[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Essen Biotech\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":496},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,73,113,148,177,202,229,255,290,312,337,363,389,409,429,449,472],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":42,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100624504","phase-1-biomarker-guided-allogeneic-single-target-or-dual-target-car-nk-cell-therapy-for-advanced-solid-tumors-100624504",false,"NCT07410494","Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors","A Phase 1\u002F2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and\u002For Liquid Biopsy Profiling in Participants With Relapsed\u002FRefractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)","SELECT-CAR-NK","Inclusion Criteria:\n\n* Age 18-75 years.\n* Histologically or cytologically confirmed advanced\u002Funresectable or metastatic solid tumor that is relapsed\u002Frefractory after standard therapy, or no standard therapy available.\n* Targetable antigen positivity from the protocol target menu based on:\n\ntissue biopsy and\u002For liquid biopsy platform (as defined in the lab manual).\n\n* Arm assignment rules :\n* Arm A: ≥1 antigen meets \"positive\" threshold\n* Arm B: ≥2 antigens meet \"positive\" threshold\n* ECOG performance status 0-1 (or 0-2 ).\n* At least one measurable lesion by RECIST 1.1.\n* Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits.\n* Willingness to undergo blood draws and required biopsies (when medically feasible).\n* Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment.\n\nExclusion Criteria:\n\n* Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .\n* Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV\u002FHCV with detectable viral load (per local policy).\n* Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).\n* Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.\n* Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk.\n* Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).\n* Pregnant or breastfeeding.","ALL","8 Years","85 Years",{"count":21,"type":22},85,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This Phase 1\u002F2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and\u002For liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.",[29,30,31,32,33,34,35,36,37,38,39,40,41],"Cancer","Breast Cancer","Non-Small Cell Lung Cancer (NSCLC)","Colorectal Cancer (Locally Advanced or Metastatic)","Prostate Cancer - Recurrent","Pancreatic Ductal Adenocarcinoma (PDAC)","Ovarian Cancer","Glioblastoma","Melanoma (Skin Cancer)","Acute Myeloid Leukemia (AML)","Non Hodgkin Lymphoma","Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","Liver Cancer",[43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59],"CAR-NK","Solid tumor","Dual-target CAR","ctDNA","CAR-T","Breast cancer","Non-small cell lung cancer (NSCLC)","Colorectal cancer (CRC)","Prostate cancer","Pancreatic ductal adenocarcinoma (PDAC)","Ovarian, fallopian tube, and primary peritoneal cancers","Glioblastoma and other high-grade gliomas","Melanoma","Acute myeloid leukemia (AML)","Non-Hodgkin lymphoma (NHL), especially DLBCL and follicular lymphoma","Multiple myeloma (especially relapsed\u002Frefractory)","Liver cancer (hepatocellular carcinoma, HCC)","RECRUITING","2026-02-14",{"date":63,"type":64},"2026-02-18","ACTUAL",{"date":66,"type":64},"2026-02-01",{"date":68,"type":22},"2028-12-28",{"name":70,"class":71},"Essen Biotech","OTHER",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":97,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":110,"leadSponsor":112,"locationsCount":72},"100624518","phase-1-ebnk-001-allogeneic-nk-cells-with-low-dose-il-15--pembrolizumab-in-advanced-solid-tumors-100624518","NCT07410676","EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors","An Open-Label Phase 1\u002F2 Study of EBNK-001, an Allogeneic Natural Killer (NK) Cell Therapy Administered After Cyclophosphamide\u002FFludarabine Lymphodepletion With Low-Dose Interleukin-15, With or Without Pembrolizumab, in Participants With Advanced Solid Tumors","EBNK-ST-001","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed advanced\u002Fmetastatic solid tumor that is relapsed\u002Frefractory after standard therapy (or no standard therapy available).\n* Measurable disease per RECIST v1.1 (or iRECIST if applicable).\n* ECOG performance status 0-1 (or 0-2 as allowed).\n* Adequate organ function (thresholds modeled on NK protocols):\n* Platelets ≥ 75,000\u002FµL; hemoglobin ≥ 9 g\u002FdL; ANC ≥ 1,000\u002FµL (unsupported by growth factors\u002Ftransfusions as defined).\n* eGFR ≥ 60 mL\u002Fmin\u002F1.73m².\n* AST\u002FALT ≤ 3× ULN.\n* Oxygen saturation ≥ 90% on room air (with PFT requirements if indicated).\n* LVEF ≥ 40% (by ECHO\u002FMUGA\u002FCMR).\n* If brain metastases are present, they must be stable for a defined period (example: ≥3 months) and not requiring escalating steroids.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Any condition requiring systemic immunosuppression (e.g., \\>5 mg prednisone\u002Fday or equivalent) during dosing window (topical\u002Finhaled may be allowed).\n* Active autoimmune disease requiring systemic immunosuppression.\n* Uncontrolled bacterial, fungal, or viral infection.\n* Receipt of investigational agent within 28 days before first study drug.\n* Live vaccine within 6 weeks prior to lymphodepletion.\n* Known HIV positivity or active hepatitis B\u002FC with detectable viral load (protocol may allow chronic asymptomatic hepatitis depending on risk plan).\n* Known allergy to investigational product components (example: albumin\u002Fhuman or DMSO).\n* Any medical\u002Fsocial condition likely to interfere with study compliance or increase risk.",{"count":82,"type":22},83,[25,26],"This Phase 1\u002F2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of EBNK-001 (allogeneic NK cells) given after lymphodepleting cyclophosphamide\u002Ffludarabine (CY\u002FFLU) and supported with low-dose IL-15, administered either alone or in combination with pembrolizumab in adults with advanced\u002Fmetastatic solid tumors. The study will determine a recommended Phase 2 dose (RP2D) and explore signals of clinical activity using RECIST-based response criteria.",[29,86,87,88,89,90,37,91,92,93,94,35,95,36,96],"Sarcoma","Leukaemia","Breast Cancer (Locally Advanced or Metastatic)","Lung Cancer (Diagnosis)","Colorectal Cancer","Bladder Cancer","Kidney Cancer","Pancreatic Cancer Metastatic","Liver Cancer (Primary and Metastatic)","Esophageal Cancer","Non-Melanoma Skin Cancer",[98,99,100,101,30,102,103,104,47,96,55,91,105,106,107,95],"Natural killer cells","NK cell therapy","Solid tumors","IL-15","Lung and Bronchus Cancer","Prostate Cancer","Colorectal (Colon and Rectal) Cancer","Kidney (Renal Cell and Renal Pelvis) Cancer","Pancreatic Cancer","Stomach (Gastric) Cancer",{"date":63,"type":64},{"date":66,"type":64},{"date":111,"type":22},"2029-12-21",{"name":70,"class":71},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":126,"conditions":127,"keywords":135,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":72},"100532502","phase-1-fourth-gen-car-t-cells-targeting-cd19cd22-for-highly-resistant-b-cell-lymphomaleukemia-pmbclcns-bcl-100532502","NCT06213636","Fourth-gen CAR T Cells Targeting CD19\u002FCD22 for Highly Resistant B-cell Lymphoma\u002FLeukemia (PMBCL\u002FCNS-BCL).","T-cell Infusion Targeting CD19 and CD22 for Refractory\u002FRelapsed Leukemia\u002FLymphoma Patients With or Without Central Nervous System Involvement","BAH241","Inclusion Criteria:\n\n* Diagnosis: ALL In view of the PI and the primary oncologist, there must be no available alternative curative therapies or subject has declined to pursue alternative therapy; and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, recurred after SCT, or have disease activity that prohibits SCT at the time of enrollment.\n* Chemotherapy refractory disease in subjects with B-ALL is defined as progression or stable disease after two lines of therapies\n* Recurrence of disease after achieving a complete response (CR).\n* Subjects with persistent or relapsed minimal residual disease (MRD) (by flow cytometry, PCR, FISH, or next generation sequencing) require verification of MRD positivity on two occasions at least 4 weeks apart.\n* Subjects with Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ALL) subjects are eligible if they progressed, had stable disease or relapsed after two lines of therapy, including tyrosine kinase inhibitors (TKIs).\n* Subjects with recurrence of isolated CNS relapse after achieving complete remission (CR); if relapsed with MRD, will require verification of MRD positivity on two occasions at least 4 weeks apart.