[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphopenia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphopenia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,80,102,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100530044","serologic-response-to-pneumococcal-vaccination-among-esophageal-cancer-patients-with-high-grade-lymphopenia-after-chemoradiation-100530044",false,"NCT06181656","Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation","Inclusion Criteria:\n\n1. Group 1A\n\n   a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons.\n2. Group 1B\n\n   a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)\n3. Group 2A\n\n   a. Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable liver cancer.\n4. Group 2B\n\n   a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable liver cancer.\n5. Group 3\n\n   a. Healthy age- and gender- matched individuals\n6. All Groups\n\n   1. Patients of all genders, races and nationalities will be solicited.\n   2. Age \\>18 years\n   3. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients with compromised immunologic responses due to an uncontrolled intercurrent immunodeficiency (e.g., Human immunodeficiency virus (HIV), X-linked agammaglobulinemia) or previous or current immune suppressive therapy\n\n  a. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Patients receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Individuals with previous pneumococcal vaccination in the last 5 years.\n* Individuals with severe allergy to any of the vaccine components",true,"ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","OBSERVATIONAL","To learn how radiation treatment may affect your responses to vaccines against pneumonia.",[24,25,26,27],"Pneumococcal Vaccine","Esophageal Cancer","Lymphopenia","Chemoradiation","RECRUITING","2026-05-19",{"date":31,"type":32},"2026-05-20","ACTUAL",{"date":34,"type":32},"2024-02-05",{"date":36,"type":20},"2027-07-04",{"name":38,"class":39},"M.D. Anderson Cancer Center","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"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":49,"type":20},50,"INTERVENTIONAL",[52],"PHASE2","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.",[55,56,26,57,58],"Sepsis","Septic Shock","Immunosuppression","Critical Illness",[55,60,61,57,62,63,64,65,66,67,68],"Septic shock","Persistent lymphopenia","IL-15 receptor agonist","Nogapendekin alfa inbakicept","N-803","ANKTIVA","Immune reconstitution","Critical care","ICU","NOT_YET_RECRUITING","2026-05-05",{"date":72,"type":32},"2026-05-11",{"date":74,"type":20},"2026-07-06",{"date":76,"type":20},"2027-10-04",{"name":78,"class":79},"ImmunityBio, Inc.","INDUSTRY",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":50,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":40},"100612790","phase-2-evaluation-of-the-effect-of-cordycepin-on-cd8-lymphocytopenia-in-patients-with-solid-tumors-100612790","NCT07258160","Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors","Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors: A Randomized Withdrawal Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Participants with solid malignant tumors, with confirmed pathological diagnosis or medical history; they have completed radiotherapy and\u002For chemotherapy more than six months ago; and peripheral blood CD8+ absolute count (blood drawn before 10:00 AM) below the lower reference limit (LRL);\n3. No treatment with immunomodulatory or immunosuppressive agents within the past 2 weeks prior to enrollment;\n4. ECOG performance status score of 0-1, with an estimated life expectancy of ≥ 3 months;\n5. AST and ALT ≤ 3.0 times the upper limit of normal (ULN) within one week prior to study enrollment; serum creatinine ≤ 2 times ULN;\n6. Ability to understand the study and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n1. History of uncontrolled epilepsy, central nervous system (CNS) disease, or mental disorders, as determined by the investigator to be clinically significant and potentially interfere with the participant's ability to provide informed consent or comply with medication;\n2. Significant (i.e., active) cardiovascular disease, including symptomatic coronary heart disease, congestive heart failure classified as New York Heart Association (NYHA) Class II or worse, or serious arrhythmias requiring pharmacological intervention, or history of myocardial infarction within the past 12 months;\n3. Known active serious infections, or in the investigator's opinion, presence of major hematological, renal, metabolic, gastrointestinal, or endocrine dysfunction, or other serious, uncontrolled comorbidities;\n4. History of allergy to fungi, or to any of the following components: Cordyceps militaris extract powder, D-mannitol, maltitol, microcrystalline cellulose, or magnesium stearate;\n5. History of immunodeficiency, including HIV positive status, or diagnosis with other acquired or congenital immunodeficiencies, or a history of organ transplantation, or immunological disorders requiring long-term oral corticosteroid treatment;\n6. Acute gout flare\n7. Any other condition deemed unsuitable for enrollment by the investigator.",{"count":88,"type":20},127,[52],"The goal of this clinical trial is to evaluate the effectiveness of PRaG-1 in improving CD8+ lymphocytopenia in patients with solid tumors who are tumor-free for more than six months after completing radiotherapy and\u002For chemotherapy. It will also assess the safety of PRaG-1 Cordycepin in these patients. The main questions it aims to answer are:\n\nDoes PRaG-1 increase CD8+ lymphocyte counts by more than 25% in this patient population? Does the effect of PRaG-1 maintain when treatment is discontinued? What are the safety and tolerability profiles of PRaG-1 during and after the treatment period? Participants will receive open-label PRaG-1 (one tablet in the morning and one in the evening) for 14 days, and those who show a response (CD8+ lymphocytes increase by more than 25%) will enter a 14-day randomized withdrawal period, where they will be assigned to continue PRaG-1 or switch to a placebo.