[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-hematologic-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-hematologic-malignancies":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,67,87,112],{"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},"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":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Relapsed or Refractory Hematologic Malignancies","NOT_YET_RECRUITING","2026-03-16",{"date":31,"type":32},"2026-03-20","ACTUAL",{"date":34,"type":21},"2026-04-15",{"date":36,"type":21},"2028-10-15",{"name":38,"class":39},"Tcelltech Inc.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":52,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100350139","phase-1-tolerability-study-of-trichostatin-a-in-subjects-with-relapsed-or-refractory-hematologic-malignancies-100350139","NCT03838926","Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies","Inclusion Criteria:\n\n* Subject is ≥ 18 years at the time of signing informed consent;\n* Confirmed malignant hematologic disease or lymphoid malignancy that has relapsed or is refractory to standard therapy and has exhausted all available therapies;\n* Presence of measurable or evaluable disease;\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;\n* Contraceptives or other approved avoidance of pregnancy measures\n\nExclusion Criteria:\n\n* Allogeneic stem cell transplant recipient presenting with graft versus host disease (GVHD) either active or requiring immunosuppression;\n* Concomitantly taking anti-cancer therapy (bisphosphonates are permitted);\n* Undergone major surgery ≤ 2 weeks prior to starting study drug;\n* Evidence of mucosal or internal bleeding;\n* Impaired cardiac function or conduction defect;\n* Concurrent severe and\u002For uncontrolled medical conditions",{"count":48,"type":21},42,[24],"The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.",[27],[53,54,55,56],"Hematologic","Malignancies","Cancer","Blood","RECRUITING","2026-03-12",{"date":29,"type":32},{"date":61,"type":32},"2018-09-27",{"date":63,"type":21},"2027-12",{"name":65,"class":39},"Vanda Pharmaceuticals",11,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":85,"locationsCount":40},"100606287","phase-1-a-phase-i-study-of-qls2309-injection-in-patients-with-cd70-relapsedrefractory-hematologic-malignancies-100606287","NCT07173595","A Phase I Study of QLS2309 Injection in Patients With CD70+ Relapsed\u002FRefractory Hematologic Malignancies","A Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of QLS2309 Injection in Patients With CD70+ Relapsed\u002FRefractory Hematologic Malignancies","Inclusion Criteria:\n\n* 1\\. Subjects voluntarily participated and signed a written informed consent form\n* Age ≥ 18 years, male or female\n* ECOG performance status of 0-2\n* Expected life-expectancy ≥ 3 months\n* CD70+ relapsed\u002Frefractory hematologic malignancies\n* Adequate organ function prior to QLS2309 administration\n* Female patients with fertility must agree to the use of effective contraceptive methods during the study period and within 35 days of discontinuation of the trial drug.\n* Male patients whose sexual partners are women of childbearing age must agree to use condoms during the study period and within 35 days of discontinuation of the trial drug during sexual intercourse.\n\nExclusion Criteria:\n\n* Prior treatment with CD70-related antibodies, antibody-conjugated drugs (ADCs) or cell therapy products\n* Symptomatic central nervous system (CNS) involvement, leptomeningeal metastasis or spinal cord compression caused by metastasis\n* An active autoimmune diseases or known history of ≥ grade 3 irAE due to prior immunotherapy\n* Known history of other active malignant tumor within 3 years\n* Known history of chemotherapy, biological therapy, endocrine therapy, immunotherapy, monoclonal antibodies, etc. within 4 weeks\n* Known history of active hepatitis B\u002FC infection, HIV infection, Treponema pallidum infection",{"count":75,"type":21},186,[24],"This is a single-arm, open-label, multicenter, dose-escalation, dose-expansion and efficacy-expansion phase I clinical study to evaluate the tolerability, safety, pharmacokinetics and preliminary antitumor activity of QLS2309 injection in patients with CD70+ relapsed\u002Frefractory hematologic malignancies.",[27],"2025-12-29",{"date":81,"type":32},"2026-01-02",{"date":83,"type":32},"2025-12-05",{"date":63,"type":21},{"name":86,"class":39},"Qilu Pharmaceutical Co., Ltd.",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100601185","phase-1-a-clinical-study-of-bt02-in-patients-with-relapsed-or-refractory-hematologic-malignancies-100601185","NCT07107204","A Clinical Study of BT02 in Patients With Relapsed or Refractory Hematologic Malignancies","A Multicenter, Open-label, Single-arm Phase Ib\u002FIIa Clinical Study to Evaluate the Safety and Efficacy of BT02 in Patients With Relapsed or Refractory Hematologic Malignancies","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent by the participant or their legal guardian and being willing and able to comply with all trial procedures.\n2. Age:≥18 and \\\u003C70 years, any gender.\n3. Diagnosis:Confirmed hematologic malignancy (leukemia, lymphoma, or multiple myeloma) .\n4. Leukemia-Specific Requirement:Bone marrow blast count ≥5% (morphological) at screening.\n5. Measurable Disease.\n6. Relapsed\u002FRefractory Status.\n7. Adequate organ and hematologic function.\n8. An ECOG activity status score of 0-1.\n9. A life expectancy of ≥ 3 months.\n10. Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia (APL).\n2. Patients with hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome.\n3. Patients with isolated extramedullary leukemia and multiple myeloma.\n4. Patients with uncontrolled active central nervous system leukemia (CNSL).\n5. Patients who have received anticancer therapy prior to administration.\n6. A history of active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years.\n7. A history of clinically significant cardiovascular disease, severe cardiac rhythm\u002Fconduction abnormalities ,severe pulmonary disease that may lead to severe episodes of dyspnea,head trauma, impaired consciousness, epilepsy, cerebral ischemia, or cerebral hemorrhagic disease.\n8. A severe acute or chronic infection when enrollment.\n9. Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .\n10. Unresolved \\> grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.\n11. Patients undergoing acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD or systemic GVHD therapy.\n12. A history of other type of malignancies.\n13. Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.\n14. Poor compliance.\n15. A history of alcohol\u002Fdrugs abuse.\n16. Current pregnancy or breastfeeding.\n17. Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.",{"count":95,"type":21},116,[24,97],"PHASE2","The goal of this clinical trial is to learn about the safety, tolerability and preliminary effectiveness of a treatment for patients with relapsed or refractory hematologic malignancies, regardless of gender, aged between 18(inclusive) and 70 years .\n\nParticipants will receive the investigational product intravenously every two or three weeks. The treatment will continue for a maximum of two years for those who do not show signs of disease progression or experience intolerable side effects.",[27,100,101,102],"Leukemia","Lymphoma","Multiple Myeloma (MM)","2025-09-15",{"date":105,"type":32},"2025-09-17",{"date":107,"type":21},"2025-10",{"date":109,"type":21},"2028-04",{"name":111,"class":39},"Biotroy Therapeutics",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":40},"100535474","phase-1-a-clinical-study-of-sctc21c-in-participants-with-cd38-hematologic-malignancies-100535474","NCT06252298","A Clinical Study of SCTC21C in Participants With CD38+ Hematologic Malignancies","A Phase I Clinical Study Evaluating the Safety and Efficacy of SCTC21C in Participants With CD38+ Hematologic Malignancies","Inclusion Criteria:\n\n1. Male or female aged ≥ 18 years old when signing ICF, weight ≥ 40 kg, ≤ 90 kg\n2. Relapsed or refractory CD38+（confirmed by immunohistochemistry or flow cytometry） hematologic malignancies\n3. Standard therapies failed or are unavailable or intolerant\n4. Participants have at least one of the measurable lesions\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n6. Life expectancy ≥3 months\n7. Participants with basically normal liver, kidney and heart functions\n8. Hematology requirements: platelet≥75x10\\^9 \u002FL,absolute neutrophil counts ≥ 1.0x10\\^9 \u002FL, hemoglobin ≥ 8.0 g\u002FdL\n9. Women of childbearing potential (must have a negative blood pregnancy test within 7 days before the first dose) or male participants must use a highly effective method of contraception from signed ICF to 5 months after the last dose.All participants are prohibited from donating sperms or ova during the study period and 5 months after the last dose\n\nExclusion Criteria:\n\n1. A history of allergic reactions to any SCTC21C injection or any excipients, or Participants with a history of severe drug allergy\n2. Participants who have other antineoplastic drug (except hormones) or radiotherapy within four weeks prior to the first dose of study drug, or the participants who have received immunotherapy or anti-CD38 monoclonal antibody within 6 months\n3. Adverse events from the previous treatment have not resolved to ≤ Grade 1\n4. Participants with prior immunotherapy and Grade ≥ 3 cytokine release syndrome(CRS)\n5. Central nervous system involvement\n6. Participants with positive Human immunodeficiency virus (HIV) antibody\n7. HBsAg positive with HBV-DNA titer higher than the lower limit of the test value of the research center, or HCV antibody positive with HCV-RNA titer higher than the lower limit of the test value of the research center\n8. Active infections that require systemic treatment within 1 week prior to the first dose\n9. History of additional malignant tumor or active autoimmune diseases,or participants with other serious medical conditions\n10. Participants underwent major surgery within 4 weeks prior to the first dose, or had a surgical schedule during the study period\n11. History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation,or history of autologous hematopoietic stem cell transplantation within 6 months prior to screening\n12. Participants with significant digestive system dysfunction that may affect drug intake, transport and absorption\n13. Participants who have received live vaccines within 30 days prior to the first dose of study drug\n14. Participants with mental disorders or poor compliance\n15. Female participants who are breastfeeding\n16. The Investigator determined that the participant is ineligible for the study for other reasons",{"count":120,"type":21},74,[24],"The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies",[27],"2024-04-19",{"date":126,"type":32},"2024-04-22",{"date":128,"type":32},"2024-02-28",{"date":130,"type":21},"2027-02-28",{"name":132,"class":39},"Sinocelltech Ltd."]