\n* Diagnosis: Lymphoma Subjects with lymphoma must have progressed, had SD, or recurred after initial treatment regimens that include an anthracycline and an anti CD20 monoclonal antibody. Subjects who relapse ≥12 months after therapy should have progressed after autologous transplant or been ineligible for autologous transplant.\n* CD19 expression CD19 expression is required at any time since diagnosis. If patient has received anti-CD19 targeted therapy (i.e. Blinatumomab), then CD19 expression must be subsequently demonstrated. CD19 expression. must be detected on greater than 50% of the malignant cells by immunohistochemistry or ≥ 90% by flow cytometry. The choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each subject. In general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples.\n* Subjects who have undergone autologous SCT with disease progression or relapse following SCT will be eligible if all other eligibility criteria are met. Subjects who have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, they are at least 100 days post-transplant, they have no evidence of active GVHD and have been without immunosuppressive agents for at least 30 days.\n* Subjects who have undergone prior anti-CD19 or anti-CD22 CAR therapy will be eligible if \\\u003C 5% of circulating levels of CD3+ cells express the previous CAR by flow cytometry.\n* Must have evaluable or measurable disease; subjects with lymphoma must have evaluable or measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma\\[66\\] must be present. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n* At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory\u002Fstimulatory immune checkpoint therapy, which requires 5 half-lives.\n* Exceptions:\n* There is no time restriction with regard to prior intrathecal chemotherapy (incl. steroids) provided there is complete recovery from any acute toxic effects of such; g. Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis; h. Subjects who are on standard ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine or oral methotrexate) may be enrolled provided that chemotherapy is discontinued at least 1 week prior to apheresis.\n* Subjects receiving steroid therapy at physiologic replacement doses (≤ 5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids) only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis; j. For radiation therapy: Radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable\u002Fevaluable disease outside the radiation port.\n* Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities, such as alopecia, nutritional support measures, electrolyte abnormalities, or those not impacting the investigator's ability to assess treatment emergent toxicities)\n* Age Greater than or equal to 1 year of age and less than or equal to 30 years of age at time of enrollment; must meet parameters for apheresis per institutional guidelines. NOTE: The first subject in the first dose cohort must be ≥ 18 years of age if an adult has not been treated at that dose cohort on the companion Stanford protocol \"Phase 1 Dose Escalation Study of CD19\u002FCD22 Chimeric Antigen Receptor (CAR) T Cells in Adults with Recurrent or Refractory B Cell Malignancies\" and undergone safety evaluation at Day 28 without evidence of DLT.\n* Performance Status: Subjects \\> 10 years of age: Karnofsky ≥ 50%; Subjects ≤ 10 years of age: Lansky scale ≥ 50% (See Appendix B Section 14.2)\n* Normal Organ and Marrow Function (supportive care is allowed per institutional standards, i.e. filgrastim, transfusion)\n* ANC ≥750\u002FuL\\*\n* Platelet count ≥50,000\u002FuL\\*\n* Absolute lymphocyte count ≥150\u002FuL\\*\n* Adequate renal, hepatic, pulmonary and cardiac function defined as:\n* Serum ALT\u002FAST ≤10 ULN (unless elevated ALT\u002FAST is attributed to leukemia or lymphoma involvement of the liver, in which case this criterion will be waived and not disqualify a patient).\n* Total bilirubin ≤1.5 mg\u002Fdl, except in subjects with Gilbert's syndrome.\n* Cardiac ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n* No clinically significant pleural effusion\n* Baseline oxygen saturation \\>92% on room air at rest\n* creatinine: within age adjusted normal institutional limits (see table below) OR\n* creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 (as estimated by Cockcroft Gault Equation) for subjects with creatinine levels above institutional normal.\n* Age (Years) Maximum Serum Creatinine (mg\u002FdL)\n\n  -≤5 0.8 5 \\\u003C age ≤ 10 1.0 \\>10 1.2\n* if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia ≥ Grade 3 if it is due to disease, based on the results of bone marrow studies.\n* CNS Status\n* Subjects with ALL\n* Subjects with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy:\n* CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs;\n* CNS 2, defined as presence of \\\u003C 5\u002FµL WBCs in CSF and cytospin positive for blasts, or \\> 5\u002FµL WBCs but negative by Steinherz\u002FBleyer algorithm:\n\nCNS 2a: \\\u003C10\u002FµL RBCs; \\\u003C 5\u002FµL WBCs and cytospin positive for blasts; CNS 2b: ≥10\u002FµL RBCs; \\\u003C 5\u002FµL WBCs and cytospin positive for blasts; CNS 2c: ≥10\u002FµL RBCs; ≥5\u002FµL WBCs and cytospin positive for blasts but negative by Steinherz\u002FBleyer algorithm.\n\n* Subjects with lymphoma\n* Subjects must have no signs or symptoms of CNS disease or detectable evidence of CNS disease on MRI at the time of screening. Subjects who have previously been treated for CNS disease and who have the following CNS status will be eligible:\n* CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs;\n* CNS 2, defined as presence of \\\u003C 5\u002FµL WBCs in CSF and cytospin positive for blasts, or \\> 5\u002FµL WBCs but negative by Steinherz\u002FBleyer algorithm:\n* CNS 2a: \\\u003C 10\u002FµL RBCs; \\\u003C 5\u002FµL WBCs and cytospin positive for blasts;\n* CNS 2b: ≥ 10\u002FµL RBCs; \\\u003C 5\u002FµL WBCs and cytospin positive for blasts;\n* CNS 2c: ≥ 10\u002FµL RBCs; ≥ 5\u002FµL WBCs and cytospin positive for blasts but negative by Steinherz\u002FBleyer algorithm.\n* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)\n* Contraception Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four (4) months after receiving the preparative regimen.\n* Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous\u002Funknown effects on the fetus.\n* Ability to give informed consent. All subjects ≥ 18 years of age must be able to give informed consent. For subjects \\\u003C18 years old their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent. Pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those \\> 7 years of age, when appropriate.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria are not eligible for participation in the study:\n\n* Recurrent or refractory ALL limited to isolated testicular.\n* Subjects with radiologically-detected CNS lymphoma or CNS 3 disease (presence of ≥ 5\u002FµL WBCs in CSF and cytospin positive for blasts \\[in the absence of a traumatic lumbar puncture\\] and\u002For clinical signs of CNS leukemia).\n* Hyperleukocytosis (≥ 50,000 blasts\u002FµL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.\n* History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years.\n* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.\n* Ongoing infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) as the immunosuppression contained in this study will pose unacceptable risk. A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n* CNS disorder such as cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that in the judgment of the investigator may impair the ability to evaluate neurotoxicity.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment, or have cardiac atrial or cardiac ventricular lymphoma involvement.\n* Subjects receiving anticoagulation therapy.\n* Any medical condition that in the judgement of the principal investigator is likely to interfere with assessment of safety or efficacy of study treatment\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n* Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the conditioning lymphodepletion chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.\n* In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n* May not have primary immunodeficiency or history of systemic autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.","2 Years","90 Years",{"count":124,"type":22},75,[25,26],"This is an open-label, single-arm, phase I clinical trial with dose escalation designed to investigate the safety, tolerability, and pharmacokinetic properties of Human CD19-CD22 Targeted T Cells Infusion. The primary objectives are to preliminarily assess the impact of Human CD19-CD22 Targeted T Cells Infusion in patients with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia and to explore the appropriate dose and reinfusion schedule for phase II.