[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ImmunityBio, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":390},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,45,86,103,127,146,178,201,223,242,263,288,308,327,347,372],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100570672","phase-2-a-phase-2-open-label-single-arm-study-of-autologous-m-cenk-adoptive-cell-therapy-and-n-803-il-15-superagonist-in-combination-with-gemcitabine-in-participants-with-recurrent-platinum-resistant-high-grade-ovarian-cancer-100570672",false,"NCT06710288","A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer","A Phase 2, Open-label, Single-arm Study Of Autologous Memory Cytokine Enriched Natural Killer (M-CENK) Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer","Inclusion Criteria:\n\n1. ≥18 years and \\\u003C85 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.\n3. Participants must be appropriate for single-agent therapy as the next line of therapy, as determined by the Investigator.\n4. Participants must have received prior treatment with bevacizumab.\n5. Confirmed diagnosis of platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal or fallopian tube. Platinum-resistant is defined as a relapse within 6 months of receiving 1 to 3 platinum-based chemotherapy regimens.\n6. Must have at least one lesion that meets the definition of measurable disease defined by RECIST v1.1 criteria.\n7. Must have received at least one but no more than three prior systemic lines of anticancer therapy and had progressive disease (PD) while receiving or immediately after receiving the previous therapy. Progression will be calculated from the date of the last administered dose of platinum based therapy to the date of radiographic imaging that showed evidence of progression.\n\n   * Participants who had received one line of platinum-based therapy must have received at least four cycles of their initial platinum-containing regimen, had a response (complete or partial), and then had PD between 3 and 6 months after their last dose.\n   * Participants who had previously received two or three lines of platinum-based therapy must have had PD while receiving the therapy or within 6 months after the last dose.\n8. Participants with germline or somatic BRCA1 or BRCA2 mutations must have received prior PARP inhibitor therapy as maintenance or treatment.\n9. Must have adequate peripheral venous access on both arms, or be willing to have temporary vascular access placed for apheresis collection, if deemed necessary by the Investigator.\n10. Must be able to sit or recline with limited movement for approximately 6 hours during apheresis procedure.\n11. Participants must have been previously tested for FRα. If the test result was positive, they must have been offered treatment with mirvetuximab soravtansine-gynx.\n12. Agreement to practice effective contraception for female participants of childbearing potential. Female participants of childbearing potential must agree to use effective contraception for up to 7 months after completion of study treatment. Effective contraception includes surgical sterilization (eg, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, diaphragm), intrauterine devices (IUDs), and hormonal therapy.\n13. Eastern cooperative oncology group (ECOG) performance status of ≤ 1.\n14. Major surgery must be completed and recovered at least 4 weeks prior to the first dose of study treatment.\n15. Participants must meet the following organ and marrow function as defined below:\n\n    * Absolute neutrophil count ≥ 1,000\u002Fmm3\n    * Platelets ≥ 100,000\u002Fmm3\n    * AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN\n    * Total bilirubin ≤1.5 × institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 × ULN)\n    * Albumin ≥ 3.0 g\u002FdL\n    * Serum creatinine ≤ 2.0 mg\u002FdL OR creatinine clearance ≥ 40 mL\u002Fmin\u002F1.73 m2 by Cockcroft-Gault Formula (Appendix C.1)\n    * Oxygen saturation: ≥ 90% on room air\n16. Participants with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n17. Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification (Appendix B.2). To be eligible for this trial, participants should be class 2B or better.\n18. Expected survival \\> 16 weeks.\n19. Stated willingness to comply with study procedures.\n20. Able to attend required study visits and return for adequate follow-up, as required by this protocol.\n\nAll inclusion criteria must be answered \"yes\" for a participant to participate in the trial.\n\nExclusion Criteria:\n\nIn order to participate in the study, participants must not meet any of the following criteria:\n\n1. Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low grade or borderline ovarian tumor.\n2. Distant metastasis outside of the abdominopelvic cavity (e.g., central nervous system, pulmonary, osseous, etc.).\n3. Have had anti-tumor chemotherapy or other investigational agents within 2 weeks prior to M-CENK cell infusion, or immunotherapy within 4 weeks prior, or those who have not recovered from adverse events due to agents administered more than two weeks prior. The intent of the language is to ensure that anti-tumor chemotherapy or other investigational agents are not administered to participants within the specified window since they can potentially affect M-CENK cell activity. Therefore, the washout period is defined by time from NK cell infusion and not patient enrollment. During eligibility confirmation from the study team is requested to confirm that according to the planned M-CENK cell dosing schedule, the washout period should be completed, based on each drug class.\n4. Current bowel obstruction, history of bowel obstruction, or high risk for bowel obstruction (in the opinion of the investigator).\n5. Poor oral intake requiring parenteral nutrition or dependence on intravenous fluids.\n6. Presence or history of ascites.\n7. Receiving any other investigational agents.\n8. Solid organ transplant (allograft) recipients.\n9. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study treatment with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other non-invasive or indolent malignancy, or cancers from which the patient has been disease-free for \\> 1 year after treatment with curative intent.\n10. Known hypersensitivity or anaphylaxis to sulfa-containing study medication(s).\n11. Known allergy to dimethyl sulfoxide (DMSO).\n12. Prior history of immune-related toxicity during immune therapy that resulted in permanent discontinuation of therapy (as recommended per product label or consensus guidelines) OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well-controlled on replacement hormones) are excluded.\n13. Autoimmune disease: history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[Wegener's granulomatosis\\]) and motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis). participants with Hashimoto thyroiditis are eligible.\n14. Systemic corticosteroid therapy (\\> 10 mg of prednisone or equivalent dose of systemic steroids for at least 4 weeks prior to NK cell infusion). The intent of this language is to ensure that systemic steroids are not administered to participants within the specified window since this can potentially affect NK cell activity. Therefore, the washout period is defined by time from NK cell infusion and not patient enrollment. During eligibility confirmation the study team is requested to confirm that according to the planned NK cell dosing schedule, the washout period should be completed.\n15. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n16. HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions with anti-retroviral agents used in this study. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n17. Active uncontrolled hepatitis B or C are ineligible as they are at high-risk of lethal treatment-related hepatotoxicity in the setting of marrow suppression. Known non-infectious pneumonitis or any history of interstitial lung disease.\n18. Receipt of a live vaccine within 30 days of start of study treatment. During eligibility confirmation the study team is requested to confirm that according to the planned NK cell dosing schedule, the washout period should be completed.\n\nAll exclusion criteria must be answered \"no\" for a participant to participate in the trial.","FEMALE","18 Years","85 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is phase 2 single arm study evaluating the safety and preliminary efficacy of M-CENK adoptive cell therapy and fixed dose of N-803 in combination with gemcitabine in participants with platinum-resistant high-grade ovarian cancer (HGOC).Up to 20 participants will receive M-CENK (IV) and N-803 (SC) in combination with gemcitabine (IV).\n\nParticipants will undergo an apheresis procedure for the collection of mononuclear cells (MNCs) at least 1 day prior to Cycle 1 for manufacturing of M-CENK. Starting in Cycle 1, participants will receive gemcitabine and starting in Cycle 2 they will also receive M-CENK and N-803, until no additional M-CENK is available or confirmed PD per iRECIST, unless the participant is potentially deriving benefit per Investigator's assessment.\n\nParticipants who complete the study treatment or discontinue study treatment will be followed for survival\u002Fdisease status every 12 weeks (± 2 weeks) for up to 12 months after the last study treatment or until death, lost to follow-up, or withdrawal of consent.",[27],"Platinum-resistant Ovarian Cancer",[29,30,31],"high grade ovarian cancer","M-CENK","N-803","RECRUITING","2026-06-29",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2024-11-06",{"date":40,"type":21},"2027-05",{"name":42,"class":43},"ImmunityBio, Inc.","INDUSTRY",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100639509","phase-2-phase-2-study-of-nai-hpv-vaccine-and-nab-paclitaxel-in-hpv-positive-oropharyngeal-cancer-followed-by-de-intensified-radiation-compared-with-standard-chemoradiation-100639509","NCT07628062","Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Followed by De-Intensified Radiation Compared With Standard Chemoradiation","Open-Label, Single-Arm Phase 2 Study Of Nogapendekin Alfa Inbakicept, PD-L1 T-HaNK, And Bevacizumab And Randomized Phase 2B Study Of Nogapendekin Alfa Inbakicept, Bevacizumab, And Tumor Treatment Fields With Or Without PD-L1 T-HaNK In Participants With Recurrent Or Progressive Glioblastoma","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histologically confirmed squamous cell carcinoma of the oropharynx that is HPV-positive (p16 immunohistochemistry positive and\u002For HPV DNA positive). Patients with cervical lymph node metastases from an unknown primary can be included if p16-positive and likely OPSCC origin.\n5. Locally advanced, stage III\u002FIV HPV-associated OPSCC that is a candidate for definitive chemoradiation. Specifically, tumors classified as T3 or T4 and\u002For node-positive disease (N2 or N3), without distant metastases (M0). Patients with very low-risk disease (e.g. T1-T2 N0-1) are excluded, as these might be handled with less intensive standard therapy or surgery rather than this trial approach.\n6. No prior definitive treatment for the current OPSCC. Patients must be treatment-naïve with respect to chemotherapy, radiation, or investigational therapy for this cancer. Prior diagnostic biopsy is allowed, but no prior curative surgery or radiation to the head and neck.\n7. Participants should be suitable for organ-preserving therapy (i.e., radiation) with no immediate need for surgical resection (the trial is non-surgical upfront).\n8. Must be willing to accept the randomized treatment assignment after the safety lead-in. During the initial safety phase, all participants receive experimental therapy; once randomization begins, patients and investigators will not choose the arm - it will be assigned by the randomization schedule. Enrolled patients should have no clear contraindication to either arm's therapy (for instance, a patient who absolutely cannot receive cisplatin due to allergy or comorbidity might not be suitable, since cisplatin is required in both arms). The inclusion\u002Fexclusion criteria are structured to ensure a homogeneous population suitable for both the experimental approach and SOC chemoradiation.