\n\nThroughout the study, participants will:\n\nHave their peripheral blood lymphocyte subpopulations tested at baseline and on Days 7 and 14 Undergo safety monitoring for adverse events according to CTCAE 5.0 criteria Provide information on their quality of life during the treatment period Researchers will compare the outcomes of those who continue PRaG-1 to those who receive a placebo to determine if the observed improvement in CD8+ lymphocytes is sustained, which would indicate that the drug is effective in maintaining immune response.",[92,26],"Solid Cancer","2026-01-07",{"date":95,"type":32},"2026-01-09",{"date":97,"type":32},"2025-12-01",{"date":99,"type":20},"2026-09",{"name":101,"class":39},"Second Affiliated Hospital of Soochow University",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":50,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100613487","phase-2-prag-1-plus-prag-therapy-in-advanced-solid-tumors-a-prospective-clinical-trial-prag-100-100613487","NCT07267234","PRaG-1 Plus PRaG Therapy in Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0)","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Histologically confirmed treatment-naïve or relapsed\u002Fmetastatic advanced solid malignancies with no standard treatment option per current clinical guidelines or intolerance to standard therapy; measurable metastatic lesions ≥1 cm (by RECIST criteria); absolute lymphocyte count (ALC) below lower limit of normal (LLN).\n3. No history of congestive heart failure, unstable angina, or unstable cardiac arrhythmias within the past 6 months.\n4. ECOG performance status 0-3; estimated life expectancy ≥3 months.\n5. No history of significant hematologic, cardiac, pulmonary, hepatic, or renal dysfunction.\n6. Baseline AST ≤3×ULN and ALT ≤3×ULN (≤5×ULN for hepatocellular carcinoma or liver metastases); creatinine ≤3×ULN.\n7. Capacity to comprehend study procedures and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n1. History of other malignancies within the past 5 years, except for adequately treated non-melanoma skin cancer or cervical carcinoma in situ.\n2. Uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders that, in the investigator's judgment, may interfere with informed consent or treatment adherence.\n3. Clinically significant active cardiac disease, including symptomatic coronary artery disease, NYHA Class II or higher congestive heart failure, severe arrhythmias requiring pharmacological intervention, or myocardial infarction within the past 12 months.\n4. History of solid organ transplant requiring ongoing immunosuppressive therapy.\n5. Known significant active infection, or significant hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction, or other serious uncontrolled comorbidities as determined by the investigator.\n6. Allergy to any component of the study drug(s).\n7. History of immunodeficiency, including HIV infection, acquired or congenital immunodeficiency disorders, solid organ transplant, or chronic immunosuppressive therapy for immune-related conditions.\n8. Active or latent tuberculosis infection confirmed by positive T-SPOT.TB test or chest X-ray findings suggestive of tuberculosis.\n9. Any other condition that, in the investigator's clinical judgment, may compromise study participation or safety.",{"count":109,"type":20},65,[52],"The goal of this clinical trial is to learn if a combination treatment using PRaG-1 Cordycepin Tablets with radiation therapy, immune-boosting injections, and immunotherapy drugs can help patients with advanced solid tumors. It will also assess safety. The main questions it aims to answer are:\n\nDoes this treatment improve immune function and slow tumor growth? What side effects or risks occur during treatment?\n\nParticipants will:\n\nTake PRaG-1 Cordycepin Tablets (a natural compound derived from Cordyceps fungus) orally: higher dose for 7 days before radiation, then lower daily dose for 2 weeks Receive targeted radiation therapy to the tumor area (5-12 Gy total in 2-3 sessions) Get daily immune-boosting injections (GM-CSF) for 7 days starting with radiation Receive immunotherapy drugs (PD-1\u002FPD-L1 inhibitors) within one week after radiation Have blood drawn and small tumor tissue samples taken before and after the first two treatment cycles for immune analysis All participants will receive this combination treatment; there is no placebo or alternative treatment group in this study.",[92,26,113,114],"Radiotherapy","Immune Checkpoint Inhibitor","2025-11-24",{"date":117,"type":32},"2025-12-05",{"date":97,"type":20},{"date":120,"type":20},"2027-09-01",{"name":101,"class":39},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":142,"locationsCount":40},"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","EXPANDED_ACCESS","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.",[26],[133,134,135,136,137],"lymphopenia","lymphopenia induced by chemotherapy","lymphopenia induced by radiation therapy","lymphopenia induced by immunotherapy","absolute lymphocyte count","AVAILABLE","2025-10-10",{"date":141,"type":32},"2025-10-14",{"name":78,"class":79}]