[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cho Pharma Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100512262","phase-1-a-study-to-assess-safety-and-efficacy-of-cho-h01-as-a-single-agentcombined-with-lenalidomide-in-subjects-with-refractory-or-relapsed-non-hodgkins-lymphoma-100512262",false,"NCT05950165","A Study to Assess Safety and Efficacy of CHO-H01 as a Single Agent\u002FCombined With Lenalidomide in Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma","A Phase I\u002FIIa, Open-label, Multicenter Study of the Safety and Efficacy of CHO-H01 as a Single Agent\u002FCombined With Lenalidomide to Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Life expectancy of \\>12 weeks.\n* Body mass index of 18 to 32 kg\u002Fm2.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Phase I: Have histologically (laboratory test) confirmed CD20 + non-Hodgkin's lymphoma according to the World Health Organization's 2016 classification:\n\n  1. Low grade lymphoma: follicular lymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma;\n  2. Other lymphoma: DLBCL (NOS: to include germinal center B-cell-like \\[GCB\\] and activated B-cell-like \\[ABC\\]), follicular lymphoma Grade 3b, mantle cell lymphoma; primary mediastinal large B-cell lymphoma.\n* Phase IIa: Histologically confirmed CD20 + non-Hodgkin's lymphoma according to the World Health Organization's 2016 classification, only low grade lymphoma: follicular lymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma.\n* Have at least one measurable lesion that is at least 1.5 cm in its largest dimension.\n* Off treatment for 30 days from last anti-CD20 infusion until planned administration of CHO-H01.\n* If no original sample is available, is willing and able to provide an adequate tumor biopsy sample at Screening.\n* Have adequate cardiac function: without clinically significant and\u002For uncontrolled heart disease.\n* Must be sterile, or have a monogamous partner who is surgically sterile, or at least 2 years postmenopausal, or be committed to use an acceptable form of birth control for the duration of the study (male), and for the duration of the study and for 3 months following the last CHO-H01 administration (female).\n\nExclusion Criteria:\n\n* Must not have a history of egg allergy or allergic reactions to any component of CHO-H01.\n* Must not have any known or current illnesses (such as autoimmune disease, unless well controlled or resolved), infection, or other condition that could limit study compliance or interfere with assessments.\n* Subjects who have received anti-programmed death-ligand 1 (PD-L1), programmed cell death 1 (PD-1), or cytotoxic T-lymphocyte associated protein 4 (CTLA-4) therapy.\n* Subjects who have completed an autologous stem cell transplant within 100 days prior to CHO-H01 therapy or an allogeneic stem cell transplant.\n* Subjects with known hepatitis B surface antigen (HBsAg) seropositive or known or suspected active hepatitis C infection with detectable viral load.\n* Subjects with known human immunodeficiency virus (HIV) infection\n* Subjects who have had radiation therapy, major surgical procedure or live vaccinations within 28 days prior to CHO-H01 administration.\n* Subjects with a history of type I hypersensitivity or anaphylactic reactions to murine proteins or to previous infusions of CD20 monoclonal antibodies.\n* Subjects who have received (or are receiving) systemic corticosteroids:\n\n  1. At a daily dose higher than 15 mg prednisone or equivalent within 14 days prior to the first administration of CHO-H01;\n  2. Topical, inhaled, nasal, and ophthalmic steroids are allowed.\n* Inadequate bone marrow, hepatic or renal function.\n* Subjects with a history of seizure disorder.\n* Subjects who are pregnant or breast feeding.\n* Subjects with any contraindications to lenalidomide (Only for phase IIa).","ALL","18 Years",{"count":19,"type":20},37,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a 2-part study. Part 1\u002FPhase 1 of the study will be conducted to determine the safety and tolerability of CHO-H01 in subjects with relapsed\u002Frefractory CD20+ non-Hodgkin's lymphoma. It will also determine maximum tolerated dose (MTD) and recommended phase II dose (RP2D).\n\nPart 2\u002FPhase 2a will assess the anticancer activity and safety of CHO-H01 plus lenalidomide in subjects with low-grade relapsed\u002Frefractory CD20+ non-Hodgkin's lymphoma.",[27],"Non-Hodgkin Lymphoma",[29,30,31,32,33],"CHO-H01","Anti-CD20 Antibodies","Large B-cell lymphoma","Follicular lymphoma","Glyco-engineered anti-CD20 antibody","RECRUITING","2026-03-01",{"date":37,"type":38},"2026-03-03","ACTUAL",{"date":40,"type":38},"2020-01-15",{"date":42,"type":20},"2026-12-23",{"name":44,"class":45},"Cho Pharma Inc.","INDUSTRY",9,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100596744","phase-1-study-of-cho-a04-in-advanced-solid-tumors-100596744","NCT07049458","Study of CHO-A04 in Advanced Solid Tumors","A Phase I\u002FIIa, Open-Label, Dose-Escalation and Cohort-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CHO-A04 in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. With either gender aged ≥ 18 