\n\nEligible participants, including those with Central Nervous System Lymphoma, B Cell Lymphoma (BCL), Acute Lymphocytic Leukemia (ALL), Acute Lymphoblastic Leukemia (ALL), B Acute Lymphoblastic Leukemia (B-ALL), Refractory Non-Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia (CLL), Refractory B Acute Lymphoblastic Leukemia (B-ALL), Diffuse Large B Cell Lymphoma, Lymphoid Leukemia, and MRD-positive cases, can participate. Eligibility will be determined through a comprehensive assessment, including disease evaluations, a physical examination, Electrocardiograph, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), and blood tests. Prior to the infusion of CD19-CD22 CAR+ T cells, participants will undergo chemotherapy. After the infusion, participants will be closely monitored for potential side effects and the effectiveness of CD19-CD22 CAR+ T cells. Certain study procedures may be conducted during hospitalization.",[128,129,130,131,132,133,134],"Acute Lymphoblastic Leukemia, Adult B-Cell","Acute Lymphoblastic Leukemia, in Relapse","Non-Hodgkin Lymphoma, B-cell","Diffuse Large B Cell Lymphoma","Central Nervous System Lymphoma","Lymphoma, Follicular","MCL",[132,136,137,138,131,139],"B Cell Lymphoma (BCL)","Acute Lymphocytic Leukemia (ALL)","Refractory Non-Hodgkin Lymphoma","MRD-positive cases","2025-08-05",{"date":142,"type":64},"2025-08-06",{"date":144,"type":64},"2024-07-10",{"date":146,"type":22},"2028-12-10",{"name":70,"class":71},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":156,"maxAge":122,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":159,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":72},"100598112","phase-1-sequential-cd146-and-gpc3-car-t-cell-therapy-in-advanced-ovarian-cancer-100598112","NCT07067255","Sequential CD146 and GPC3 CAR-T Cell Therapy in Advanced Ovarian Cancer","Phase 1\u002F2 Study of Sequential CD146 and GPC3 CAR-T Cell Therapy in Advanced Ovarian Cancer","BAH2573-104","Inclusion Criteria:\n\n* Expected survival time ≥3 months;\n* Diagnosis: Histologically or cytologically confirmed epithelial ovarian carcinoma (including fallopian tube or primary peritoneal carcinoma considered as ovarian cancer) that is relapsed or refractory to standard therapies. Patients must have received and progressed on or after at least one line of platinum-based chemotherapy (or be platinum-resistant) and have no curative standard treatment options.\n* Target Antigen Expression: Tumor must demonstrate positive expression of CD146 and GPC3 by immunohistochemistry (IHC) on a recent tumor tissue sample. Expression of both targets is required for eligibility (to ensure the presence of the CAR-T targets in the patient's cancer).\n* Disease Status: Measurable disease as defined by RECIST 1.1 criteria (at least one measurable lesion on imaging).\n* Age: Adults aged ≥18 years. (Patients must be legally adult and able to provide informed consent. Upper age limit may not be specified, but patients must meet other health criteria.)\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (indicative of fully active or restricted in physically strenuous activity only).\n* Organ Function: Adequate organ and bone marrow function, including: absolute neutrophil count (ANC) above a minimum threshold, platelet count above threshold, hemoglobin above threshold (transfusion allowed), serum AST\u002FALT and bilirubin ≤2× upper limit of normal (unless due to liver involvement by tumor), and adequate renal function (e.g. creatinine clearance ≥50 mL\u002Fmin or per protocol criteria).\n* Consent: Ability to understand and sign informed consent, and willing to comply with trial procedures and follow-up. Women of child-bearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a defined period after CAR-T cell infusion (due to unknown risks to a fetus).\n\nExclusion Criteria:\n\n* Prior Therapy: Previous treatment with any CAR-T cell therapy or other gene-engineered T-cell therapy targeting CD146 or GPC3. (Patients who received prior immunotherapies such as checkpoint inhibitors are allowed if a washout period is met, but prior CAR-T could confound results or pose increased risk.)\n* CNS Involvement: Active central nervous system (CNS) metastases or carcinomatous meningitis. (Patients with a history of CNS metastases that have been effectively treated and are radiographically stable off steroids may be eligible, per protocol specifics.)\n* Comorbid Illness: Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, clinically significant heart failure (e.g. NYHA Class III-IV), unstable angina or arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. (Patients with controlled chronic conditions may be eligible at the investigator's discretion.)\n* Immunosuppression: Active hepatitis B or C infection with viremia, or known HIV infection with uncontrolled viral load. Patients requiring chronic systemic immunosuppressive therapy (e.g. for an autoimmune condition or organ transplant) are excluded, except for physiologic dose steroids.\n* Pregnancy or Breastfeeding: Pregnant or breastfeeding women are excluded due to potential risks to the fetus or infant from the study treatment. Women of child-bearing potential who are unwilling or unable to use adequate contraception are not eligible.\n* Other Malignancy: Presence of another active malignancy requiring treatment (with the exception of certain early-stage cancers or those in remission for a specified period, per protocol). This is to avoid confounding outcomes and ensure patient safety.\n* Hypersensitivity: Known severe hypersensitivity to any component of the investigational CAR-T cell products or to the lymphodepletion chemotherapy drugs (cyclophosphamide, fludarabine).\n* Other Exclusions: Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study (such as life expectancy limited by comorbid illness, or significant laboratory abnormalities not covered above).","21 Years",{"count":158,"type":22},80,[25,26],"This is a multicenter, open-label Phase 1\u002F2 clinical trial evaluating the safety and preliminary efficacy of sequentially administered CD146-targeted and GPC3-targeted CAR-T cell therapy in patients with advanced relapsed or refractory ovarian cancer. Eligible patients will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by an infusion of autologous CD146-directed CAR-T cells (Arm A) and a subsequent infusion of autologous GPC3-directed CAR-T cells (Arm B). The Phase 1 portion will assess safety, tolerability, and dose-limiting toxicities (DLTs) to determine a recommended Phase 2 dose, while the Phase 2 portion will evaluate efficacy endpoints including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Patients will be followed for up to 36 months after CAR-T infusion to monitor long-term outcomes and adverse events.",[35,162,163,164],"Ovarian Carcinoma","Ovarian Sarcoma","Ovarian Cancer Stage IV",[166,167,168,47,35],"GPC3","CD146","CRISPR-Cas9","2025-07-05",{"date":171,"type":64},"2025-07-16",{"date":173,"type":64},"2025-04-29",{"date":175,"type":22},"2029-12-28",{"name":70,"class":71},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":156,"maxAge":122,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":193,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":200,"leadSponsor":201,"locationsCount":72},"100598092","phase-1-mesothelin-and-claudin-182-dual-target-car-t-therapy-in-advanced-pancreatic-cancer-100598092","NCT07066995","Mesothelin and Claudin 18.2 Dual-Target CAR-T Therapy in Advanced Pancreatic Cancer","Dual-Target Chimeric Antigen Receptor (CAR) T-Cell Therapy Directed Against Mesothelin and Claudin 18.2 in Patients With Advanced or Metastatic Pancreatic Cancer","BAH2573-102","Inclusion Criteria:\n\n* Expected survival time ≥3 months;\n* Histologically or cytologically confirmed pancreatic adenocarcinoma that is advanced (unresectable or metastatic). Patients should have received, or be intolerant of, standard first-line therapy (e.g., gemcitabine\u002Fnab-paclitaxel, FOLFIRINOX) for advanced disease. A short course of current first-line therapy is allowed for the purpose of bridging to manufacturing, but evidence of disease progression on or after at least one line is required prior to infusion (for the dose-expansion phase, patients must have progressed on ≥1 prior systemic regimen).\n* ECOG Performance Status: 0 or 1 (fully active or restricted in strenuous activity but ambulatory).\n* Liver and kidney function, cardiopulmonary function meet the following requirements:\n* Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;\n* Blood oxygen saturation \\>91% in non-oxygen state;\n* Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.