\n9. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.\n10. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males. Per cisplatin prescribing information, female participants of child-bearing potential must agree to use effective contraception for up to 14 months and non-sterile male participants must agree to use a condom for up to 11 months after last dose of cisplatin. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and hormonal therapy.\n\nExclusion Criteria:\n\n1. HPV-negative or Non-OPSCC: Tumors that are p16-negative or not in the oropharynx are excluded.\n2. Any evidence of distant metastases (M1 disease) excludes the patient, since the trial is for curative-intent local\u002Fregional therapy.\n3. Previous radiation in the head\u002Fneck region or prior chemotherapy\u002Fimmunotherapy for this cancer disqualifies the patient. We require a clean baseline to assess our regimen.\n4. Active autoimmune disease or immunosuppression. The experimental arm includes immunotherapy (IL-15 receptor agonist and IBRX-042 vaccine), patients with active serious autoimmune disorders or those requiring immunosuppressive medications (e.g. chronic steroids \\>10 mg prednisone daily) are excluded to avoid severe immune-related complications. Well-controlled or mild autoimmune conditions may be considered on a case-by-case basis if risk is low.\n5. Inadequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to baseline:\n\n   1. Absolute neutrophil count (ANC) \\\u003C 1,500 cells\u002FμL without granulocyte colony-stimulating factor support\n   2. Platelet count \\\u003C 100,000\u002FμL without transfusion\n   3. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) \\> 2.5 × ULN, with the following exception:\n\n      Participants with documented liver metastases: AST and\u002For ALT \\> 5 × ULN\n   4. Serum bilirubin ≤ 3 × ULN\n   5. Creatinine clearance ≤ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n   6. Serum albumin \\\u003C 3.0 g\u002FdL.\n6. Significant cardiovascular disease (such as New York Heart Association cardiac disease class II or greater), myocardial infarction within 3 months prior to baseline, unstable arrhythmias, or unstable angina.\n7. Severe infections at the time of enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n8. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \\\u003C 350 cells\u002FμL and\u002For a detectable HIV viral load.\n9. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications.\n10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.\n11. Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to the start of treatment on this study.\n12. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n13. Pregnant and nursing women.","ALL",{"count":54,"type":21},70,[24],"This Phase 2a\u002F2 study evaluates the safety, tolerability, and efficacy of neoadjuvant and adjuvant NAI, hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel in participants with locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). The study includes a Phase 2a safety lead-in followed by a randomized Phase 2 comparison of a de-intensified experimental chemoradiation approach versus standard-of-care chemoradiation.",[58,59,60],"HPV-Positive Oropharyngeal Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Head and Neck Cancer",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"Locally Advanced HPV-Positive OPSCC","Human Papillomavirus-Associated Oropharyngeal Cancer","HPV-16","Squamous Cell Carcinoma of the Oropharynx","Chemoradiation","Cisplatin","Intensity-Modulated Radiation Therapy","De-Intensification Strategy","Neoadjuvant Therapy","Adjuvant Immunotherapy","hAd5 HPV Vaccine","ANKTIVA","Phase 2","NavDx","Head and Neck Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-01",{"date":80,"type":36},"2026-06-04",{"date":82,"type":21},"2026-07-22",{"date":84,"type":21},"2031-06-27",{"name":42,"class":43},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":92,"enrollmentInfo":4,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":101,"locationsCount":102},"100578349","resq132ex-nmibc-expanded-access-use-of-recombinant-bacillus-calmette-gurin-in-nonmuscle-invasive-bladder-cancer-100578349","NCT06810141","ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer","Participant Eligibility:\n\nWomen and men of all races and ethnic groups are eligible for this trial.\n\nInclusion Criteria and Contraindications:\n\nParticipants must meet the inclusion criteria and contraindications determined by the standards of their institution per the TICE BCG label. In BCG naïve subjects with NMIBC, enrollment should occur only if TICE BCG is unavailable.","100 Years","EXPANDED_ACCESS","This expanded access protocol is designed to provide Recombinant Mycobacterium BCG (rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible to receive TICE® BCG, may benefit from its use, and who are ineligible to participate in a clinical trial using rMBCG, or for other reasons cannot participate (eg, geographically unable to access a study site).",[96],"NMIBC","AVAILABLE","2026-05-13",{"date":100,"type":36},"2026-05-14",{"name":42,"class":43},66,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100602455","phase-2-a-study-to-examine-anktiva-for-the-treatment-of-covid-19-100602455","NCT07123727","A Study to Examine Anktiva for the Treatment of COVID-19.","Single Arm Study to Evaluate the Safety of Nogapendekin Alfa Inbakicept (NAI) in Participants With Long COVID","Inclusion Criteria:\n\n* Age ≥ 18 and \\\u003C 70 years.\n* History of at least one SARS-CoV-2 infection, defined as report of a positive nucleic acid amplification test (NAAT) and\u002For a positive SARS-CoV-2 antigen rapid diagnostic test (RDT). Those with only suspected but unconfirmed infections are not eligible for this study.\n* Clinical evidence of Long COVID, as confirmed by the Investigator's assessment.\n\n  1. At least 2 symptoms or at least 1 severe symptom as assessed by the study team (see list) that are new or worsened since the time of a SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the PI. At least 2 symptoms from those listed here must be present: systemic symptoms (eg, fatigue, chills, post-exertional malaise), neurocognitive symptoms (eg, trouble with memory\u002Fconcentration (\"brain fog\"), headache, dysautonomia\u002Fpostural orthostatic tachycardia symptoms, dizziness, unsteadiness, neuropathy, sleep disturbance), cardiopulmonary symptoms (eg, chest pain, palpitations, shortness of breath, cough, fainting spells), musculoskeletal symptoms (eg, muscle aches, joint pain), gastrointestinal symptoms (eg, nausea, diarrhea). Although other symptoms (eg, skin rash, hair loss, trouble with smell\u002Ftaste, genitourinary symptoms) will be recorded and tracked, at least 2 core symptoms listed above must be present. Note: the 2 symptoms can be from within the same category (for example, brain fog and headache) AND\n  2. Symptoms must have been present for at least 60 days prior to screening. Symptoms that wax and wane must have been initially present at least 60 days prior to screening AND\n  3. Symptoms must be reported to be at least somewhat bothersome and to have an impact on quality of life and\u002For everyday functioning AND\n  4. At least 90 days have elapsed since the most recent suspected or confirmed SARS-CoV-2 infection and the time of screening. Note: suspected infections will be determined based upon assessment by the study Investigators.\n* Not currently hospitalized.\n* Body mass index (BMI) 18 to 50 kilograms\u002Fmeter squared (kg\u002Fm2), inclusive, at the time of screening.\n* In otherwise stable health, as assessed by the Investigator within 28 days prior to screening, based on medical history, physical examination, laboratory findings, and vital signs.\n* For male participants,\n\n  a. Participants with partners that are WOCBP are strongly advised to inform their partners and must agree to use effective contraception from study entry (defined as INT1) through 7 months after the last dose of study intervention. Participants with pregnant partners must agree to use condoms during vaginal intercourse from study entry (defined as INT1) through 14 days after the last dose of study intervention administration.\n* For female participants,\n\n  a. A female participant who engages in sexual intercourse with male partners is eligible to participate if she is not pregnant or breastfeeding, and the following conditions applies: i. Is not a WOCBP OR ii. All of the following apply:\n  1. Is a WOCBP and is using a contraceptive method from - 21 days from study entry (defined as INT1), during the study intervention period, and for at least 7 months after the last study intervention administration.\n  2. A WOCBP must have a negative urine pregnancy test within 24 hours prior to all doses of study intervention. If a urine pregnancy test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test must be negative.\n* Willingness and ability to comply with the study protocol. This includes reliable transportation and sufficient time to attend all visits.\n* Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Previously received a SARS-CoV-2 antiviral or monoclonal antibody 30 days prior to planned INT1 or plan to receive such treatment before exiting the study.\n* Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2 within 14 days prior to plan to receive such treatment before exiting the study.\n* History of autoimmune disease including, but not limited, to celiac disease, rheumatoid arthritis, psoriasis, and inflammatory bowel diseases.\n* Active cardiovascular disease, defined as known prior:\n\n  1. Myocardial infarction within 90 days of screening; OR\n  2. Coronary artery bypass procedure within 90 days of screening; OR\n  3. Current heart failure with reduced ejection fraction (\\\u003C45%); OR\n  4. Current pulmonary arterial hypertension.\n* Known stroke within 3 months prior to planned INT1.\n* Known active bacterial, fungal, viral, or other infection besides SARS-CoV-2 requiring treatment within the 14 days prior to INT1 and meeting criteria for systemic involvement upon review by the PI.\n* Major surgery within 3 months prior to planned INT1 or planned major surgery during the first 75 days following planned INT1.\n* History of unplanned hospitalization for \\>24 hours within 28 days prior to Screening.\n* Active or prior Hepatitis B (Hep B) infection (defined as Hep B core antibody (cAb) and\u002For Hep B surface antigen (sAg) positive. Note: Prior hepatitis B is exclusionary even in the absence of ongoing infection.\n* Active Hepatitis C (Hep C) infection (defined as Hep C Ab positive or indeterminate with detectable Hep C RNA). Note: Those with cured Hep C (Ab positive or indeterminate but negative Hep C RNA) will remain eligible.\n* Laboratory abnormalities including:\n\n  1. ANC \\\u003C 1,500 per mm3\n  2. Platelet count \\\u003C100,000 per mm3\n  3. Hemoglobin \\\u003C 9 d\u002FdL\n  4. Baseline AST or ALT \\> 1.5 × ULN\n  5. CrCl \\\u003C 50 (estimated glomerular filtration rate)\n* Known or suspected HIV infection.\n* End stage kidney disease requiring dialysis.\n* History of Type I or Type 2 Diabetes mellitus requiring systemic medication or insulin.\n* Severe hepatic impairment (Child-Pugh Class C).\n* Moderate or severe immunocompromise, includes the following: (a) receiving active treatment for solid tumor or hematologic malignancy, including use of systemic chemotherapy for treatment of cancer within the year prior to screening, (b) prior solid-organ transplant with active immunosuppressive therapy, (c) CAR-T cell therapy or hematopoietic cell transplant, on immunosuppressive therapy or transplant within the prior 2 years, (d) primary immunodeficiency syndromes, advanced or untreated HIV infection (see above), (f) on active high-dose corticosteroids (ie, ≥ 20mg prednisone or equivalent daily per day for ≥ 2 weeks).