chao Dai","CONTACT","15850641905","chao.dai@njmiracle.com",[56],{"facility":57,"status":11,"city":58,"state":59,"zip":11,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Jiangxi Cancer Hospital","Nanchang","Jiangxi","China","CN",{"type":63,"coordinates":64},"Point",[65,66],115.85306,28.68396,{"lat":66,"lon":65},[69],{"name":70,"role":52,"phone":71,"phoneExt":11,"email":72},"Wuping Li","13870659916","18907001021@163.com",{"type":74,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[76],{"name":77,"class":6},"Jiangxi Provincial Cancer Hospital","100655201","phase-1-a-clinical-study-to-evaluate-cht101-injection-in-subjects-with-relapsedrefractory-t-cell-and-b-cell-hematologic-malignancies-100655201",false,"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.","ALL","18 Years","70 Years",{"count":89,"type":90},30,"ESTIMATED","INTERVENTIONAL",[93],"PHASE1","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",[96],"Hematological Malignancies",[98],"UCAR-T","NOT_YET_RECRUITING","2026-09-03",{"date":102,"type":103},"2026-09-09","ACTUAL",{"date":105,"type":90},"2026-09",{"date":107,"type":90},"2028-12",{"name":5,"class":6},1]