[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphomanon-hodgkin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphomanon-hodgkin":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100555305","phase-2-epcoritamab-in-patients-with-follicular-lymphoma-not-accomplishing-a-cr-with-upfront-chemoimmunotherapy-100555305",false,"NCT06510361","Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy","A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy","Inclusion Criteria:\n\n* Biopsy-confirmed (fresh or archival tissue) follicular lymphoma grade 1-3A that is CD20+ (by immunophenotype or immunohistochemistry) at time of diagnosis. All degrees of CD20 positivity will be accepted. Composite high-grade lymphoma will be excluded.\n* Subjects must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm and short axis \\>1.0 cm and Deauville ≥ 4 seen on baseline PET\u002FCT\n* Stage III\u002FIV at initial diagnosis\n* 1 prior line (at least 3 cycles) of systemic \"upfront\" or first-line therapy consisting of anti-CD20 antibody (e.g. obinutuzumab or rituximab) combined with chemotherapy (e.g. bendamustine, CHOP, CVP, or lenalidomide). Rituximab monotherapy, rituximab plus radiation, or radiation alone is not sufficient.\n* Subjects need to have achieved a partial response or stable disease as best response following upfront treatment. Subjects with progressive disease will be excluded.\n* Subjects must have completed all prior anti-lymphoma therapy at least 4 weeks (28 days) prior to start of epcoritamab.\n* Age ≥18 years.\n* 3.1.7 Age ≥18 years.\n* ECOG performance status ≤ 2\n* Life expectancy of greater than 2 years\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1000 cells\u002Fmcl (G-CSF allowed if marrow involved with disease)\n  * Platelets ≥75,000 cells\u002Fmcl (transfusion allowed if marrow involved)\n  * Hemoglobin ≥ 8 g\u002FdL (transfusion allowed if marrow involved)\n  * Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). In patients with suspected\u002Fknown Gilbert's disease total bilirubin up to 3x ULN will be allowed\n  * AST(SGOT)\u002FALT(SGPT) ≤3× institutional ULN unless suspected\u002Fknown involvement by follicular lymphoma\n  * Creatinine ≤ institutional ULN OR creatinine clearance \\> 45 ml\u002Fmin (by Cockcroft-Gault estimate or 24-hr creatinine clearance measurement)\n* Patients with hepatitis B core antibody positivity with negative PCR on antiviral therapy will be eligible but will be required to receive appropriate antiviral prophylaxis as described in Section 5.4. Patients with Hepatitis C antibody must have undetectable viral load.\n* Participants with a history of prior malignancy will be eligible if all treatment of that malignancy was completed at least 2 years prior to enrollment to this study, the treatment was considered \"curable-intent\", and there is currently no evidence of disease.\n* Resolution of toxicities from prior therapy to baseline or grade ≤1 (with the exception of grade 2 peripheral neuropathy or any grade alopecia)\n* Ability to understand and the willingness to sign a written informed consent document.\n* Females of childbearing potential must agree to practice a highly effective method of birth control (as defined by the EU Clinical Trial Facilitation Group) consistent with local regulations regarding the use of birth control methods for patients participating in clinical trials:\n\n  * Established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception;\n  * Placement of an intrauterine device (IUD) or intrauterine system (IUS);\n  * Male partner sterilization (the vasectomized partner should be the sole partner for that patient)\n  * True abstinence (when this is in line with the preferred and usual lifestyle of the patient)\n* Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of epcoritamab. Men must also not donate sperm during the trial and for 12 months after receiving the last dose of epcoritamab.\n* A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (i.e. use of condom) during the trial and for 12 months after receiving the last dose of epcoritamab.\n\nExclusion Criteria:\n\n* Use of investigational agents incorporated into prior induction therapy\n* Uncontrolled intercurrent active infection requiring hospitalization or intravenous antimicrobial agents within 4 weeks of start of treatment\n* Uncontrolled underlying cardiac conditions including but not limited to congestive heart failure grade III or IV (by NYHA) or EF \\\u003C45%, unstable angina pectoris, acute myocardial infarction \\< 6 months, cardiac arrhythmia\n* History of uncontrolled neurologic condition including but not limited to seizure disorder, stroke, psychosis, dementia, CNS vasculitis, encephalitis\n* EF \\\u003C45% or need for supplemental O2 at rest to maintain SaO2\\>89%\n* Immunosuppressive therapy for non-lymphoma-related indication within 28 days (or for lymphoma within 10 days) of initiation of treatment, including systemic corticosteroids 10 mg\u002Fday or greater of prednisone or equivalent\n* Patients with known or suspected CNS involvement or leptomeningeal disease are excluded given concern for potentially increased risk of neurologic toxicity with epcoritamab. Patients with history of CNS malignancy from separate malignancy must have completed CNS-directed therapy and must currently have no evidence of disease\n* Pregnant or breastfeeding women or participants unwilling to adhere to institutional guidelines for highly effective contraception for the duration of the therapy are excluded. This is because of the unknown but potential risk of teratogenic or abortifacient effects, as well as potential for adverse events in nursing infants secondary to treatment of the mother, as epcoritamab has not yet been studied in this patient population. A female can be determined to not be of childbearing potential if she meets any of the following criteria:\n\n  * Premenarchal\n  * Postmenopausal (\\>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone \\[FSH\\] level \\>40 IU\u002FL or mIU\u002FmL)\n  * Permanently sterilized (e.g., bilateral tubal occlusion \\[which includes tubal ligation procedures as consistent with local regulations\\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy)\n\nNote: If the childbearing potential changes after start of the trial (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described under 3.1.15.