\n* Known prior diagnosis of myalgic encephalomyelitis\u002Fchronic fatigue syndrome (ME\u002FCFS), preceding and not related to SARS-CoV-2 infection and not worsened since SARS-CoV-2 infection.\n* Known prior diagnosis of dysautonomia, preceding and not related to SARS-CoV-2 infection and not worsened since SARS-CoV-2 infection.\n* Known allergy to any components used in the formulation of the intervention.\n* History of anaphylaxis or similar significant allergic reaction to prescription or non-prescription drugs or food products. Similarly, the presence of severe atopic conditions as assessed by the PI represents a significant risk for allergic reaction.\n* Participation in a clinical trial with receipt of an investigational product within 28 days prior to planned INT1, except for exploratory PET imaging studies related to Long COVID.\n* Current alcohol or illicit drug use as determined by the Investigator to preclude participation.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.","70 Years",{"count":112,"type":21},40,[24],"This study will examine the safety and effectiveness of Anktiva in treating patients with Long COVID-19 which is defined as persistent symptoms of a COVID-19 infection that remain after the infection is over.",[116,117,118],"Long COVID","Long COVID Syndrome","Long Covid 19","2026-05-08",{"date":98,"type":36},{"date":122,"type":36},"2025-09-04",{"date":124,"type":21},"2026-07",{"name":42,"class":43},1,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":110,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":126},"100601249","phase-2-a-study-to-assess-anktiva-in-patients-with-long-covid-19-100601249","NCT07108036","A Study to Assess Anktiva in Patients With Long Covid-19.","Interleukin-15 Superagonist Nogapendekin Alfa Inbakicept in Participants With Long Covid.","INTERRUPT_LC","Inclusion Criteria:\n\n* Age ≥ 18 and \\\u003C 70 years.\n* Enrolled or willing to enroll and complete at least 1 visit in the UCSF Long-term Impact of Infection with Novel Coronavirus study. Any adult who has been infected with SARS-CoV-2 or has ever received or is eligible to receive a SARS-CoV-2 vaccination, and who is able to provide written informed consent, is eligible to participate in LIINC.\n* History of at least one SARS-CoV-2 infection, defined as report of a positive nucleic acid amplification test (NAAT) and\u002For a positive SARS-CoV-2 antigen rapid diagnostic test (RDT). Written proof of the test will be requested but is not required as long as the participant attests to the positive test. Those with only suspected but unconfirmed infections are not eligible for this study.\n* Clinical evidence of Long COVID, as confirmed by the Investigator's assessment.\n\n  1. At least 2 symptoms or at least 1 severe symptom as assessed by the study team (see list) that are new or worsened since the time of a SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the PI. At least 2 symptoms from those listed here must be present: systemic symptoms (eg, fatigue, chills, post-exertional malaise), neurocognitive symptoms (eg, trouble with memory\u002Fconcentration (\"brain fog\"), headache, dysautonomia\u002Fpostural orthostatic tachycardia symptoms, dizziness, unsteadiness, neuropathy, sleep disturbance), cardiopulmonary symptoms (eg, chest pain, palpitations, shortness of breath, cough, fainting spells), musculoskeletal symptoms (eg, muscle aches, joint pain), gastrointestinal symptoms (eg, nausea, diarrhea). Although other symptoms (eg, skin rash, hair loss, mental health symptoms, trouble with smell\u002Ftaste, genitourinary symptoms) will be recorded and tracked, at least 2 core symptoms listed above must be present. Note: the 2 symptoms can be from within the same category (for example, brain fog and headache) AND\n  2. Symptoms must have been present for at least 60 days prior to screening. Symptoms that wax and wane must have been initially present at least 60 days prior to screening AND\n  3. Symptoms must be reported to be at least somewhat bothersome and to have an impact on quality of life and\u002For everyday functioning AND\n  4. At least 90 days have elapsed since the most recent suspected or confirmed SARS-CoV-2 infection and the time of screening. Note: suspected infections will be determined based upon assessment by the study Investigators.\n* Not currently hospitalized.\n* Body mass index (BMI) 18 to 50 kilograms\u002Fmeter squared (kg\u002Fm2), inclusive, at the time of screening.\n* In otherwise stable health, as assessed by the Investigator within 28 days prior to screening, based on medical history, physical assessment, laboratory findings, and vital signs.\n* For male participants,\n\n  a. Participants with partners that are women of childbearing potential (WOCBP) are strongly advised to inform their partners and must agree to use effective contraception from study entry (defined as INT1) through 7 months after the last dose of study intervention. Effective methods of contraception are described in Appendix 2. Participants with pregnant partners must agree to use condoms during vaginal intercourse from study entry (defined as INT1) through 14 days after the last dose of study intervention administration. Participants assigned male sex at birth must agree to refrain from sperm donation from study entry through 14 days after the last dose of study intervention administration.\n* For female participants,\n\n  a. A female participant who engages in sexual intercourse with male partners is eligible to participate if she is not pregnant or breastfeeding, and the following conditions applies: i. Is not a WOCBP OR ii. All of the following apply:\n  1. Is a WOCBP and is using a contraceptive method that is effective as described in Appendix 1 from -21 days from study entry (defined as INT1), during the study intervention period, and for at least 7 months after the last study intervention administration. She must also agree not to donate her eggs (ova, oocytes) for the purpose of reproduction from study entry (defined as INT1), during the study intervention period, and for at least 7 months after the last study intervention administration.\n  2. A WOCBP must have a negative urine pregnancy test within 24 hours prior to all doses of study intervention. If a urine pregnancy test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test must be negative.\n* Willingness and ability to comply with the study protocol. This includes reliable transportation and sufficient time to attend all visits.\n* Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Previously received a SARS-CoV-2 antiviral or monoclonal antibody 30 days prior to planned INT1 or plan to receive such treatment before exiting the study.\n* Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2 within 14 days prior to planned INT1 or before FU2.5 following planned INT1.\n* History of autoimmune disease including, but not limited to, celiac disease, rheumatoid arthritis, psoriasis, and inflammatory bowel disease.\n* Active cardiovascular disease, defined as known prior:\n\n  1. Myocardial infarction within 90 days of screening; OR\n  2. Coronary artery bypass procedure within 90 days of screening; OR\n  3. Current heart failure with reduced ejection fraction (\\\u003C45%); OR\n  4. Current pulmonary arterial hypertension.\n* Known stroke within 3 months prior to planned INT1.\n* Known active bacterial, fungal, viral, or other infection besides SARS-CoV-2 requiring treatment within the 14 days prior to INT1 and meeting criteria for systemic involvement upon review by the PI. Note: Mild or limited infections such as uncomplicated urinary tract or yeast infections, sexually transmitted infections, and mild dermatophyte infections may be reviewed with the Safety Monitoring Committee chair but are not exclusionary.\n* Major surgery within 3 months prior to planned INT1 or planned major surgery during the first 75 days following planned INT1.\n* History of unplanned hospitalization for \\>24 hours within 28 days prior to Screening.\n* Active or prior Hepatitis B (Hep B) infection (defined as Hep B core antibody (cAb) and\u002For Hep B surface antigen (sAg) positive. Note: Prior hepatitis B is exclusionary even in the absence of ongoing infection.\n* Active Hepatitis C (Hep C) infection (defined as Hep C Ab positive or indeterminate with detectable Hep C RNA). Note: Those with cured Hep C (Ab positive or indeterminate but negative Hep C RNA) will remain eligible.\n* Laboratory abnormalities including:\n\n  1. ANC \\\u003C 1,500 per mm3\n  2. Platelet count \\\u003C100,000 per mm3\n  3. Baseline AST or ALT \\> 1.5 × ULN\n  4. Hemoglobin \\\u003C 9 d\u002FdL\n  5. CrCl \\\u003C 50 (estimated glomerular filtration rate)\n  6. ALC \\\u003C 1,000 per mm3\n* Known or suspected HIV infection.\n* End stage kidney disease requiring dialysis.\n* History of Type I or Type 2 Diabetes mellitus requiring systemic medication or insulin.\n* Severe hepatic impairment (Child-Pugh Class C).\n* Moderate or severe immunocompromise, according to the current National Institutes of Health (NIH) COVID-19 Treatment Guidelines as of March 6, 2023. The detailed list is in Appendix 2, and includes the following: (a) receiving active treatment for solid tumor or hematologic malignancy, including use of systemic chemotherapy for treatment of cancer within the year prior to screening, (b) prior solid-organ transplant with active immunosuppressive therapy, (c) CAR-T cell therapy or hematopoietic cell transplant, on immunosuppressive therapy or transplant within the prior 2 years, (d) primary immunodeficiency syndromes, advanced or untreated HIV infection (see above), (f) on active high-dose corticosteroids (ie, ≥ 20mg prednisone or equivalent daily per day for ≥ 2 weeks).\n* Known prior diagnosis of myalgic encephalomyelitis\u002Fchronic fatigue syndrome (ME\u002FCFS), preceding and not related to SARS-CoV-2 infection and not worsened since SARS-CoV-2 infection.\n* Known prior diagnosis of dysautonomia, preceding and not related to SARS-CoV-2 infection and not worsened since SARS-CoV-2 infection.\n* Known allergy to any components used in the formulation of the intervention.\n* History of anaphylaxis or similar significant allergic reaction to prescription or non-prescription drugs or food products. Similarly, presence of severe atopic conditions as assessed by the PI represents significant risk for allergic reaction.\n* Participation in a clinical trial with receipt of an investigational product within 28 days prior to planned INT1, with the exception of exploratory PET imaging studies related to Long COVID.\n* Current alcohol or illicit drug use as determined by the Investigator to preclude participation.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.",{"count":20,"type":21},[24],"This study will test the safety and tolerability of Anktiva in patients with Long Covid. Eligible patients will receive up to 2 doses of Anktiva and have follow-up exams and tests.",[116],{"date":140,"type":36},"2026-05-11",{"date":142,"type":36},"2025-11-14",{"date":144,"type":21},"2026-10",{"name":42,"class":43},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":163,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":4},"100639367","phase-2-nai-for-sepsis-with-persistent-lymphopenia-100639367","NCT07578558","NAI for Sepsis With Persistent Lymphopenia","Phase 2, Randomized, Open-Label Clinical Trial Evaluating Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care Alone in Critically Ill Adults With Sepsis and Persistent Lymphopenia","Inclusion Criteria:\n\n1. Age 18 years or older at the time of informed consent\n2. Admitted to the ICU with a diagnosis of sepsis as defined by Sepsis-3 criteria: life-threatening organ dysfunction caused by a dysregulated host response to infection, operationalized as a Sequential Organ Failure Assessment (SOFA) score increase of 2 or more points\n3. Documented persistent lymphopenia defined as ALC \\\u003C1,000 cells\u002FµL on at least two consecutive measurements within 72 hours of sepsis diagnosis (measurements must be separated by at least 12 hours)\n4. Prior initiation of appropriate antimicrobial therapy per institutional guidelines\n5. Ability to obtain written informed consent from the participant or legally authorized representative\n6. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males (for up to 7 months after completion of therapy)\n\nExclusion Criteria:\n\n1. Hematologic malignancies including leukemia, lymphoma, and myelodysplastic syndromes\n2. Prior CAR-T cell therapy or hematopoietic stem cell transplant (HSCT) within 3 months of screening\n3. Active cytokine release syndrome (CRS) at screening\n4. Current or recent (within 7 days) use of colony stimulating factors (G-CSF, GM-CSF)\n5. Lymphopenia attributable to chemotherapy, radiation therapy, or immunosuppressive medications administered within 30 days prior to screening\n6. High-dose immunosuppressive therapy (\\>0.5 mg\u002Fkg prednisone equivalent daily), excluding physiologic replacement and stress-dose hydrocortisone for septic shock\n7. Life expectancy less than 24 hours as assessed by the treating physician\n8. Active uncontrolled bleeding requiring \\>2 units of packed red blood cells in the preceding 24 hours\n9. Known HIV infection with CD4 count \\\u003C350 cells\u002FµL and detectable viral load\n10. Known active viral hepatitis (hepatitis B or C with detectable viral load)\n11. Advanced dementia or other conditions precluding meaningful participation\n12. Known hypersensitivity to any component of the investigational products\n13. Participation in another interventional trial with an investigational immunomodulatory agent within 30 days prior to screening\n14. Pregnant or breastfeeding",{"count":154,"type":21},50,[24],"This is a Phase 2, randomized, open-label study evaluating the safety and efficacy of nogapendekin alfa inbakicept (NAI, ANKTIVA®) in combination with standard of care versus standard of care alone in critically ill adults with sepsis and persistent lymphopenia. The study aims to determine whether NAI can improve 28-day mortality by addressing the immunosuppressive phase of sepsis characterized by persistent lymphopenia (absolute lymphocyte count \\\u003C1,000 cells\u002FµL). Participants will be randomized 1:1 to receive either NAI 1.2 mg subcutaneous injection on Days 3 (or earlier if ALC \\\u003C700 cells\u002FµL), Day 14, and potentially Day 21 if ALC remains \\\u003C1,000 cells\u002FµL, plus standard of care, or standard of care alone. The study will enroll approximately 50 participants (25 per arm) with persistent lymphopenia.",[158,159,160,161,162],"Sepsis","Septic Shock","Lymphopenia","Immunosuppression","Critical Illness",[158,164,165,161,166,167,31,73,168,169,170],"Septic shock","Persistent lymphopenia","IL-15 receptor agonist","Nogapendekin alfa inbakicept","Immune reconstitution","Critical care","ICU","2026-05-05",{"date":140,"type":36},{"date":174,"type":21},"2026-07-06",{"date":176,"type":21},"2027-10-04",{"name":42,"class":43},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100573409","phase-3-clinical-trial-of-n-803-plus-tislelizumab-or-prior-failed-immune-checkpoint-inhibitor-and-docetaxel-versus-docetaxel-monotherapy-in-participants-with-advanced-or-metastatic-non-small-cell-lung-cancer-who-have-acquired-resistance-to-immune-checkpoint-in-100573409","NCT06745908","Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In","Randomized, Two-Cohort, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy","Eligibility Criteria:\n\nWomen and men of all races and ethnic groups are eligible for this trial.\n\nCohort A\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.\n3. Pathologically confirmed stage IV NSCLC disease.\n4. Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease (approximately 6 months duration \\[± 2 weeks\\]). Participants who received anti-PD-1\u002Fanti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1\u002Fanti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1\u002Fanti-PD-L1 mAb in their immediate prior line of therapy to be eligible.\n5. Participants with AGA must have 1 or more documented AGA(s): EGFR, ROS1, neurotrophic tyrosine receptor kinase (NTRK), B rapidly accelerated fibrosarcoma (BRAF), mesenchymal epithelial transition (MET) exon 14 skipping, rearranged during transfection (RET), Kirsten Rat sarcoma (KRAS) and HER2.\n6. Participants with AGA must meet the following criteria for advanced or metastatic NSCLC. Participants who have been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved (and is standard of care) for the participant's genomic alteration at the time of screening:\n\n   1. Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior osimertinib.\n   2. Participants who received a targeted agent as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose or received at least one additional course of targeted therapy for the same genomic alteration (which may or may not be same agent used in the adjuvant setting) for relapsed\u002Fprogressive disease.\n   3. Participants who have been treated with a prior tyrosine kinase inhibitor (TKI) must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration, or the participant will not be allowed in the study.\n   4. Participants must also meet the inclusion criteria #4 listed above.\n7. ECOG performance status of 0 to 2.\n8. Measurable tumor lesions according to RECIST v1.1.\n9. Have a life expectancy of at least 3 months.\n10. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.\n11. Agreement to practice effective contraception for female participants of child-bearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative serum pregnancy test at screening and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive associated with inhibition of ovulation, or an intrauterine device \\[IUD\\]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 7 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 7 months post last dose of study drug.\n12. Participants with known HIV infection must be receiving anti retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to enrollment.\n\nExclusion Criteria:\n\n1. Systemic autoimmune disease currently requiring treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma). The participant must have been off treatment for 180 days.\n2. History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR), including, but not limited to Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis (SJS\u002FTEN), drug reaction with eosinophilia and systemic symptoms (DRESS), or dose-limiting immune-mediated reactions.\n3. History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.\n4. Participants with AGA of ALK.\n5. History of known active hepatitis B or C infection to be assessed within 6 months prior to enrollment using locally accepted standard of care measurements. (Resolved cases are allowed.)\n6. Active infection requiring antibiotic therapy.\n7. Have known active central nervous system (CNS) metastases, carcinomatous meningitis, and\u002For spinal cord compression.\n8. Body weight ≤ 40 kg at screening.\n9. Active treatment with CYP3A4 inhibitors.\n10. Received a live vaccine ≤ 4 weeks prior to the first dose of study drug(s).\n11. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).\n12. Participants with known history of severe hypersensitive reactions to docetaxel or to other drugs formulated with polysorbate 80.\n13. Had major surgery within 28 days prior to study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating Investigator.\n14. Inadequate organ function, evidenced by the following laboratory results:\n\n    1. Absolute lymphocyte count \\\u003C institutional lower limit of normal (LLN) (ie, participant should have a normal lymphocyte count to enroll in the study).\n    2. Absolute neutrophil count ≤ 1,500 cells\u002Fmm3.\n    3. Platelet count ≤ 100,000 cells\u002Fmm3.\n    4. Participants with documented Gilbert's syndrome are to be excluded if total bilirubin is ≥ 3 × upper limit of normal (ULN) or direct bilirubin is \\> ULN.\n    5. Aspartate aminotransferase (AST \\[serum glutamic-oxaloacetic transaminase; SGOT\\]) or alanine aminotransferase (ALT \\[serum glutamic pyruvic transaminase; SGPT\\]) \\> 1.5 × ULN.\n    6. Alkaline phosphatase (ALP) levels \\> 2.5 × ULN.\n    7. Hemoglobin \\\u003C 9.0 g\u002FdL.\n    8. Serum creatinine \\> 2.0 mg\u002FdL or 177 μmol\u002FL or creatinine clearance \\\u003C 40 mL\u002Fmin (using the Cockcroft-Gault formula below):\n\n    Female = \\[(140 - age in years) × weight in kg × 0.85\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\] Male = \\[(140 - age in years) × weight in kg × 1.00\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\]\n15. Have any of following:\n\n    1. Cirrhosis at a level of Child-Pugh B (or worse);\n    2. Cirrhosis (any degree) and a history of hepatic encephalopathy; or\n    3. Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.\n16. Participation in an investigational drug study within 21 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer. Participating in any other interventional clinical trial during active participation in this clinical trial is not allowed.\n17. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n18. Pregnant and nursing women.\n19. History of allergic reactions to tislelizumab.\n20. History of prior adverse reaction to immunotherapy that led to its permanent discontinuation.\n21. Confinement in an institution by order of a court or authority.\n\nCohort B\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.\n3. Pathologically confirmed stage IV NSCLC disease.\n4. Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease (approximately 6 months duration \\[± 2 weeks\\]). Participants who received anti-PD-1\u002Fanti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1\u002Fanti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1\u002Fanti-PD-L1 mAb in their immediate prior line of therapy to be eligible.\n5. Participants who receive an immune CPI as consolidation therapy after chemoradiation are eligible if they show progression or recurrence within 3 months of their last CPI and must have received at least 6 months of exactly 1 line of prior CPI therapy. If that CPI is not approved for advanced NSCLC, then an approved alternative CPI will be used.\n6. If participants are positive for actionable genomic alteration (AGA), defined as a genomic alteration which has at least 1 regional Health Authority-approved targeted therapy. Participants MUST have received at least 1 targeted therapy or 2 or more if multiple lines of targeted therapies are approved in the region. Thus, participants must have exhausted regional Health Authority-approved targeted therapies for their specific AGA for first- or second-line NSCLC, then have acquired resistance to immune checkpoint therapy to be eligible. Participants must meet inclusion criteria #4.\n7. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and have no evidence of new or enlarging brain metastases and also are off steroids 3 days prior to dosing with study medication. Stable brain metastases by this definition should be established prior to the first dose of study medication. Participants with asymptomatic brain metastases (ie, no neurological symptoms, no requirements for corticosteroids, and no lesion \\>1.5 cm) may participate but will require regular imaging of the brain as a site of disease.\n8. ECOG performance status of 0 to 2.\n9. Measurable tumor lesion(s) according to RECIST v1.1.\n10. Have a life expectancy of at least 3 months.\n11. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.\n12. Agreement to practice effective contraception for female participants of child-bearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative serum pregnancy test at screening and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive associated with inhibition of ovulation, or an intrauterine device \\[IUD\\]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 7 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 7 months post last dose of study drug.\n13. Participants with known HIV infection must be receiving antiretroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to enrollment.