years\n2. Histologically\u002Fcytologically confirmed, locally advanced unresectable or metastatic solid tumors\n3. Must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy\n4. Availability of archival tissue specimens for SSEA-4 immunohistochemistry (IHC) staining (optional for Phase I). Acceptable tumor tissues include:\n\n   1. Tumor tissue sample collected at the time of initial diagnosis\n   2. The most recent available recurrent\u002Fmetastatic tumor biopsy tissue is preferred if available (a pre-treatment biopsy is encouraged if the biopsy site is safely accessible) Note: This criterion is fulfilled if there is a qualified tumor sample (tumor cells were presented in the tumor biopsy tissue) and the tumor tissue slides can be obtained for IHC staining. It is not violated even if the staining result obtained after the screening visit reveals that the slides contain no identifiable tumor cells.\n5. Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2\n7. Has a life expectancy of at least 12 weeks in the opinion of the Investigator\n8. Has adequate hematopoietic function:\n\n   1. Absolute neutrophil count (ANC) ≥ 1500 cells\u002FμL without the need of myeloid growth factor support within 1 week\n   2. Platelet ≥ 90×103 counts\u002FμL without the need of platelet transfusion support within 1 week\n   3. Hemoglobin ≥ 9.0 g\u002FdL without the need of red blood cell (RBC) transfusion within 1 week\n9. Has adequate coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5× upper limit of the normal range (ULN)\n10. Has adequate liver function:\n\n    1. Total bilirubin ≤ 1.5× ULN and no signs of jaundice (≤ 3× ULN for subjects with known Gilbert disease)\n    2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN or ≤ 5.0× ULN in case of documented hepatic metastasis or hepatocellular carcinoma (HCC). For subjects with HCC, the Child-Pugh score must be ≤ 6\n11. Has adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m2) Note: eGFR (mL\u002Fmin\u002F1.73 m2) = 186.3 × (serum creatinine in mg\u002FdL)-1.154 × (age)-0.203× (0.742 if female) × (1.212 if African American\u002Fblack)\n12. Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions per Investigator's judgment\n13. Is able to understand the nature of this clinical study and accepts to enter the study by signing the informed consent form (ICF)\n\nExclusion Criteria:\n\n1. Has unresolved toxicities from prior anticancer therapy, defined as having not resolved to ≤ Grade 1 (NCI-CTCAE v5.0), except for alopecia and laboratory values listed in the inclusion criteria\n2. Has signs or symptoms of end-stage organ failure, major chronic illnesses other than cancer(s), or any severe concomitant conditions which, in the Investigator's opinion, make it undesirable for the subject to participate in the study, or could jeopardize compliance with the protocol\n3. History of another primary malignancy within the last 3 years (except for treated basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, or in situ cancer of the cervix) prior to the planned first infusion\n4. Has any significant cardiovascular or pulmonary diseases, including:\n\n   1. Poorly controlled hypertension (systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure ≥ 100 mm Hg)\n   2. Left ventricular ejection fraction (LVEF) \\\u003C 50% at the screening visit\n   3. Congestive heart failure (defined as New York Heart Association Class III or IV), myocarditis, myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, or coronary artery bypass graft within 24 weeks prior to the planned first infusion\n   4. Uncontrolled serious cardiac arrhythmias, such as ongoing clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes) Note: Sustained ventricular tachycardia is defined as tachycardia that continues for more than 30 seconds or leads to hemodynamic compromise within 30 seconds and requires intervention\n   5. Corrected QT interval (QTcF) \\> 480 ms demonstrated by at least two 12-lead ECGs \\> 30 minutes apart\n   6. Evidence of active pneumonitis (including drug-induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or history of idiopathic pulmonary fibrosis. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n   7. History of 2nd or 3rd-degree atrioventricular conduction defects\n5. History of thromboembolic or cerebrovascular events within the last 24 weeks before the screening visit, including transient ischemic attack, cerebrovascular accident, or deep vein thrombosis\n6. Has other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that would make the subject inappropriate for enrollment in this study in the opinion of the Investigator\n7. Has received anti-cancer therapies such as surgery on target lesions, chemotherapy, small molecule agent(s), hormone therapy, radiation therapy (except for palliative radiotherapy for bone metastasis of non-skeletal tumors), or any other anti-cancer agent(s) within 4 weeks or 5 half-lives of the treated agents, whichever is longer, prior to the first dosing. Has received prior anti-cancer monoclonal antibody therapy within 8 weeks prior to the first infusion.