\n\n* Known current alcohol or drug abuse, psychiatric illness, or unstable social situation that is likely to limit compliance with study requirements\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab\n* Exposure to a live or a live attenuated vaccine within 4 weeks\n* Patients with HIV will be excluded","ALL","18 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment.\n\nThe name of the study drug in this research study is:\n\n-Epcoritamab (a type of antibody)",[26,27,28,29],"Lymphoma","Follicular Lymphoma","Lymphoma,Non-Hodgkin","Lymphoma, Non-Hodgkin's, Adult",[27,26,31,29],"Lymphoma, Non-Hodgkin","RECRUITING","2026-03-12",{"date":35,"type":36},"2026-03-13","ACTUAL",{"date":38,"type":36},"2024-11-20",{"date":40,"type":20},"2028-05-01",{"name":42,"class":43},"Beth Israel Deaconess Medical Center","OTHER",3,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100576324","a-novel-car-t-combined-expression-of-il-15-in-the-treatment-of-malignant-hematological-tumors-100576324","NCT06783816","A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors","A Multicenter, Single Arm, Open Label Clinical Study on the Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors","Inclusion Criteria:\n\n* I (or the authorized representative\u002Flegal guardian) agree and have signed an informed consent form, and am willing and capable of following the planned visits, research treatments, laboratory tests, and other research procedures;\n* Histopathological or flow cytometric diagnosis of CD19 and\u002For CD22, BCMA-positive hematological malignancies;\n\n  -≥15 years old, ≤80 years old;\n* If you meet one of the following three conditions, you can be included in the group:-Patients with recurrent or refractory hematologic malignancies treated with one standard chemotherapy regimen and one salvage regimen;-Minimal residual lesions persist after treatment with one standard chemotherapy regimen and one salvage regimen;-Patients with recurrence after hematopoietic stem cell transplantation;\n* Estimated survival ≥12 weeks;\n* Good heart, liver and kidney function:\n* Serum creatinine ≤ 1.5 mg\u002FdL (1mg\u002Fdl=88.4umol\u002FL); Serum ALT\u002FAST ≤ 2.5 ULN; Total bilirubin ≤ 1.5 mg\u002Fdl (1mg\u002Fdl=17.1umol\u002FL):\n* Cardiac ejection fraction ≥50%, cardiac ultrasound showed centropericardial effusion:\n* Eastern Oncology Collaborative Group Activity Status Score (ECOG)0-3;\n* Able to understand and voluntarily sign informed consent; If the subject is a child, the guardian will sign the informed consent.\n\nIf the answer to any of the above is \\"no\\", the subject will not be allowed to participate in this study.\n\nExclusion Criteria:\n\n* Have a New York Heart Association (NYHA) classification \\> Class III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically prominent heart disease within one year prior to signing the consent form, or have a QTC interval \\>480ms at the time of screening (QTC interval is calculated using the Fridericia formula);\n* Have active GVHD, or need immunosuppressants;\n* Other malignancies were present within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, and breast ductal carcinoma in situ after radical resection of local prostate cancer;\n* The presence of an active or uncontrolled infection requiring systemic treatment (except for mild genitourinary and upper respiratory tract infections) in the 7 days prior to screening;\n* If HBSAg or HbCAb positive peripheral blood hepatitis B virus (HBV)DNA is higher than the lower limit of detection, it should be excluded. If hepatitis C virus (HCV) antibody positive, peripheral blood HCVRNA positive should be excluded; (HIV) antibody-positive; -Cytomegalovirus (CMV)DNA test positive for human immunodeficiency virus; Those who test positive for Treponema pallidum specific antibody (TPPA) should be excluded;\n* Participating in another clinical trial within 4 weeks prior to the signing of the informed consent, or the signing date of the informed consent is still within 5 half-lives of the drug (whichever is longer) since the last drug used in the last clinical trial;\n* A history of severe allergy to biological products;\n* Systemic diseases that are considered unstable by the investigator: including but not -limited to severe liver, kidney, or metabolic diseases requiring medical treatment;\n* Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partner plans pregnancy within 2 years after cell transfusion;\n* Conditions that the investigator believes may increase the risk to the subject or interfere with the test results.",{"count":53,"type":20},45,[55],"NA","The is a multicenter, single arm, open label clinical study on the novel CAR-T combined expression of IL-15 in the treatment of malignant hematological tumors.Plan to recruit 45 subjects with malignant hematological tumors.",[58,28,59],"Acute Lymphocytic Leukemia","Relapsed Refractory Multiple Myeloma",[61,62,63],"CAR-T","IL-15","malignant hematological tumors","2025-01-15",{"date":66,"type":36},"2025-01-20",{"date":68,"type":36},"2023-12-01",{"date":70,"type":20},"2028-06-01",{"name":72,"class":43},"Shanxi Bethune Hospital",1]