\n\nExclusion Criteria:\n\n1. Autoimmune disease currently requiring systemic treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma) except for autoimmune thyroiditis needing thyroid replacement and diabetes requiring insulin. The participant must have been off treatment for 60 days.\n2. History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR), including, but not limited to Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis (SJS\u002FTEN), drug reaction with eosinophilia and systemic symptoms (DRESS), or dose-limiting immune-mediated reactions.\n3. History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring active treatment with systemic steroids or other systemic therapy; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.\n4. Have an active or uncontrolled hepatitis B and\u002For hepatitis C infection and are positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis B surface antigen \\[HBsAg\\], anti-hepatitis B surface antibody \\[anti-HBs\\], anti-hepatitis B core antibody \\[anti-HBc\\], or hepatitis B virus \\[HBV\\] DNA), and\u002For hepatitis C infection (as per hepatitis C virus \\[HCV\\] RNA) within 28 days of randomization. Participants are eligible if they:\n\n   1. Have received hepatitis B vaccination with only anti-HBs positivity and no clinical signs of hepatitis.\n   2. Have HbsAg+ with HBV infection for more than 6 months (ie, chronic HBV infection) meeting the following conditions:\n\n   i. HBV DNA viral load \\\u003C 2,000 IU\u002FmL. ii. Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST\u002FALT \\\u003C 3 ULN that are not attributable to HBV infection.\n\n   iii. Start or maintain antiviral treatment if clinically indicated as per the Investigator.\n\n   c. Have been curatively treated for hepatitis.\n5. Active infection requiring systemic antibiotic therapy (antiviral therapy is allowed).\n6. Have known active central nervous system (CNS) metastases, carcinomatous meningitis, and\u002For spinal cord compression.\n7. Body weight ≤ 40 kg at screening.\n8. Received a live vaccine ≤ 4 weeks prior to the first dose of study drug(s).\n9. Known history of severe hypersensitive reactions to docetaxel or to other drugs formulated with polysorbate 80.\n10. Had major surgery, myocardial infarction, and\u002For cerebrovascular accident within 28 days prior to study randomization. Participants must have fully recovered from the effects of prior surgery or illness in the opinion of the treating Investigator.\n11. Inadequate organ function, evidenced by the following laboratory results:\n\n    1. Absolute lymphocyte count \\\u003C institutional LLN (ie, participant should have a normal lymphocyte count to enroll in the study).\n    2. Absolute neutrophil count ≤ 1,500 cells\u002Fmm3.\n    3. Platelet count ≤100,000 cells\u002Fmm3.\n    4. Total bilirubin \\> 1.5 times the ULN, unless the participant has documented Gilbert's syndrome). Participants with documented Gilbert's syndrome are to be excluded if total bilirubin is ≥ 3 × ULN or direct bilirubin is \\> ULN.\n    5. Aspartate aminotransferase (AST \\[serum glutamic-oxaloacetic transaminase; SGOT\\]) or alanine aminotransferase (ALT \\[serum glutamic pyruvic transaminase; SGPT\\]) \\> 1.5 × ULN or \\> 5 times ULN for participants with liver metastases.\n    6. Alkaline phosphatase (ALP) levels \\> 2.5 × ULN, \\> 5 times ULN for participants with known bone metastases.\n    7. Hemoglobin \\\u003C 9.0 g\u002FdL.\n    8. Creatinine clearance \\\u003C 40 mL\u002Fmin (using the Cockcroft-Gault formula below):\n\n    Female = \\[(140 - age in years) × weight in kg × 0.85\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\] Male = \\[(140 - age in years) × weight in kg × 1.00\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\]\n12. Have any of the following:\n\n    1. Cirrhosis at a level of Child-Pugh B (or worse);\n    2. Cirrhosis (any degree) and a history of hepatic encephalopathy; or\n    3. Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.\n13. Participation in an investigational drug study within 28 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer. Participating in any other interventional clinical trial during active participation in this clinical trial is not allowed.\n14. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n15. Pregnant and nursing women.\n16. History of prior adverse reaction to immunotherapy that led to its permanent discontinuation.\n17. Have a history of malignancy other than NSCLC, except:\n\n    1. Adequately resected non-melanoma skin cancer; or,\n    2. Curatively treated in situ disease or\n    3. Other curatively treated solid tumors, with no evidence of disease for ≥ 3 years; or\n    4. Hormone sensitive cancers treated only with hormone therapy.\n18. Other antineoplastic therapies intended to treat cancer, including herbal medicines or other prohibited concurrent medication(s) within 28 days prior to the start of treatment in the study.\n19. Confinement in an institution by order of a court or authority.","90 Years",{"count":187,"type":21},507,[189],"PHASE3","This is a randomized, two-cohort, open-label, phase 3, clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (cohort A) or prior failed Health Authority-approved antiprogrammed death-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) CPI and docetaxel (cohort B) versus docetaxel monotherapy (cohorts A and B).\n\nFor each cohort, enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. For cohort A, the randomization will be stratified by geographical region (North America vs Europe vs Asia vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA) (epidermal growth factor receptor \\[EGFR\\]\u002Fanaplastic lymphoma kinase \\[ALK\\]\u002FROS proto-oncogene 1, receptor tyrosine kinase \\[ROS1\\] vs Other AGA vs No AGA).\n\nFor cohort B, the randomization will be stratified by geographical region (Americas vs Asia Pacific \\[PAC\\] vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA) (Yes vs No).",[192],"NSCLC Stage IV","2026-04-30",{"date":171,"type":36},{"date":196,"type":36},"2025-10-01",{"date":198,"type":21},"2029-01",{"name":42,"class":43},19,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":220,"leadSponsor":222,"locationsCount":4},"100630531","phase-1-open-label-phase-1-clinical-trial-of-neoadjuvant-nogapendekin-alfa-inbakicept-sotevtamab-and-zabadinostat-in-combination-with-gemcitabine-and-nab-paclitaxel-for-participants-with-borderline-resectable-or-locally-advanced-pancreatic-cancer-100630531","NCT07488884","Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combination With Gemcitabine and Nab-Paclitaxel for Participants With Borderline Resectable or Locally Advanced Pancreatic Cancer","ResQ108B-PANC","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n4. Histologically or cytologically confirmed PDAC that is confined to the pancreas.\n5. Borderline resectable (surgical resection possible but challenging) or locally advanced (surgical resection not possible) PDAC, as determined by the local investigator based onlocal institutional guidelines.\n6. Measurable tumor lesions according to RECIST v1.1. (within 90 days prior to first dose of study treatment).\n7. Have not received prior anticancer therapy for pancreatic cancer.\n8. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.\n9. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males. Female participants of child-bearing potential must agree to use effective contraception for up to 7 months after completion of therapy, and nonsterile male participants must agree to use a condom for up to 7 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and hormonal therapy.\n\nExclusion Criteria:\n\n1. Resectable PDAC, meeting the following criteria upon CT\u002FMRI: (a)No superior mesenteric vein (SMV) or portal vein (PV) distortion; (b) Clear fat planes around superior mesenteric artery (SMA), celiac artery (CA), and common hepatic artery (CHA).\n2. Participants for whom an operation is not considered in the participant's best interest (eg, due to comorbidity).\n3. Histologically or cytologically confirmed pancreatic tumor that is not adenocarcinoma.\n4. CA19-9 \\> 1,000 U\u002FmL.\n5. QTc interval using Fridericia's formula (QTcF) \\> 470 ms.\n6. If participants have had major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n7. Have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed.\n8. Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n9. Inadequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to baseline: (a) Absolute neutrophil count (ANC) \\\u003C 1,500 cells\u002FμL without granulocyte colonystimulating factor support, (b) Lymphocyte count \\\u003C 500\u002FμL, (c) platelet count \\\u003C 100,000\u002FμL without transfusion (d) Hemoglobin \\\u003C 8.0 g\u002FdL Note: Participants may be transfused to meet this criterion, (e) International Normalized Ratio (INR) or aPTT activated partial thromboplastin time (aPTT) \\\u003C 1.5 × upper limit of normal (ULN) Note: This applies only to participants who are not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose. (f) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \\> 2.5 × ULN, with the following exception: Participants with documented liver metastases: AST and\u002For ALT \\> 5 × ULN. (g) Serum bilirubin ≤ 3 × ULN (h) Creatinine clearance ≤ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula), (i) Serum albumin ≤ 3.0 g\u002FdL. (j) Urine dipstick for proteinuria \\> 2+ (within 7 days prior to initiation of study treatment). Participants with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate \\\u003C 1 g of protein in 24 hours.\n10. Significant cardiovascular disease (such as New York Heart Association cardiac disease class II or greater), myocardial infarction within 3 months prior to baseline, unstable arrhythmias, or unstable angina.\n11. Severe infections at the time of enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n12. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Participants receiving prophylactic antibiotics (eg, to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n13. Prior allogeneic bone marrow transplantation or solid organ transplant.\n14. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications.\n15. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.\n16. Treatment with systemic immunosuppressive medications (including, but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[anti-TNF\\] agents) within 2 weeks prior to initiation of study treatment, or anticipation of the need for systemic immunosuppressive medication during study treatment, with the following exceptions: (a) A. Participants who have received acute, low-dose, systemic immunosuppressant medications (eg, a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the Medical Monitor, (b)B. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (eg, fludrocortisone) for participants with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.\n17. Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to the start of treatment on this study.\n18. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n19. Pregnant and nursing women.",{"count":209,"type":21},30,[211],"PHASE1","This is an open-label, phase 1 clinical trial to evaluate the safety and preliminary efficacy of neoadjuvant chemoimmunotherapy (NAI, sotevtamab, and zabadinostat in combination with gemcitabine and nab-paclitaxel) followed by resection and adjuvant immunotherapy for participants with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC). Eligible participants will undergo endoscopic ultrasound (EUS)-guided biopsies of the primary pancreatic tumor within 7 days of enrollment and prior to study day 1. EUS-guided biopsies will be used for histopathological examination to give clinical diagnostic information (as SoC) and will be stored in an ethically approved tissue bank.",[214,215],"Pancreatic Cancer Resectable","Pancreatic Cancer","2026-04-28",{"date":218,"type":36},"2026-04-29",{"date":78,"type":21},{"date":221,"type":21},"2029-06-01",{"name":42,"class":43},{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":44},"100602619","phase-2-study-of-relapsed-refractory-b-cell-non--hodgkin-lymphoma-100602619","NCT07125872","Study of Relapsed\u002F Refractory B-cell Non- Hodgkin Lymphoma","Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination With Rituximab in Participants With Relapsed\u002F Refractory B-cell Non- Hodgkin Lymphoma","Inclusion Criteria:\n\n* 1- Age\\>18 years old 2- Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee( HRECC) or independent Ethics Committee( IEC) guidelines 3. Histologically or flow cytometry documented B-cell NHL, (excluding primary central nervous system \\[CNS\\] lymphoma, chronic lymphocytic leukemia \\[CLL\\], and Burkitt lymphoma) with the following specific criteria:\n\n  * Have completed ≥2 lines of cytotoxic chemotherapy.