\n8. Has received systemic immunosuppressive medication(s) (including, but not limited to, steroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, tumor necrosis factor-ɑ antagonists, and calcineurin inhibitors) within 2 weeks (for those with a half-life ≤ 72 hours) or 4 weeks (for those half-life \\> 72 hours) prior to study dosing.\n\n   Note: For regular steroid use, ≤ 10 mg of prednisolone per day or equivalent is allowed. Inhaled or topical corticosteroids are allowed.\n9. Has participated in other clinical studies for investigational product(s) or medical device within 4 weeks or 5 half-lives (if known) prior to the planned first infusion, whichever is longer\n10. Has received cell therapy within 12 weeks prior to the planned first infusion\n11. Prior allogeneic hematopoietic stem cell, solid organ, or bone marrow transplantation(s)\n12. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n\n    Note: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the planned first infusion and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases. This exception does not include carcinomatous meningitis which is excluded regardless of its clinical stability\n13. Has symptomatic or poorly controlled pleural effusion, pericardial effusion, or ascites\n14. With the following infections:\n\n    1. History of active pulmonary tuberculosis infection ≤ 48 weeks prior to the planned first infusion, regardless of tuberculosis treatment\n    2. Any major episode of infection requiring treatment with systemic antibiotics or hospitalization within 4 weeks prior to the planned first infusion\n    3. Positive HBsAg; subjects with positive HBsAg test results can be considered as eligible if subjects can receive anti-HBV viral treatment(s), e.g., entecavir or tenofovir\n    4. Positive anti-HCV; subjects with positive for anti-HCV but with negative results for HCV viremia as shown by PCR are considered as eligible.\n    5. Medical history showing confirmed HIV-1 positivity\n15. Administration of a live, attenuated vaccine within 4 weeks prior to the planned first infusion or anticipation that such a live, attenuated vaccine will be required during the treatment period.\n16. With known or suspected hypersensitivity to any ingredients of investigational product\n17. History of severe allergic, anaphylactic, or other severe hypersensitivity reactions to therapeutic humanized antibodies\n18. Female subject who is breastfeeding, has a positive pregnancy test result at eligibility checking, or expecting to conceive or have children within the projected duration of the trial, starting from the screening visit through 90 days after the last dose of study treatment.\n19. All male subjects and female subjects with childbearing potential\\* (between puberty and 2 years after menopause) refuse to use at least two of appropriate contraception methods shown below from signing the ICF to at least 3 months after taking the last dose of study treatment.\n\n    1. Use oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example, hormone vaginal ring or transdermal hormone contraception.\n    2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).\n    3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n\n       * Male or female subjects who have undergone the following procedures are considered without childbearing potential.\n\n         * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 12 weeks before the screening visit. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.\n         * Male sterilization (24 weeks prior to the first infusion).",{"count":55,"type":20},62,[23,24],"The goal of this clinical trial is to learn if the study drug, CHO-A04, works to treat solid cancers in adults. It will also aim to learn about the safety of CHO-A04 and find the best dose to use in future cancer treatment. The main questions it aims to answer are:\n\n* Which dose of CHO-A04 shows the best anti-cancer ability?\n* How will your body respond to CHO-A04 treatment?\n* How long will CHO-A04 remain in your body?\n\nThere are two stages of investigation in this study:\n\n* Phase I: to find the best anti-cancer dose of CHO-A04\n* Phase IIa: to find the CHO-A04 anti-cancer ability in specific cancer types\n\nIn this study, each participant will be assigned to one of the CHO-A04 dose levels. Participants will have CHO-A04 infusion via blood vessel once every week for four weeks. The CHO-A04 treatment may continue based on participants' condition and CHO-A04 safety evaluations.",[59],"Advanced Solid Tumors",[61,62,63,64],"Advanced solid tumor","Anti-SSEA-4 antibody","Monoclonal antibody","Dose-escalation","NOT_YET_RECRUITING","2025-07-02",{"date":68,"type":38},"2025-07-03",{"date":70,"type":20},"2025-12-01",{"date":72,"type":20},"2028-10-01",{"name":44,"class":45},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":74},"100594185","phase-1-an-open-label-dose-finding-phase-i-study-to-evaluate-the-safety-and-immunogenicity-of-a-bivalent-klebsiella-pneumoniae-vaccine-cho-v08-in-healthy-adults-100594185","NCT07016152","An Open-label, Dose-finding, Phase I Study to Evaluate the Safety and Immunogenicity of a Bivalent Klebsiella Pneumoniae Vaccine (CHO-V08) in Healthy Adults","Inclusion Criteria:\n\n* Male or non-pregnant female, aged 18 to 50 years old (inclusive) for Cohorts 1 and 2 at the Screening visit.