\n* No serious mental disorders;\n* Can understand this test and has signed the informed consent.\n\nExclusion Criteria:\n\n* Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive;\n* Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;\n* Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;\n* Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;\n* Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion;\n* Patients who received CAR-T therapy or other gene-modified cell therapy before screening;\n* Participated in other clinical studies 1 month before screening;\n* Evidence of central nervous system invasion during subject screening;\n* Mental patients with depression or suicidal thoughts;\n* Situations considered unsuitable for inclusion by other researchers.",{"count":186,"type":22},60,[25,26],"Autologous T-cells engineered to express CARs targeting Mesothelin and Claudin18.2, for Unresectable locally advanced or metastatic pancreatic adenocarcinoma (Pancreatic Ductal Adenocarcinoma, PDAC), administered as two separate sequential infusions following lymphodepleting chemotherapy",[106,190,191,192],"Pancreatic Carcinoma","Pancreatic Cancer Non-resectable","Pancreatic Cancer Stage IV",[106,194,190,47,195],"claudin 18.2","Mesothelin","2025-07-04",{"date":198,"type":64},"2025-07-15",{"date":173,"type":64},{"date":68,"type":22},{"name":70,"class":71},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":156,"maxAge":122,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":222,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":228,"locationsCount":72},"100598091","phase-1-sequential-infusion-of-cd146-targeted-and-her2-targeted-car-t-cells-in-patients-with-advanced-sarcomas-100598091","NCT07066982","Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas","A Phase 1\u002F2 Open-Label, Multicenter Trial of Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas","BAH2573-103","Inclusion Criteria:\n\n* Expected survival time ≥3 months;\n* Diagnosis: Histologically or cytologically confirmed sarcoma (soft tissue or bone sarcoma), that is metastatic, locally advanced, or refractory to standard therapy. This may include osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, leiomyosarcoma, or other high-grade sarcomas. Patients must have evidence of measurable disease as per RECIST or applicable criteria.\n* Prior Treatment: Patients should have received and progressed on or not be candidates for standard first-line treatments. There is no limit on number of prior lines of therapy, but at least one prior systemic therapy for sarcoma is typically required (unless no standard therapy exists for the subtype). A minimum wash-out period (e.g. 2 weeks) from previous treatments (chemotherapy, radiation, or other immunotherapy) is required before lymphodepletion.\n* Age and Performance Status: Participants age 12 years and older (both adolescent and adult patients are eligible; for minors, legal guardian consent is required). Upper age limit of \\~75 years, or as determined by medical fitness. ECOG performance status 0-1 (or Karnofsky ≥70% for pediatric patients), indicating subjects are ambulatory and able to perform light work.\n* Organ Function: Adequate organ function to undergo cytotoxic chemotherapy and cell transfer therapy, including: cardiac ejection fraction ≥50%; baseline oxygen saturation \\>92% on room air; adequate bone marrow reserves (absolute neutrophil count ≥1.0×10\\^9\u002FL, platelets ≥75×10\\^9\u002FL, hemoglobin ≥8 g\u002FdL), hepatic function (e.g. bilirubin ≤1.5× ULN, AST\u002FALT ≤2.5× ULN), and renal function (e.g. creatinine clearance ≥50 mL\u002Fmin or age-appropriate normal).\n* Tumor Antigen Expression: Expression of CD146 and\u002For HER2 in the tumor is recommended (as assessed by immunohistochemistry or flow cytometry on a tumor sample). Note: At least one of the target antigens (CD146 or HER2) should be present on the tumor; if feasible, patients should have tumor tissue tested for these markers. (In cases where testing is unavailable, enrollment may proceed based on histology known to often express these targets, per investigator judgment.)\n* Consent: Ability to understand and provide written informed consent (or assent for minors with consent of legal guardian). Patients (or guardians) must be willing to comply with trial procedures and follow-up.\n\nExclusion Criteria:\n\n* Recent Therapies: Prior treatment with any CAR-T cell therapy or other gene-modified T-cell therapy is excluded. Also exclude patients who received any investigational drug, immunotherapy (e.g. checkpoint inhibitor), or major surgery within a certain interval (e.g. 4 weeks) prior to enrollment. Concurrent enrollment in another interventional clinical trial is not allowed.\n* Recent Therapies: Prior treatment with any CAR-T cell therapy or other gene-modified T-cell Infections: Active uncontrolled infection, including active hepatitis B or C infection, or HIV infection with uncontrolled viral load. Patients must not have evidence of active tuberculosis or other severe infections. All patients will be screened for HBV, HCV, and HIV at baseline.\n* Immunosuppression: Use of systemic immunosuppressive medications (such as chronic corticosteroids at \\>10 mg prednisone daily or equivalent) within 7 days prior to leukapheresis. (Physiologic replacement doses of steroids are permitted.) Patients with a history of allogeneic stem cell transplant or solid organ transplant are excluded (due to the need for immunosuppression and risk of graft-versus-host or graft rejection).\n* Medical Comorbidities: Any significant uncontrolled medical condition that would, in the investigator's judgment, make the patient an unsuitable candidate for CAR-T therapy. For example: active autoimmune diseases requiring immunosuppression, clinically significant heart failure (NYHA class III-IV), unstable angina or myocardial infarction within 6 months, severe chronic respiratory disease requiring supplemental oxygen, or psychiatric conditions that would interfere with study participation and follow-up.\n* Pregnancy\u002FBreastfeeding: Women who are pregnant or breastfeeding are excluded due to unknown risks of the treatment to a fetus or infant. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception during the study and for a suitable period after CAR-T infusion (e.g. 1 year), given the potential for sustained CAR T-cell activity. A negative serum pregnancy test is required for females of childbearing potential before starting lymphodepletion.",{"count":186,"type":22},[25,26],"This is an open-label, non-randomized, multicenter Phase 1\u002F2 trial evaluating a dual CAR-T cell therapy targeting CD146 and HER2 in patients with advanced sarcoma. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by sequential infusion of autologous CD146-specific and HER2-specific CAR-T cells. The Phase 1 portion will employ a dose-escalation design to assess safety and determine the recommended Phase 2 dose, while the Phase 2 expansion will evaluate preliminary efficacy (tumor response and survival outcomes). Approximately 40 patients (children and adults) with relapsed or refractory sarcomas will be enrolled across multiple centers. All participants will be followed for up to 36 months to monitor dose-limiting toxicities, objective response rates, progression-free survival, overall survival, and long-term safety.",[86,214,215,216,217,218,219,220,221],"Sarcoma, Kaposi","Sarcoma, Ewing","Sarcoma,Soft Tissue","Sarcoma of Bone and Connective Tissue","Sarcoma, Synovial","Sarcoma Metastatic","Sarcomas, Germinoblastic","Sarcoma of Bone",[86,167,223,47,221],"HER2",{"date":198,"type":64},{"date":226,"type":64},"2025-05-29",{"date":68,"type":22},{"name":70,"class":71},{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":156,"maxAge":122,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":244,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":254,"locationsCount":72},"100595413","phase-1-sequential-car-t-cells-targeting-bcmagprc5d-in-patients-with-relapsed-refractory-multiple-myeloma-100595413","NCT07032129","Sequential CAR-T Cells Targeting BCMA\u002FGPRC5D in Patients With Relapsed\u002F Refractory Multiple Myeloma","BAH2573","Inclusion Criteria:\n\n* Expected survival time ≥3 months;\n* Subjects with recurrent\u002Frefractory Multiple Myeloma who have failed standard treatment or lack effective treatment, Including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associated diseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.\n* Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.