\n  * Have received rituximab or another anti-CD20 antibody.\n  * Have measurable disease by Lugano classification documented within 8 weeks of the time of consent, defined as nodal lesions \\>15 mm in the long axis or extranodal lesions \\>10 mm in long and short axis, or bone marrow involvement that is biopsy proven.\n\n    4\\. Eastern Cooperative Oncology Group (ECOG) performance status (Appendix 5) of 0 to 1.\n\n    5\\. Stated willingness to comply with study procedures. 6. Able to attend required study visits and return for adequate follow-up, as required by this protocol.\n\n    7\\. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential must agree to use effective contraception while on study and for at least 30 days after the last dose of study drug. Nonsterile male participants must agree to use a condom while on study and for up to 30 days after the last dose of study drug. Effective contraception includes orals, injectables, surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) and implants such as intrauterine devices (IUDs).\n\nExclusion Criteria:\n\n* Participants with ANY of the following criteria are excluded from participation in the study:\n\n  1. Histologically documented primary CNS lymphoma, CLL, Burkitt, Burkitt-like lymphoma.\n  2. Known hypersensitivity or allergy to any component of the study medications, including sulfa-containing study medication(s) (e.g., albumin \\[human\\], dimethyl sulfoxide \\[DMSO\\]).\n  3. Inadequate organ function, evidenced by the following laboratory results:\n\n     1. ANC \\\u003C 1000 cells\u002Fmm3.\n     2. Platelet count \\\u003C 100,000 cells\u002Fmm3.\n     3. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome or indirect hyperbilirubinemia).\n     4. Aspartate aminotransferase (AST \\[SGOT\\])\u002FALT (SGPT) ≥ 2.5 × ULN.\n     5. Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases).\n     6. Serum creatinine ≥ 160 µmol\u002FL. NOTE: Each study site should use its institutional ULN to determine eligibility.\n  4. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment-related complications.\n  5. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as \\> 20 mg of prednisone or equivalent daily.\n  6. History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.\n  7. Anti-CD20 antibody treatment less than 2 weeks prior to cell infusion.\n  8. History of receiving allograft organ transplant requiring immunosuppression.\n  9. Participants post solid organ transplants who develop high grade lymphomas or leukemias.\n  10. Metastases to the CNS, including parenchyma or leptomeninges.\n  11. Nonmalignant CNS disease (e.g., stroke, epilepsy, vasculitis, or neurodegenerative disease).\n  12. History of active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n  13. Uncontrolled hypertension (systolic \\> 160 mm Hg and\u002For diastolic \\> 110 mm Hg) or clinically significant (i.e., active) cardiovascular disease, cerebrovascular accident\u002Fstroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association (Appendix 6) Class 2 or higher; or serious cardiac arrhythmia requiring medication.\n  14. Current chronic daily treatment (continuous for \\>3 months) with systemiccorticosteroids as defined as \\>20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed.\n  15. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.\n  16. Tested positive for tuberculosis (TB) utilizing the QuantiFERON Gold TB test.\n  17. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \\\u003C 350 cells\u002FμL and a detectable HIV viral load.\n  18. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.\n  19. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n  20. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n  21. Women who are pregnant or breastfeeding.",{"count":20,"type":21},[24],"Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination with Rituximab in subjects with Relapsed\u002F Refractory B-cell Non- Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment.",[234],"Relapsed B-Cell Non Hodgkin Lymphoma",{"date":236,"type":36},"2026-05-04",{"date":238,"type":36},"2025-11-11",{"date":240,"type":21},"2028-05-25",{"name":42,"class":43},{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},"100541832","phase-1-study-for-subjects-with-relapsedrefractory-non-hodgkin-lymphoma-100541832","NCT06334991","Study for Subjects With Relapsed\u002FRefractory Non-Hodgkin Lymphoma","Open-Label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With Rituximab in Subjects With Selected CD19+ and CD20+ Relapsed\u002FRefractory B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee (HREC) or Independent Ethics Committee (IEC) guidelines.\n3. Histologically documented CD19- and CD20-positive B-cell NHL (excluding primary CNS lymphoma, CLL, and Burkitt lymphoma) with the following specific criteria:\n\n   1. Have completed ≥ 2 lines of cytotoxic chemotherapy.\n   2. Have received rituximab or another anti-CD20 antibody.\n   3. Have measurable disease by Lugano classification documented within 8 weeks of the time of consent, defined as nodal lesions \\> 15 mm in the long axis or extranodal lesions \\> 10 mm in long and short axis, or bone marrow involvement that is biopsy proven.\n   4. Have CD19- and CD20-positive disease confirmed on the diagnostic or repeat biopsy specimen. A minimum of 5% CD19 and CD20 positivity by immunohistochemistry or flow cytometry is required.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n5. Expected survival \\> 16 weeks.\n6. Stated willingness to comply with study procedures.\n7. Able to attend required study visits and return for adequate followup, as required by this protocol.\n8. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential must agree to use effective contraception while on study and for at least 5 months after the last dose of study drug. Nonsterile male participants must agree to use a condom while on study and for up to 5 months after the last dose of study drug. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm), and intrauterine devices (IUDs).\n\nExclusion Criteria:\n\n1. Histologically documented primary CNS lymphoma, CLL, Burkitt, or Burkitt-like lymphoma.\n2. Known hypersensitivity to sulfa-containing study medication(s), including anaphylactic reaction to sulfa-containing medications.\n3. Known allergy to albumin (human) or dimethyl sulfoxide (DMSO).\n4. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment related complications.\n5. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as \\> 20 mg of prednisone or equivalent daily.\n6. History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.\n7. Anti-CD20 antibody treatment less than 2 weeks prior to cell infusion.\n8. History of receiving allograft organ transplant requiring immunosuppression.\n9. Participants post solid organ transplant who develop high grade lymphomas or leukemias.\n10. CD19- and CD20-positive metastases to the CNS, including the parenchyma\n11. Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).\n12. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).\n13. Inadequate organ function, evidenced by the following laboratory results:\n\n    1. ANC \\\u003C 1000 cells\u002Fmm3.\n    2. Platelet count \\\u003C 100,000 cells\u002Fmm3.\n    3. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome or indirect hyperbilirubinemia).\n    4. Aspartate aminotransferase (AST \\[SGOT\\]\u002FALT (SGPT) ≥ 2.5 × ULN.\n    5. Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases).\n    6. Serum creatinine \\> 1.6 mg\u002FdL.\n    7. Each study site should use its institutional ULN to determine eligibility.\n14. Uncontrolled hypertension (systolic \\> 160 mm Hg and\u002For diastolic \\> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident\u002Fstroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.\n15. Current chronic daily treatment (continuous for \\> 3 months) with systemic corticosteroids defined as \\> 20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed.\n16. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.\n17. Tested positive for tuberculosis (TB) utilizing the QuantiFERON Gold TB test.\n18. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \\\u003C 350 cells\u002FμL and a detectable HIV viral load.\n19. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.\n20. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n21. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n22. Women who are pregnant or breastfeeding","99 Years",{"count":251,"type":21},10,[211],"Open Label, Phase 1 study of CD19 t-haNK as a single agent and combination with rituximab in subjects with selected CD19+ and CD20+ R\u002FR B-cell non-Hodgkin Lymphoma( NHL).",[255],"Non-Hodgkin Lymphoma Refractory\u002F Relapsed",{"date":236,"type":36},{"date":258,"type":36},"2024-08-23",{"date":260,"type":21},"2028-03",{"name":42,"class":43},3,{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":52,"minAge":270,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":277,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":44},"100635751","phase-1-a-safety-and-efficacy-study-of-cd-19-t-hank-in-patients-with-b-cell-acute-lymphoblastic-leukemia-100635751","NCT07556757","A Safety and Efficacy Study of CD-19 t-haNK in Patients With B-cell Acute Lymphoblastic Leukemia","A Phase 1 Open-label Study of CD19 t-hANK as a Single Agent in Participants With Selected CD19+ Relapsed B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age ≥ 12 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee (HREC) or Independent Ethics Committee (IEC) guidelines.\n3. Histologically or flow cytometry documented pre B-ALL.\n4. Relapsed after achieving a 2nd complete remission (CR) or failed one cycle of re-induction therapy or with MRD positivity after ≥ 2 cycles of induction.\n5. Must be willing to undergo a lumbar puncture (LP) for CSF analysis and administration of IT chemotherapy.\n6. Performance status: Lansky score \\>60%, for participant ≥12 to \\\u003C16 years. Eastern Cooperative Oncology Group (ECOG) score of ≤ 1 for participants ≥ 16 years.\n7. Expected survival \\> 16 weeks.\n8. Stated willingness to comply with study procedures.\n9. Able to attend required study visits and return for adequate follow-up, as required by this protocol.\n10. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential must agree to use effective contraception while on study and for at least 30 days after the last dose of study drug. Nonsterile male participants must agree to use a condom while on study and for up to 5 months after the last dose of study drug. Effective contraception includes orals, injectables, surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm), and implants such as intrauterine devices (IUDs).\n\nAll inclusion criteria must be answered \"yes\" for a participant to participate in the trial.\n\nExclusion Criteria:\n\n1. Participants with T-cell leukaemia and Burkitt's M3 leukaemia.\n2. Known hypersensitivity or allergy to any component of the study medication(s), including sulfa-containing (eg, dimethyl sulfoxide, DMSO).\n3. Inadequate organ function, evidenced by the following laboratory results:\n\n   1. Serum creatinine ≥ 2 mg\u002FdL\n   2. Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) ≥ 5 upper limit of normal (ULN)\n   3. Total bilirubin ≥ 2 mg\u002FdL\n4. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment related complications.\n5. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as \\> 20 mg of prednisone or equivalent daily.\n6. History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.\n7. History of receiving allograft organ transplant requiring immunosuppression.\n8. Participants post solid organ transplant who develop high grade lymphomas or leukaemias.\n9. Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).\n10. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).\n11. Uncontrolled hypertension (systolic \\> 160 mm Hg and\u002For diastolic \\> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident\u002Fstroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association Class 2 or higher; or serious cardiac arrhythmia requiring medication.\n12. Current chronic daily treatment (continuous for \\> 3 months) with systemic corticosteroids defined as \\> 20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed.\n13. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.\n14. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \\\u003C 350 cells\u002FμL and a detectable HIV viral load.\n15. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.\n16. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n17. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n18. Women who are pregnant or breastfeeding.\n\nAll exclusion criteria must be answered \"no\" for a participant to participate in the trial.","12 Years",{"count":251,"type":21},[211],"This is a phase 1, open-label study to evaluate the safety and efficacy of CD19 t-haNK in patients with B-cell acute lymphoblastic leukemia. Up to 10 patients will receive at least 1 dose of study drug.",[275,276],"B-ALL","Leukemia",[278,279,280],"B-Cell","Acute","Lymphoblastic","2026-04-22",{"date":218,"type":36},{"date":284,"type":36},"2025-04-11",{"date":286,"type":21},"2028-12",{"name":42,"class":43},{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":44},"100486811","phase-1-study-for-subjects-with-relapsedrefractory-non--hodgkin-lymphoma-100486811","NCT05618925","Study for Subjects With Relapsed\u002FRefractory Non- Hodgkin Lymphoma","Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed\u002FRefractory Non-Hodgkin Lymphoma.","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.\n3. Histologically documented CD19- and CD20-positive B-cell NHL with the following specific criteria:\n\n   1. Have active disease after ≥ 2 lines of cytotoxic chemotherapy.\n   2. Have received rituximab or another anti-CD20 antibody.\n   3. Have either failed autologous transplant or are ineligible to receive autologous transplant.\n   4. Have measurable disease by Lugano classification documented within 8 weeks of the time of consent, defined as nodal lesions \\> 15 mm in the long axis or extranodal lesions \\> 10 mm in long and short axis, or bone marrow involvement that is biopsy proven.\n   5. Have CD19- and CD20-positive disease on most recent biopsy performed (a repeat biopsy is not mandatory for this study except as noted below). A minimum of 5% CD19 and CD20 positivity by immunohistochemistry or flow cytometry on prior or repeat biopsy is required.\n4. History of central nervous system (CNS) involvement with cerebral spinal fluid (CSF) analysis following magnetic resonance imaging (MRI) brain and lumbar puncture showing no evidence of CNS involvement by cytology and flow cytometry.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n6. Expected survival \\> 12 weeks.\n7. Willing and able to have central line placed for study drug infusions.\n8. Stated willingness to comply with study procedures.\n9. Able to attend required study visits and return for adequate follow-up, as required by this protocol.\n10. Agreement to practice effective contraception for female subjects of child-bearing potential and nonsterile males. Female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 5 months after the last dose of study drug. Nonsterile male subjects must agree to use a condom while on study and for up to 5 months after the last dose of study drug. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the study medication(s), including anaphylactic reaction to sulfur-containing medications.\n2. Known allergy to albumin (human) or dimethyl sulfoxide (DMSO).\n3. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.\n4. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as \\> 20 mg of prednisone or equivalent daily.\n5. History of allogeneic hematopoietic stem-cell transplantation (HSCT) or allogeneic chimeric antigen receptor (CAR) T therapy within 6 months of day 1 or require ongoing systemic graft versus host disease (GvHD) therapy.\n6. Anti-CD19 or anti-CD20 antibody treatment within 4 weeks of cell infusion.\n7. Live vaccine \\\u003C 6 weeks prior to starting lymphodepleting chemotherapy.\n8. History of receiving allograft organ transplant requiring immunosuppression.\n9. Subjects post solid organ transplant who develop high grade lymphomas or leukemias.\n10. Known lymphomatous involvement of the CNS, including the parenchyma or leptomeninges.\n11. Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).\n12. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).\n13. Inadequate organ function, evidenced by the following laboratory results:\n\n    1. ANC \\\u003C 1000 cells\u002Fmm3.\n    2. Platelet count \\\u003C 100,000 cells\u002Fmm3.\n    3. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome or indirect hyperbilirubinemia).\n    4. Aspartate aminotransferase (AST \\[SGOT\\])\u002FALT (SGPT) ≥ 2.5 × ULN.\n    5. Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in subjects with bone metastases).\n    6. Serum creatinine \\> 1.6 mg\u002FdL. Each study site should use its institutional ULN to determine eligibility.\n14. Uncontrolled hypertension (systolic \\> 160 mm Hg and\u002For diastolic \\> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident\u002Fstroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.\n15. Current chronic daily treatment (continuous for \\> 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg\u002Fday methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.\n16. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.\n17. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \\\u003C 500 cells\u002FμL..\n18. Chronic carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive. NOTE: Subjects who have a history of HIV\u002FHBV or who are seropositive will require testing for Infectious Disease Markers (IDM).\n19. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n20. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n21. Women who are pregnant or breastfeeding. A negative urine or serum pregnancy test in women of child bearing potential is required at screening and again within 48 hours prior to lymphodepleting chemotherapy",{"count":20,"type":21},[211],"Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed\u002FRefractory Non-Hodgkin Lymphoma. Up to 20 subjects will be enrolled and randomized 1:1 to 1 of 2 cohorts, as outlined below. The initial 3 subjects will be sequentially enrolled in a staggered fashion, with a 7 day interval between each subject to enable the capture and monitoring of any acute and subacute toxicities.",[299],"Non Hodgkin's Lymphoma Refractory\u002FRelapsed","2026-03-27",{"date":302,"type":36},"2026-04-01",{"date":304,"type":36},"2025-08-22",{"date":306,"type":21},"2027-03-15",{"name":42,"class":43},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":18,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},"100577643","phase-1-resq133a-nmibc-intravesical-recombinant-mycobacterium-rmbcg-in-participants-with-nmibc-eligible-to-receive-intravesical-tice-bcg-100577643","NCT06800963","ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG","ResQ133A-NMIBC: Phase 1\u002F2 Clinical Trial of Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG","Inclusion Criteria:\n\nParticipants must meet ALL of the following criteria for inclusion in the study:\n\n1. Male or female participants 18 years of age or older.\n2. Histologic confirmation of BCG naïve non-muscle invasive urothelial carcinoma of the bladder (mixed histology tumors allowed if urothelial histology is predominant histology) AND either i) histologically confirmed presence of NMIBC CIS (with or without Ta\u002FT1 papillary disease) OR ii) primary or recurrent stage Ta and\u002For T1 papillary tumors following transurethral resection (TUR).\n3. Absence of resectable disease after TURBT procedures (residual CIS acceptable; participants with T1 tumors must undergo repeat resection and biopsy \\[inclusive of muscularis propria\\] of the T1 tumor site if initial biopsy did not include muscularis propria).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n5. Voluntary written informed consent and agreement to comply with all protocol specified procedures and follow-up evaluations.\n\nExclusion Criteria:\n\nParticipants with ANY of the following criteria are excluded from participation in the study:\n\n1. Life expectancy \\\u003C2 years\n2. Any of the following clinical laboratory values at the time of enrollment:\n\n   1. Absolute neutrophil count (ANC) \\\u003C800\u002FμL\n   2. Platelets \\\u003C 50,000\u002FμL\n   3. Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\]) \\> 2 X upper limit of normal (ULN)\n   4. Renal insufficiency as indicated by a creatinine level \\>3 X ULN\n3. History of or evidence of muscle-invasive, locally advanced, metastatic and\u002For extravesical bladder cancer (inclusive of the prostatic urethra); or any other cancer within the past 5 years that is progressing or requires active treatment. Exceptions are adequately treated basal cell or squamous cell skin cancer that has undergone potentially curative therapy or in situ cervical cancer; and adequately treated stage I or II cancer or stable prostate cancer from which the participant is currently in complete remission, and is under active surveillance or hormone control.\n4. Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV heart failure or other clinical signs of severe cardiac dysfunction.\n5. Severe\u002Funstable angina pectoris, or myocardial infarction within 6 months prior to study entry.\n6. History or evidence of uncontrollable central nervous system disease.\n7. Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.\n8. Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions.\n9. Ongoing chronic systemic steroid therapy required (\\>10 mg oral prednisone daily or equivalent).\n10. Women who are pregnant or nursing. Female participants of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (eg, hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.\n11. Participants currently receiving investigational or commercial anticancer agents or anticancer therapies other than rMBCG and supportive care therapies for active disease.\n12. Concurrent use of other investigational agents (not including FDA authorized drugs for the prevention and treatment of COVID-19).\n13. Other illness or condition, including laboratory abnormalities, which in the opinion of the Investigator would exclude the participant from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study.",{"count":112,"type":21},[211,24],"This is a phase 1\u002F2, open-label, multicenter study of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) in participants with Non-muscle invasive bladder cancer (NMIBC) who have not received Bacillus Calmette-Guérin and have histologically confirmed presence of Carcinoma in situ (CIS) or have primary or recurrent stage Ta and\u002For T1 papillary tumors following Transurethral resection.",[96],"2026-03-26",{"date":300,"type":36},{"date":322,"type":36},"2025-10-15",{"date":324,"type":21},"2028-02",{"name":42,"class":43},9,{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":346,"locationsCount":4},"100629645","phase-2-study-of-cd19-t-hank-and-nai-with-rituximab-in-participants-with-indolent-non-hodgkin-lymphoma-100629645","NCT07477366","Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma","Open-Label, Phase 2 Chemotherapy-Free Study of CD19 t-haNK and NAI in Combination With Rituximab in Participants With Relapsed\u002FRefractory B-Cell Indolent Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Age ≥ 18 to ≤ 75 years old.