\n* Body mass index (BMI) of 18.0 to 30.0 kg\u002Fm2 (inclusive) at the Screening visit.\n* Physically and mentally capable of participating in the study and willing to adhere to study procedures.\n* Able to provide signed informed consent.\n* In generally good health by medical history, physical examination, vital signs, and clinical laboratory findings at the Screening visit based on the investigator's judgment.\n* Negative serology test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C antibody at the Screening visit.\n* Female subject with childbearing potential must have a negative result of pregnancy test at the Screening visit.\n* Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measure during the study period.\n* Male subject who agrees to use an adequate method of contraception during the study period.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition that, in the opinion of the investigator, may interfere with optimal participation in the study or place the subject at increased risk of AEs.\n* Suspected or known hypersensitivity (including allergy) to any of the vaccine components.\n* History of hypersensitivity or allergy to any vaccine, especially pneumococcal vaccine.\n* Current or previous, confirmed, or suspected disease caused by Klebsiella pneumoniae.\n* Medical conditions as a contraindication to the intramuscular vaccination and blood draws, e.g., coagulation disorder.\n* Any abnormality or permanent body art (e.g., tattoo) that would interfere with the observation of local reactions at the injection site (deltoid region).\n* Acute or chronic, clinically significant cardiovascular, pulmonary, hepatic or renal diseases and\u002For insufficiency as determined by physical examination or laboratory tests.\n* Known or suspected impairment of immunological function, e.g., asplenia\u002Fsplenectomy or history of autoimmune\u002Fimmune-mediated diseases or lymphoproliferative disorders.\n* Any screening laboratory abnormalities that are Grade 2 or above or deemed clinically significant in the opinion of the investigator.\n* Subjects with an electrocardiogram (ECG) at the Screening visit that demonstrates clinically relevant abnormalities which may affect subject safety or study results in the opinion of the investigator.\n* Positive test for SARS-CoV-2 virus at the Screening visit.\n* Use of any antibiotic therapy within 1 week prior to the first study vaccination.\n* History of any chronic or progressive disease that, according to judgment of the investigator, could interfere with the study outcomes or pose a threat to the subject's health.\n* History of cancer (except localized skin cancer without metastases) within 5 years prior to the Screening visit.\n* History or presence of heavy smoking (defined as \\> 10 cigarettes per day; approximately half pack per day) as documented in medical chart or by verbal confirmation at the Screening visit.\n* Documented history of substance or alcohol abuse in the medical chart or by verbal confirmation within 6 months prior to the Screening visit.\n* Received any vaccination (live, inactivated, or bacterial) within 1 month prior to the Screening visit and plans to receive vaccination within 4 weeks after the last study vaccination during the study period. Exception can be made with marketed vaccines against seasonal influenza or COVID-19 outside the 28-day window of the study vaccination.\n* Received major surgery or radiation therapy within 3 months prior to the Screening visit.\n* Onset of influenza-like illness as defined by: fever (temperature ≥ 38℃), dry cough, headache, fatigue, respiratory sputum production, dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat within 1 week prior to the Screening visit.\n* Female subject who is pregnant or lactating at the Screening visit or plans to be pregnant during the study period or lactate from the time of the first vaccination through 60 days after the last vaccination.\n* Received any investigational drug or device or have participated in a clinical study within 3 months prior to the Screening visit.\n* Any confirmed or suspected abnormal immune function, immunosuppression, or immunodeficiency or received any immunosuppressants (including systemic corticosteroids) or immunomodulators within 3 months prior to the Screening visit.\n* Had blood donation within 2 weeks prior to the Screening visit.\n* Received any blood products or immunoglobulin within 3 months prior to the Screening visit.",true,"50 Years",{"count":84,"type":20},40,[23],"CHO-V08 is currently being developed as a prevention vaccine against nosocomial and community-acquired infection caused by hypervirulent Klebsiella pneumoniae K1 and K2 serotypes. The goal of study (KLEBBI-001) is to evaluate the safety, reactogenicity, and immunogenicity of the preventive vaccine of CHO-V08 in healthy volunteers aged from 18 to 50 years old.",[88,89],"Klebsiella Pneumoniae Infection","Vaccine",[88,89],"2025-06-26",{"date":93,"type":38},"2025-06-27",{"date":91,"type":38},{"date":96,"type":20},"2027-04-10",{"name":44,"class":45},""]