\n* Liver and kidney function, cardiopulmonary function meet the following requirements:\n* Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;\n* Blood oxygen saturation \\>91% in non-oxygen state;\n* Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.\n* No serious mental disorders;\n* Can understand this test and has signed the informed consent.\n\nExclusion Criteria:\n\n* Malignant tumors other than R\u002FR AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;\n* Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive;\n* Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;\n* Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;\n* Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;\n* Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion;\n* Patients who received CAR-T therapy or other gene-modified cell therapy before screening;\n* Participated in other clinical studies 1 month before screening;\n* Evidence of central nervous system invasion during subject screening;\n* Mental patients with depression or suicidal thoughts;\n* Situations considered unsuitable for inclusion by other researchers.",{"count":186,"type":22},[25,26],"This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or GPRC5D or both sequentially in the treatment of Relapsed\u002F Refractory Multiple myeloma",[240,241,242,243],"Multiple Myeloma","Multiple Myeloma in Relapse","Multiple Myeloma Progression","Multiple Myeloma, Refractory",[245,246,247,47,248],"Multiple myeloma","myeloma","Autoimmune Diseases","GPRC5D","2025-06-13",{"date":251,"type":64},"2025-06-22",{"date":173,"type":64},{"date":68,"type":22},{"name":70,"class":71},{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":17,"minAge":263,"maxAge":122,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":274,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":72},"100557029","phase-1-til-therapy-combined-with-pembrolizumab-for-advanced-or-metastatic-refractory-stomach-and-esophageal-cancer-100557029","NCT06532799","TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer","Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Pembrolizumab (Keytruda) Immunotherapy in Patients With Advanced or Metastatic Refractory Stomach and Esophageal Cancer","BAH250","Inclusion Criteria:\n\n* Age: 16 years to 90 years\n* Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized Cancer\n* Expected life span more than 3 months\n* Karnofsky≥60% or ECOG score 0-2\n* Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n* Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated\n* At least 1 evaluable tumor lesion\n* Hematology and Chemistry（within 7 days prior to enrollment）:\n* Absolute count of white blood cells≥2.5×10\\^9\u002FL\n* Absolute count of neutropils≥1.5×10\\^9\u002FL\n* Absolute count of lymphocytes ≥0.7×109\u002FL\n* Platelet count≥100×10\\^9\n* hemoglobin≥90 g\u002FL\n* Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin\n* Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN)\n* Totol bilirubin≤1.5×ULN\n* No absolute or relative contraindications to operation or biopsy\n* Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent and continue within 1 year after the completion of lymphodepletion\n* Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must cease 28 days before obtaining TILs\n* Be able to understand and sign the informed consent document;\n* Be able to stick to the follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n* Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment\n* Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%\n* Significant cardiovascular anomalies according to any of the following definitions:\n* New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant\n* Low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular conductive block, etc.\n* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive.\n* Severe physical or mental diseases;\n* Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection).\n* Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy.\n* History of allergy to chemical compounds consisting of chemical and biological substances resembling cell therapy.\n* Having received immunotherapy and developed an irAE level greater than Level 3.\n* Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded).\n* Females in pregnancy or lactation. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy.\n* Researchers consider the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.","16 Years",{"count":124,"type":22},[25,26],"This Phase I\u002FII study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory stomach and esophageal cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has shown significant promise in treating unresectable or metastatic melanoma by leveraging the patient's own immune cells to target and destroy cancer cells. This study aims to apply a similar approach to stomach and esophageal cancers. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody that targets the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.",[268,269,270,95,271,272,273],"Stomach Cancer","Stomach Cancer Recurrent","Stomach Cancer, Adenocarcinoma","Esophageal Cancer Metastatic to Bone","Esophageal Cancer Metastatic to Lung","Esophageal Cancer Metastatic to Liver",[275,47,276,277,278,279,280,281],"CAR-T Cell Therapy","Tumor Infiltrating Lymphocytes","Advanced or Metastatic Refractory","Immunotherapy","TIL","Biological Therapy","Pembrolizumab","2024-11-10",{"date":284,"type":64},"2024-11-12",{"date":286,"type":64},"2024-09-10",{"date":288,"type":22},"2026-12-28",{"name":70,"class":71},{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":17,"minAge":263,"maxAge":122,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":305,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":311,"locationsCount":72},"100557030","phase-1-til-gean-therapy-combined-with-immunotherapy-for-advanced-or-metastatic-refractory-breast-cancer-100557030","NCT06532812","TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer","Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Pembrolizumab (Keytruda) Immunotherapy in Patients With Advanced or Metastatic Refractory Breast Cancer","BAH249","Inclusion Criteria:\n\n* Age: 16 years to 90 years\n* Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized Breast Cancer\n* Expected life span more than 3 months\n* Karnofsky≥60% or ECOG score 0-2\n* Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n* Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated\n* At least 1 evaluable tumor lesion\n* Hematology and Chemistry（within 7 days prior to enrollment）:\n* Absolute count of white blood cells≥2.5×10\\^9\u002FL\n* Absolute count of neutropils≥1.5×10\\^9\u002FL\n* Absolute count of lymphocytes ≥0.7×109\u002FL\n* Platelet count≥100×10\\^9\n* hemoglobin≥90 g\u002FL\n* Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin\n* Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN)\n* Totol bilirubin≤1.5×ULN\n* No absolute or relative contraindications to operation or biopsy\n* Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent and continue within 1 year after the completion of lymphodepletion\n* Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must cease 28 days before obtaining TILs\n* Be able to understand and sign the informed consent document;\n* Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n* Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment\n* Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%\n* Significant cardiovascular anomalies according to any of the following definitions:\n* New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant\n* Low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular conductive block, etc.\n* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive.\n* Severe physical or mental diseases;\n* Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection).\n* Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy.\n* History of allergy to chemical compounds consisting of chemical and biological substances resembling cell therapy.\n* Having received immunotherapy and developed an irAE level greater than Level 3.\n* Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded).\n* Females in pregnancy or lactation. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy.\n* Researchers consider the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.",{"count":21,"type":22},[25,26],"This Phase I\u002FII study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory breast cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody that targets the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.",[30,302,303,304],"Breast Carcinoma","Breast Cancer Metastatic","Breast Cancer Triple Negative",[276,306,280,47,278,279],"CAR-T CELL",{"date":284,"type":64},{"date":309,"type":64},"2024-08-22",{"date":288,"type":22},{"name":70,"class":71},{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":17,"minAge":320,"maxAge":122,"enrollmentInfo":321,"targetDuration":4,"studyType":23,"phases":322,"briefSummary":323,"conditions":324,"keywords":329,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":335,"leadSponsor":336,"locationsCount":72},"100548366","phase-1-sequential-car-t-cells-targeting-cd33cd123-in-patients-with-acute-myelocytic-leukemia-aml-100548366","NCT06420063","Sequential CAR-T Cells Targeting CD33\u002FCD123 in Patients With Acute Myelocytic Leukemia AML","Sequential CAR-T Cell Infusion Targeting CD33 and CD123 for Refractory\u002FRelapsed Acute Myeloid Leukaemia","BAH244","Inclusion Criteria:\n\n* Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria:\n* Age older than 6 months.\n* Confirmed expression of CLL-1, CD123 and\u002For CD33 in blast AML by immuno-histochemical staining or flow cytometry.\n* Karnofsky performance status (KPS) score is higher than 80 and life expectancy \\> 3 months.\n* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg\u002FdL.\n* Hgb≥80g\u002FL.\n* No cell separation contraindications.\n* Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Severe illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n* Active bacterial, fungal or viral infection not controlled by adequate treatment.\n* Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n* Pregnant or nursing women may not participate.\n* Use of glucocorticoid for systemic therapy within one week prior to entering the trial.\n* Patients, in the opinion of investigators, may not be able to comply with the study.","6 Years",{"count":21,"type":22},[25,26],"This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD33 or CD123 or both sequentially in the treatment of Acute Myelocytic Leukemia.",[325,326,327,328],"AML","Acute Myeloid Leukemia","AML, Adult Recurrent","AML, Adult",[330,331,332,47],"aml","cd33","cd123",{"date":284,"type":64},{"date":144,"type":64},{"date":288,"type":22},{"name":70,"class":71},{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":122,"enrollmentInfo":345,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":347,"conditions":348,"keywords":355,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":361,"leadSponsor":362,"locationsCount":72},"100548367","phase-1-sequential-car-t-cells-therapy-for-cd5cd7-positive-t-cell-acute-lymphoblastic-leukemia-and-lymphoblastic-lymphoma-using-cd5cd7-specific-car-t-cells-100548367","NCT06420076","Sequential CAR-T Cells Therapy for CD5\u002FCD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5\u002FCD7-Specific CAR-T Cells","This is an Open, Single-arm, Clinical Study to Evaluate the Efficacy and Safety of Anti-CD7\u002FCD5 CAR-T Cells in the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL), ETP-ALL, and Lymphoblastic Lymphoma (TLBL).","BAH246","Inclusion Criteria:\n\n* Signed written informed consent; Patients volunteer to participate in the clinical trial;\n* Diagnosis is mainly based on the World Health Organization (WHO) 2008;\n* Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%;\n* Leukemic blast cells express CD7\u002FCD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%);\n* The expected survival period is greater than 12 weeks;\n* ECOG score ≤2;\n* Age 2-60 years old;\n* HGB≥70g\u002FL (can be transfused);\n* Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.\n\nExclusion Criteria:\n\n* Patients declining to consent for treatment\n* Prior solid organ transplantation\n* One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV;\n* History of severe pulmonary dysfunction diseases;\n* Severe infection or persistent infection cannot be effectively controlled;\n* Severe autoimmune disease or congenital immunodeficiency;\n* Active hepatitis;\n* Human immunodeficiency virus (HIV) infection;\n* Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).",{"count":186,"type":22},[25,26],"Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5\u002FCD7 in patients with patients with relapsed or refractory T-ALL\u002FLBL\u002FETP-ALL. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.",[349,350,351,352,353,354],"T Cell Lymphoma","T Cell Leukemia","T-cell Acute Lymphoblastic Leukemia","T-Cell Lymphoma of CNS","T Cell Prolymphocytic Leukemia","T Cell Childhood ALL",[47,356,357,358],"CD5","CD7","ETP-ALL",{"date":284,"type":64},{"date":144,"type":64},{"date":288,"type":22},{"name":70,"class":71},{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":17,"minAge":263,"maxAge":122,"enrollmentInfo":371,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":373,"conditions":374,"keywords":381,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":388,"locationsCount":72},"100565315","phase-1-til-therapy-combined-with-pembrolizumab-for-advanced-brain-cancer-including-gliomas-and-meningiomas-100565315","NCT06640582","TIL Therapy Combined With Pembrolizumab for Advanced Brain Cancer Including Gliomas and Meningiomas","Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Pembrolizumab Immunotherapy in Patients With Advanced Brain Cancer Including Gliomas and Meningiomas","BAH2472","Inclusion Criteria:\n\n* Age: 16 years to 90 years\n* Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized brain glioma\n* Expected life span more than 3 months\n* Karnofsky≥60% or ECOG score 0-2\n* Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n* Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated\n* At least 1 evaluable tumor lesion\n* Hematology and Chemistry（within 7 days prior to enrollment）:\n* Absolute count of white blood cells≥2.5×10\\^9\u002FL\n* Absolute count of neutropils≥1.5×10\\^9\u002FL\n* Absolute count of lymphocytes ≥0.7×109\u002FL\n* Platelet count≥100×10\\^9\n* hemoglobin≥90 g\u002FL\n* Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin\n* Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN)\n* Totol bilirubin≤1.5×ULN\n* No absolute or relative contraindications to operation or biopsy\n* Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent and continue within 1 year after the completion of lymphodepletion\n* Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must cease 28 days before obtaining TILs\n* Be able to understand and sign the informed consent document;\n* Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n* Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment\n* Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%\n* Significant cardiovascular anomalies according to any of the following definitions:\n* New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant\n* Low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular conductive block, etc.\n* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive.\n* Severe physical or mental diseases;\n* Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection).\n* Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy.\n* History of allergy to chemical compounds consisting of chemical and biological substances resembling cell therapy.\n* Having received immunotherapy and developed an irAE level greater than Level 3.\n* Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded).\n* Females in pregnancy or lactation. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy.\n* Researchers consider the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.",{"count":21,"type":22},[25,26],"This Phase I\u002FII study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with Advanced Brain Cancer including Gliomas and Meningiomas . Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to Brain cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to offer a novel, personalized treatment option for patients with limited therapeutic alternatives.",[375,376,377,378,379,36,380],"Brain Tumor","Brain Metastases","Brain Cancer","Glioma","Gliomas, Malignant","Meningioma",[276,306,280,277,278,279],"2024-11-04",{"date":384,"type":64},"2024-11-05",{"date":386,"type":64},"2024-10-20",{"date":288,"type":22},{"name":70,"class":71},{"id":390,"slug":391,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":17,"minAge":263,"maxAge":122,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":398,"briefSummary":399,"conditions":400,"keywords":403,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":408,"locationsCount":72},"100556837","phase-1-biological-tumor-infiltrating-lymphocytes-therapy-with-immunotherapy-for-colon-and-rectum-cancer-100556837","NCT06530303","Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer","Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Immunotherapy in Patients With Advanced or Metastatic Refractory Colon and Rectal Cancer (Colorectum)","BAH248","Inclusion Criteria:\n\n* Age: 16 years to 90 years\n* Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized Cancer\n* Expected life span more than 3 months\n* Karnofsky≥60% or ECOG score 0-2\n* Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n* Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated\n* At least 1 evaluable tumor lesion\n* Hematology and Chemistry（within 7 days prior to enrollment）:\n* Absolute count of white blood cells≥2.5×10\\^9\u002FL\n* Absolute count of neutropils≥1.5×10\\^9\u002FL\n* Absolute count of lymphocytes ≥0.7×109\u002FL\n* Platelet count≥100×10\\^9\n* hemoglobin≥90 g\u002FL\n* Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin\n* Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN)\n* Totol bilirubin≤1.5×ULN\n* No absolute or relative contraindications to operation or biopsy\n* Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent and continue within 1 year after the completion of lymphodepletion\n* Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must cease 28 days before obtaining TILs\n* Be able to understand and sign the informed consent document;\n* Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n* Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment\n* Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%\n* Significant cardiovascular anomalies according to any of the following definitions:\n* New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant\n* Low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular conductive block, etc.\n* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive.\n* Severe physical or mental diseases;\n* Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection).\n* Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy.\n* History of allergy to chemical compounds consisting of chemical and biological substances resembling cell therapy.\n* Having received immunotherapy and developed an irAE level greater than Level 3.\n* Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded).\n* Females in pregnancy or lactation. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy.\n* Researchers consider the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.",{"count":21,"type":22},[25,26],"This Phase I\u002FII study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) and Aldesleukin (interleukin-2, IL-2) immunotherapy in patients with advanced or metastatic refractory colon and rectal cancer (colorectum). TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response, while Aldesleukin will be used to further stimulate the TILs. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.",[90,401,402],"Colon Cancer","Rectum Cancer",[276,306,280,277,278,279],{"date":384,"type":64},{"date":406,"type":64},"2024-09-29",{"date":288,"type":22},{"name":70,"class":71},{"id":410,"slug":411,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":122,"enrollmentInfo":417,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":72},"100546758","phase-1-investigation-into-the-use-of-bah243-lentiviral-vector-for-gene-therapy-in-treating-sickle-cell-disease-100546758","NCT06399107","Investigation Into the Use of BAH243 Lentiviral Vector for Gene Therapy in Treating Sickle Cell Disease","Lentiviral Vector Gene Therapy in Sickle Cell Disease Using Autologous CD34+ Hematopoietic Stem Cells Collected Via Apheresis and Modified With a Lentiviral Vector","BAH243","Inclusion Criteria:\n\n* Have a diagnosis of SCD, with either βS\u002FβS, βS\u002Fβ0, or βS\u002Fβ+ genotype.\n* Be ≥2 and ≤50 years of age at time of consent.\n* Weigh a minimum of 6 kg.\n* Have a Karnofsky performance status of ≥60 (≥16 years of age) or a Lansky performance status of ≥60 (\\\u003C16 years of age).\n* Be treated and followed for at least the past 24 months prior to Informed Consent in medical center(s) that maintained detailed records on sickle cell disease history.\n* In the setting of appropriate supportive care measures (e.g., pain management plan), have experienced at least 4 protocol-defined VOEs in the 24 months prior to informed consent.\n* Have either experienced HU failure at any point in the past or must have intolerance to HU (intolerance is defined as the patient being unable to continue to take HU per PI judgment).\n* Female and male subjects of childbearing potential agree to use 1 method of highly effective contraception from Screening to at least 6 months after drug product infusion.\n* Provision of written informed consent for this study by subject, or as applicable, subject's parent(s)\u002Flegal guardian(s).\n\nExclusion Criteria:\n\n* Subjects for whom allogeneic hematopoietic stem cell transplantation (allo-HSCT) is medically appropriate per PI judgment and a willing, human leukocyte antigen (HLA)-matched related hematopoietic stem cell donor is available.\n* Severe cerebral vasculopathy, defined by any history of overt ischemic or hemorrhagic stroke, a history of abnormal transcranial Doppler (TCD) or TCD imaging (TCDI) for subjects ≤ 16 years of age (e.g. TCD velocity \\>200 cm\u002Fsec) requiring ongoing chronic transfusions, a Screening TCD or TCDI velocity \\> 200 cm\u002Fsec (central read), a Screening MRA showing \\> 50% stenosis or occlusion in the circle of Willis (central read), or a Screening MRA showing the presence of Moyamoya (central read).\n* Positive for presence of human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2), hepatitis B, hepatitis C, human T-lymphotropic virus-1 (HTLV-1), active syphilis.\n* Clinically significant, active bacterial, viral, fungal, or parasitic infection\n* Advanced liver disease, such as\n* clear evidence of liver cirrhosis, active hepatitis or significant fibrosis (based on MRI or liver biopsy)\n* liver iron concentration ≥15 mg\u002Fg unless liver biopsy shows no evidence of cirrhosis, active hepatitis or significant fibrosis\n* Inadequate bone marrow function, as defined by an absolute neutrophil count of \\\u003C1×10\\^9\u002FL (\\\u003C0.5×10\\^9\u002FL for subjects on hydroxyurea treatment) or a platelet count \\\u003C100×10\\^9\u002FL.\n* Any contraindications to the use of plerixafor during the mobilization of hematopoietic stem cells and any contraindications to the use of busulfan and any other medicinal products required during the myeloablative conditioning, including hypersensitivity to the active substances or to any of the excipients.\n* Patients needing therapeutic anticoagulation treatment during the period of conditioning through platelet engraftment\n* Unable to receive pRBC transfusion.\n* Prior receipt of an allogeneic transplant.\n* Prior receipt of gene therapy.\n* Any prior or current malignancy or immunodeficiency disorder, except previously treated, non-life threatening, cured tumors such as squamous cell carcinoma of the skin.\n* Immediate family member with a known or suspected Familial Cancer Syndrome.\n* Female subject is breastfeeding, pregnant or will attempt to become pregnant from Screening to at least 6 months after drug product infusion.\n* Any other condition that would render the subject ineligible for HSCT.\n* Participation in another clinical study with an investigational drug within 30 days of screening.\n* Presence of a chromosomal abnormality or genetic mutation that may put the subject at an increased risk of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) per Investigator's judgment.\n* Presence of genetic mutations that result in the inactivation of 2 or more α-globin genes",{"count":21,"type":22},[25,26],"This study is an open-label, non-randomized, single-dose Phase 1\u002F2 trial involving around 85 adult and pediatric participants aged between 2 and 50 years with sickle cell disease (SCD). It aims to assess the effectiveness of hematopoietic stem cell transplantation (HSCT) using BAH243 for SCD.",[421,422],"Sickle Cell Disease","Sickle-Cell Disease With Crisis",{"date":384,"type":64},{"date":425,"type":64},"2024-08-01",{"date":427,"type":22},"2025-12-28",{"name":70,"class":71},{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":17,"minAge":156,"maxAge":122,"enrollmentInfo":436,"targetDuration":4,"studyType":23,"phases":437,"briefSummary":438,"conditions":439,"keywords":443,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":448,"locationsCount":72},"100548991","phase-1-sequential-car-t-cells-targeting-bcmacd19-in-patients-with-relapsed-refractory-autoimmune-diseases-100548991","NCT06428188","Sequential CAR-T Cells Targeting BCMA\u002FCD19 in Patients With Relapsed\u002F Refractory Autoimmune Diseases","BAH247","Inclusion Criteria:\n\n* Expected survival time ≥3 months;\n* Subjects with recurrent\u002Frefractory autoimmune diseases who have failed standard treatment or lack effective treatment, Including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associated diseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.