\n2. Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.\n3. Histologically or flow cytometry documented relapsed\u002Frefractory B-cell indolent NHL (iNHL) including but not limited to follicular lymphoma \\[FL\\]; lymphoplasmacytic lymphoma \\[LPL\\], also known as Waldenstrom macroglobulinemia \\[WM\\]; marginal zone lymphoma \\[MZL\\] with the following specific criteria:\n\n   1. Have completed ≥ 2 lines of cytotoxic chemotherapy.\n   2. Have received rituximab or another anti-CD20 antibody.\n   3. Have measurable disease by Lugano classification documented within 8 weeks of the time of consent, defined as nodal lesions \\> 15 mm in the long axis or extranodal lesions \\> 10 mm in long and short axis, or bone marrow involvement that is biopsy proven.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n5. Stated willingness to comply with study procedures.\n6. Able to attend required study visits and return for adequate follow-up, as required by this protocol.\n7. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative pregnancy test and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive, or an intrauterine device \\[IUD\\]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 12 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 12 months post last dose of study drug).\n\nExclusion Criteria:\n\n1. Histologically documented large B-cell lymphomas (eg, diffuse large B-cell lymphoma \\[DLBCL\\], anaplastic large cell lymphoma \\[ALCL\\], follicular large cell lymphoma, mantle cell lymphoma), primary central nervous system (CNS) lymphoma, chronic lymphocytic leukemia (CLL), Burkitt and Burkitt-like lymphoma.\n2. Known hypersensitivity or allergy to any component of the study medications, including sulfa containing study medication(s) (eg, albumin \\[human\\], dimethyl sulfoxide \\[DMSO\\]).\n3. Inadequate organ function, evidenced by the following laboratory results:\n\n   1. ANC \\\u003C 1000 cells\u002Fmm3.\n   2. Platelet count \\\u003C 100,000 cells\u002Fmm3.\n   3. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome or indirect hyperbilirubinemia).\n   4. Aspartate aminotransferase (AST \u002FALT ≥ 2.5 × ULN.\n   5. Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases).\n   6. Serum creatinine ≥ 2 mg\u002FdL. NOTE: Each study site should use its institutional ULN to determine eligibility\n4. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment-related complications.\n5. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as \\> 20 mg of prednisone or equivalent daily.\n6. History of allogeneic hematopoietic stem cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.\n7. Anti-CD20 antibody treatment less than 2 weeks prior to cell infusion.\n8. History of receiving allograft organ transplant requiring immunosuppression.\n9. Participants that underwent a solid organ transplant who develop high grade lymphomas or leukemias.\n10. Metastases to the CNS, including the parenchyma or leptomeninges.\n11. Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).\n12. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).\n13. Uncontrolled hypertension (systolic \\> 160 mm Hg and\u002For diastolic \\> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident\u002Fstroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association Class 2 or higher; or serious cardiac arrhythmia requiring medication.\n14. Current chronic daily treatment (continuous for \\> 3 months) with systemic corticosteroids as defined as \\> 20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed.\n15. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.\n16. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \\\u003C 350 cells\u002FμL and\u002For a detectable HIV viral load.\n17. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.\n18. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n19. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n20. Women who are pregnant or breastfeeding.","75 Years",{"count":20,"type":21},[24],"Open-Label, Phase 2 Chemotherapy-Free Study ofCD19 t-haNK and NAI in Combination With Rituximab in Participants With Relapsed\u002FRefractory B-Cell Indolent Non-Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment.",[339],"Relapsed B-Cell Non-Hodgkin Lymphoma","2026-03-13",{"date":342,"type":36},"2026-03-17",{"date":344,"type":21},"2026-04",{"date":286,"type":21},{"name":42,"class":43},{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":4},"100579863","phase-2-clinical-trial-of-ablation-therapy-in-participants-with-intermediate-risk-non-muscle-invasive-papillary-bladder-cancer-100579863","NCT06829823","Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer","Phase 2 Clinical Trial of Ablation Therapy With Intravesical N-803 In Combination With BCG or Gemcitabine in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Low-grade (LG) Ta papillary disease as determined by Investigator.\n* History of LG NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT). Note: This refers to a previous episode(s) and not to the current episode for which the participant is being screened. Any presence of variant histology, or LVI should be deemed high-risk.\n* Negative voiding cytology for HG disease within 12 weeks prior to screening.\n* Intermediate-risk disease, defined as having 1 or 2 of the following:\n\n  1. Presence of \\>1 and \\\u003C 5 tumors;\n  2. Solitary tumor \\\u003C 3 cm;\n  3. Early or frequent recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis at the initial screening visit).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.\n* Voluntary written informed consent and HIPAA authorization and agreement to comply with all protocol-specified procedures and follow-up evaluations.\n\nExclusion Criteria:\n\n* Received BCG treatment for urothelial carcinoma.\n* History of HG bladder cancer (papillary or CIS) in the past 2 years.\n* Clinically significant urethral stricture that would preclude passage of a urethral catheter.\n* Life expectancy \\\u003C 2 years.\n* Any of the following clinical laboratory values at the time of enrollment:\n\n  1. Absolute lymphocyte count (ALC) \\> institutional lower limit of normal (LLN)\n  2. Absolute neutrophil count (ANC) \\\u003C 800\u002FμL\n  3. Platelets \\\u003C 50,000\u002FμL\n  4. Aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\]) \\> 2 × upper limit of normal (ULN).\n  5. Creatinine level \\> 3 × ULN. Note: Each study site should use its institutional LLN\u002FULN to determine eligibility.\n* History of or evidence of muscle-invasive, locally advanced, metastatic and\u002For extravesical bladder cancer (inclusive of the prostatic urethra); or any other cancer within the past 5 years that is progressing or requires active treatment. Exceptions are adequately treated basal cell or squamous cell skin cancer that has undergone potentially curative therapy or in situ cervical cancer; adequately treated stage I or II cancer or stable prostate cancer from which the participant is currently in complete remission, and is under active surveillance or hormone control; or any other cancer that investigator feels is stable with permission of Medical Monitor.\n* Suspicion of active upper tract urothelial malignancy.\n* Currently receiving investigational or commercial anticancer agents or anticancer therapies other than BCG, N-803, and supportive care therapies for active disease.\n* Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV heart failure, or other clinical signs of severe cardiac dysfunction.\n* Severe\u002Funstable angina pectoris, or myocardial infarction within 6 months prior to study entry.\n* History or evidence of uncontrollable central nervous system \\[CNS\\] disease.\n* Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.\n* Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions.\n* Ongoing chronic systemic steroid therapy required (\\>10 mg oral prednisone daily or equivalent).\n* Women who are pregnant or nursing. Female participants of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 7 months after the last dose of study drug, or be surgically sterilized (eg, hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.\n* Other illness or condition, including laboratory abnormalities, which in the opinion of the Investigator would exclude the participant from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study.",{"count":20,"type":21},[24],"This is an open-label, phase 2, randomized study of intravesical N-803 plus BCG (experimental arm A) and intravesical N-803 plus gemcitabine (experimental arm B) in participants who have intermediate-risk Ta\u002FT1 papillary disease. The primary objective of this study is to evaluate the efficacy of these experimental therapies without the need for surgical intervention by CR rate at month 3 or month 6 (for re-inducted participants).",[358],"Non-muscle Invasive Bladder Cancer (NMIBC)",[360,361,362,363,31],"ResQ132A-NMIBC","Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer","BCG","Gemcitabine","2025-10-14",{"date":366,"type":36},"2025-10-16",{"date":368,"type":21},"2025-11",{"date":370,"type":21},"2029-11",{"name":42,"class":43},{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":379,"conditions":380,"keywords":381,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":389,"locationsCount":126},"100589602","expanded-access-use-of-nogapendekin-alfa-inbakicept-in-the-reversal-and-maintenance-of-absolute-lymphocyte-count-alc-for-the-treatment-of-lymphopenia-induced-by-chemotherapy-immunotherapy-andor-radiation-therapy-100589602","NCT06956547","Expanded Access Use of Nogapendekin-alfa Inbakicept in the Reversal and Maintenance of Absolute Lymphocyte Count (ALC) for the Treatment of Lymphopenia Induced by Chemotherapy, Immunotherapy, and\u002For Radiation Therapy","ResQ117EX-ALC: Expanded Access Use of Nogapendekin-alfa Inbakicept in the Reversal and Maintenance of Absolute Lymphocyte Count (ALC) for the Treatment of Lymphopenia Induced by Chemotherapy, Immunotherapy, and\u002For Radiation Therapy","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Adult patients with solid tumors who progressed on standard-of-care treatment chemotherapy and\u002For immunotherapy and\u002For radiation therapy requiring second line or greater standard-of-care treatment with:\n\n   * Chemotherapy and\u002For\n   * Radiation therapy and\u002For\n   * Immune checkpoint inhibitor therapy and\u002For any therapy investigator deems appropriate at that institution\n3. Lymphocyte status meeting ONE of these conditions:\n\n   * Baseline absolute lymphocyte count (ALC) \\\u003C1,500 cells\u002FμL (mild lymphopenia) prior to treatment initiation in first line therapy or ALC \\\u003C1000 cells\u002FμL (severe lymphopenia) during and or following progression after first line therapy\n   * Anticipated treatment-induced lymphopenia (ALC reduction ≥20% from baseline based on reduction during first line therapy)\n   * Persistent lymphopenia (ALC \\\u003C1000 cells\u002FμL for \\>2 months during first line therapy treatment)\n\nExclusion Criteria:\n\n1. Active uncontrolled autoimmune disease requiring immunosuppression\n2. Participants with liquid tumors\n3. Concurrent solid organ transplantation","This is a protocol for expanded access use of nogapendekin-alfa inbakicept (NAI) in participants with lymphopenia induced by chemotherapy, immunotherapy, and\u002For radiation therapy who may benefit from its use, and who are ineligible to participate in a clinical trial using NAI. The primary objective of this protocol is to evaluate the reversal and maintenance of absolute lymphocyte count (ALC) with NAI.",[160],[382,383,384,385,386],"lymphopenia","lymphopenia induced by chemotherapy","lymphopenia induced by radiation therapy","lymphopenia induced by immunotherapy","absolute lymphocyte count","2025-10-10",{"date":364,"type":36},{"name":42,"class":43},""]