[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630271":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":20,"overallStatus":68,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Tcelltech Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"In Vivo CAR-T Therapy for Relapsed or Refractory Hematologic Malignancies","EXPERIMENTAL","Participants with relapsed or refractory hematologic malignancies will receive 1-2 intraveneous administrations of in Vivo CAR-T (DIT101).",[13],"Biological: In Vivo CAR-T Therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","In Vivo CAR-T Therapy","Participants will receive 1 intravenous administration of DIT101, according to the study dosing regimen. A second dose at the same dose may be administered to eligible participants who show no response after initial treatment, upon sponsor approval.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Gangxiong Huang, MD","STUDY_CHAIR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Rui Feng, MD","CONTACT","+(86)13509312934","fengrui@tcelltech.com",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Xianzhen Chen, MM","+(86)18649725652","chenxianzhen@tcelltech.com",[36],{"facility":37,"status":20,"city":38,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":20},"Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)","Tianjin","China","CN",{"type":42,"coordinates":43},"Point",[44,45],117.17667,39.14222,{"lat":45,"lon":44},{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100630271","phase-1-safety-and-efficacy-of-dit101-in-relapsed-or-refractory-hematologic-malignancies-100630271",false,"NCT07485504","Safety and Efficacy of DIT101 in Relapsed or Refractory Hematologic Malignancies","A Prospective, Single-Arm Study Evaluating the Safety and Efficacy of DIT101 in Subjects With Relapsed or Refractory Hematologic Malignancies","Inclusion Criteria:\n\n* Adults aged 18 to \\\u003C70 years, any gender.\n* Voluntarily provide written informed consent and willing to comply with all study procedures.\n* Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia\u002Flymphoma (B-ALL\u002FLBL), or other relapsed\u002Frefractory hematologic malignancies as judged by the investigator and confirmed by the collaborating institution.\n* Tumor cells confirmed positive for the target antigen by immunophenotyping.\n* Bone marrow blast ≥5% at screening and\u002For presence of extramedullary disease.\n* For B-ALL\u002FLBL patients, meets criteria for relapsed\u002Frefractory disease, including:\n\n  * Primary refractory after ≥2 cycles of standard chemotherapy or not achieving CR after multiple salvage regimens;\n  * Relapse within 12 months after CR or ≥12 months relapse after CR not achieving CR after subsequent standard therapy;\n  * Relapse after hematopoietic stem cell transplantation;\n  * Relapse after prior CAR-T therapy targeting the same antigen.\n* ECOG performance status 0-2.\n* Expected survival \\>3 months.\n* Adequate organ function, including:\n\n  * Renal: creatinine clearance \\>45 mL\u002Fmin;\n  * Hepatic: total bilirubin ≤3×ULN, ALT\u002FAST ≤5×ULN;\n  * Coagulation: PT, APTT, or INR ≤1.5×ULN;\n  * Cardiac: LVEF ≥50% within 1 month;\n  * Pulmonary: SpO₂ ≥92% at rest on room air;\n  * Hematologic and immune function considered sufficient to tolerate study treatment.\n* Women of childbearing potential must have a negative pregnancy test; women considered not of childbearing potential include those who are postmenopausal for ≥12 months or have undergone surgical sterilization (hysterectomy or bilateral oophorectomy).\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Known hereditary bone marrow failure syndromes (e.g., Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other known marrow failure syndromes).\n* Uncontrolled active central nervous system leukemia (CNSL; CNS2 or CNS3).\n* Prior anti-cancer therapy before screening, including:\n\n  * Systemic chemotherapy within 1 week;\n  * Systemic immunotherapy\u002Ftargeted therapy (monoclonal antibodies, bispecific antibodies, ADCs, etc.) with last dose \\\u003C5 half-lives or \\\u003C4 weeks (whichever is shorter);\n  * Donor lymphocyte infusion within 6 weeks;\n  * CAR-T therapy or hematopoietic stem cell transplantation within 3 months;\n  * Radiotherapy within 4 weeks (unless bone marrow reserve \\>5% and investigator judges it does not affect eligibility);\n  * Persistent clinically significant toxicity from prior therapy not recovered to ≤CTCAE Grade 1 (except alopecia).\n* Uncontrolled severe active infection.\n* History of significant cardiac disease, including: severe heart failure (NYHA class III-IV), myocardial infarction or PCI\u002Fstent within 12 months, unstable angina, QTc \\>480 ms, or other clinically significant arrhythmia per investigator judgment.\n* History of CNS injury, seizure, stroke, or brain hemorrhage requiring treatment within 6 months.\n* Active viral infections:\n\n  * HIV antibody positive, syphilis serology positive;\n  * HBsAg \\>10⁶ IU\u002FmL;\n  * HCV antibody positive;\n  * EBV positive (EBER or copy number above normal).\n* Need for long-term systemic corticosteroid therapy during DIT-101 infusion (local or inhaled steroids allowed).\n* Active autoimmune disease requiring treatment, immunodeficiency, or use of immunosuppressive therapy.\n* Acute or moderate-to-severe chronic graft-versus-host disease (GvHD) within 4 weeks prior to screening.\n* Known severe allergy to any component of DIT-101.\n* Women of childbearing potential or men unable to use effective contraception during DIT-101 infusion and for 1 year post-infusion; plans for pregnancy within 1 year post-infusion in male or female subjects or their partners.\n* Any condition that, in the investigator's opinion, may increase risk or interfere with study outcomes.\n* Prior malignancy other than hematologic malignancy, except:\n\n  * Malignancy treated with curative intent and disease-free ≥2 years;\n  * Non-melanoma skin cancer adequately treated with no current evidence of disease.","ALL","18 Years","70 Years",{"count":60,"type":61},15,"ESTIMATED","INTERVENTIONAL",[64],"PHASE1","This study is a single-arm, open-label clinical trial designed to evaluate the safety and tolerability of DIT101 in adults with relapsed or refractory hematologic malignancies and to explore its potential anti-tumor effects.\n\nDIT101 is an investigational in vivo CAR-T cell therapy administered by intravenous infusion. After administration, it is intended to generate CAR-T cells within the patient's body that can recognize and attack tumor cells. Unlike approved autologous CAR-T therapies, DIT101 does not require collection and ex vivo genetic modification of the participant's own cells.\n\nThe study includes a screening period, DIT101 infusion treatment, a post-treatment intensive follow-up period of approximately 6 months, and a long-term follow-up period of up to 2 years, with visits every 3-6 months.",[67],"Relapsed or Refractory Hematologic Malignancies","NOT_YET_RECRUITING","2026-03-16",{"date":71,"type":72},"2026-03-20","ACTUAL",{"date":74,"type":61},"2026-04-15",{"date":76,"type":61},"2028-10-15",{"name":5,"class":6},1]