\n* Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.\n* Liver and kidney function, cardiopulmonary function meet the following requirements:\n* Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;\n* Blood oxygen saturation \\>91% in non-oxygen state;\n* Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.\n* No serious mental disorders;\n* Can understand this test and have signed the informed consent.\n\nExclusion Criteria:\n\n* Malignant tumors other than R\u002FR AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;\n* Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive;\n* Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;\n* Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;\n* Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;\n* Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion;\n* Patients who received CAR-T therapy or other gene-modified cell therapy before screening;\n* Participated in other clinical studies 1 month before screening;\n* Evidence of central nervous system invasion during subject screening;\n* Mental patients with depression or suicidal thoughts;\n* Situations considered unsuitable for inclusion by other researchers.",{"count":186,"type":22},[25,26],"This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or CD19 or both sequentially in the treatment of Relapsed\u002F Refractory Autoimmune Disease such as Sjogren's Syndrome or Systemic Lupus Erythematosus and other Autoimmune Disease.",[247,440,441,442],"Systemic Lupus Erythematosus","Systemic Lupus Erythematosus Acute","Sjogren's Syndrome",[442,440,247,47],{"date":384,"type":64},{"date":446,"type":64},"2024-05-29",{"date":288,"type":22},{"name":70,"class":71},{"id":450,"slug":451,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":369,"eligibilityCriteria":455,"healthyVolunteers":11,"sex":17,"minAge":263,"maxAge":122,"enrollmentInfo":456,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":464,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":471,"locationsCount":72},"100557430","phase-1-til-therapy-combined-with-pembrolizumab-for-advanced-or-metastatic-refractory-lung-cancer-100557430","NCT06538012","TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer","Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Pembrolizumab Immunotherapy in Patients With Advanced or Metastatic Refractory Lung Cancer","Inclusion Criteria:\n\n* Age: 16 years to 90 years\n* Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized Lung cancer\n* Expected life span more than 3 months\n* Karnofsky≥60% or ECOG score 0-2\n* Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n* Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated\n* At least 1 evaluable tumor lesion\n* Hematology and Chemistry（within 7 days prior to enrollment）:\n* Absolute count of white blood cells≥2.5×10\\^9\u002FL\n* Absolute count of neutropils≥1.5×10\\^9\u002FL\n* Absolute count of lymphocytes ≥0.7×109\u002FL\n* Platelet count≥100×10\\^9\n* hemoglobin≥90 g\u002FL\n* Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin\n* Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN)\n* Totol bilirubin≤1.5×ULN\n* No absolute or relative contraindications to operation or biopsy\n* Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent and continue within 1 year after the completion of lymphodepletion\n* Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must cease 28 days before obtaining TILs\n* Be able to understand and sign the informed consent document;\n* Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n* Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment\n* Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%\n* Significant cardiovascular anomalies according to any of the following definitions:\n* New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant\n* Low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular conductive block, etc.\n* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive.\n* Severe physical or mental diseases;\n* Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection).\n* Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy.\n* History of allergy to chemical compounds consisting of chemical and biological substances resembling cell therapy.\n* Having received immunotherapy and developed an irAE level greater than Level 3.\n* Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded).\n* Females in pregnancy or lactation. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy.\n* Researchers consider the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.",{"count":21,"type":22},[25,26],"This Phase I\u002FII study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory lung cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to lung cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to offer a novel, personalized treatment option for patients with limited therapeutic alternatives.",[460,461,462,463],"Lung Cancer","Lung Cancer Metastatic","Lung Cancer, Non-small Cell","Lung Cancer Recurrent",[276,306,280,277,278,279],"2024-10-11",{"date":467,"type":64},"2024-10-15",{"date":469,"type":64},"2024-08-20",{"date":288,"type":22},{"name":70,"class":71},{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":11,"sex":17,"minAge":480,"maxAge":122,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":491,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":494,"leadSponsor":495,"locationsCount":72},"100542995","phase-1-fourth-gen-car-t-cells-targeting-bcmacd19-for-refractory-systemic-lupus-erythematosus-sle-100542995","NCT06350110","Fourth-gen CAR T Cells Targeting BCMA\u002FCD19 for Refractory Systemic Lupus Erythematosus (SLE)","T-cell Infusion Targeting BCMA and CD19 for Refractory\u002FRelapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement","BAH242","Inclusion Criteria:\n\n* 18-90 years old;\n* Total score ≥ 10 on the EULAR\u002FACR 2019 SLE classification criteria.\n* SELENA-SLEDAI≥8.\n* Patients with CD19+ B-cell.\n* Hemoglobin≥85 g\u002FL.\n* WBC≥2.5×10\\^9\u002FL.\n* NEUT≥1×10\\^9\u002FL.\n* BPC≥50×10\\^9\u002FL.\n* AST\u002FALT below 2 times the upper limit of normal; Creatinine clearance ≥30 mL\u002Fmin; blood bilirubin ≤2.0 mg\u002Fdl; echocardiography indicates that the ejection fraction is ≥50%.\n* Adequate venous access for apheresis, and no other contraindications for leukapheresis.\n* Women of childbearing age should have a negative serum or urine pregnancy test at screening and baseline.\n* Subjects agree to take effective contraceptive measures during the trial until at least 1 year after CAR-T cells infusion.\n* Agree to attend follow-up visits as required.\n* Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative.\n\nExclusion Criteria:\n\n* Renal disease: severe lupus nephritis (serum creatinine \\> 2.5 mg\u002FdL or 221 μmol\u002FL) within 8 weeks --Prior to leukapheresis, or subjects who need hemodialysis.\n* CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident \\[CVA\\], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts.\n* Patients with serious lesions and a history of present illness of vital organs such as the heart, liver,kidney blood and endocrine system.\n* Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;\n* Received immunosuppressive therapy within 1 week prior to leukapheresis.\n* Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus.\n* Patients with syphilis infection.\n* The presence or suspicion of an active fungal, bacterial, viral or other infection that cannot be controlled during screening.\n* Received live vaccine treatment within 4 weeks prior to screening.\n* Severe allergies or hypersensitivity.\n* Contraindication to cyclophosphamide in combination with fludarabine.\n* Subjects who have undergone major surgery within 2 weeks prior to signing the informed consent form, or who are scheduled to have surgery (other than local anesthetic surgery) during the trial or within 2 weeks of the infusion.\n* Cannula or drainage tubes other than central venous catheters.\n* Pregnant or lactating women, or subjects who plan to have children within 1 year of treatment;\n* Subjects with prior CD19 or BCMA-targeted therapy.\n* Participated in any clinical study within 3 months prior to enrollment.\n* Subjects with malignant tumour, except for Non-melanoma Skin Cancer with PFS\\>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer.","18 Years",{"count":124,"type":22},[25,26],"This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.",[440,485,247,486,487,488,489,490,442],"Lupus Nephritis","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Granulomatous Polyangiitis","Microscopic Polyangiitis","Systemic Sclerosis","Idiopathic Inflammatory Myopathies",[275],{"date":467,"type":64},{"date":144,"type":64},{"date":427,"type":22},{"name":70,"class":71},""]