[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cullinan Therapeutics Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":117},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,69,95],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100563222","phase-1-a-study-of-cln-978-a-subcutaneously-administered-cd19-directed-t-cell-engager-in-subjects-with-systemic-lupus-erythematosus-100563222",false,"NCT06613360","A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus","A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n* Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR \u002F ACR Classification Criteria at screening.\n* Presence of one or more of the following autoantibodies documented during screening or in the previous 12 months before screening: positive anti-nuclear antibody (ANA) test (≥1:80); anti dsDNA above the upper limit of normal (ULN); anti-Sm above the ULN.\n* Active SLE disease, as demonstrated by a SLEDAI total score ≥6 at screening.\n* Inadequate response to at least 2 of the following treatments: oral corticosteroid, antimalarials, conventional immunosuppressants, or biologics. At least one of the failed treatments should be an immunosuppressive or biologic standard-of care agent.\n* If on corticosteroid and\u002For antimalarial, the dose must be stable prior to day 1.\n* Laboratory parameters including the following:\n\n  * Absolute lymphocyte count (ALC) ≥0.5 x 109\u002FL\n  * Peripheral B cell count ≥25 cells\u002FµL\n  * Absolute neutrophil count (ANC) ≥1.0 x 109\u002FL\n  * Hemoglobin ≥8 g\u002FdL\n  * Platelet count ≥75 x 109\u002FL.\n  * Estimated glomerular filtration rate (eGFR) (based on CKD-EPI formula) ≥30 mL\u002Fmin\u002F1.73m2\n  * Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN\n* Part B only: For patients who were treated in Part A and did not experience dose-limiting toxicity (DLT) or discontinue CLN-978 treatment due to AEs are eligible for retreatment at a higher dose or longer schedule in Part B if they otherwise meet eligibility criteria and at least 90 days have passed since the last dose of CLN-978.\n\nExclusion Criteria:\n\n* Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed.\n* Considered at high risk for thrombosis.\n* Rapidly progressive glomerulonephritis, and\u002For urine protein\u002Fcreatinine \\>3 mg\u002Fmg (339 mg\u002Fmmol).\n* Active severe neuropsychiatric\u002FCNS manifestations of SLE.\n* Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.\n* History of splenectomy.\n* Prior treatment with the following:\n\n  * Cellular or gene therapy product directed at any target.\n  * Investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1.\n  * Any anti-CD19 or anti-CD20 therapy less than 3 months prior to Day 1.\n  * Non-biologic DMARD within 14 days prior to Day 1.\n  * Cyclophosphamide within 1 month or a biologic immunomodulating therapy during 2 months prior to Day 1.\n* Live or attenuated vaccine within 28 days prior to screening or during screening.\n* Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including SARS-CoV-2 infection, within 14 days before Day 1.\n* Active or latent tuberculosis (TB) evidenced by a positive or indeterminant Interferon Gamma Release Assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB.\n* Any condition for which, in the opinion of the Investigator and\u002For Sponsor, would not be in the best interest of the patient to participate in the study or that could prevent, limit, or confound any protocol-defined assessment.","ALL","18 Years","70 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).",[27,28],"SLE","SLE (Systemic Lupus)",[30],"Systemic Lupus Erythematosus","RECRUITING","2026-06-04",{"date":34,"type":35},"2026-06-05","ACTUAL",{"date":37,"type":35},"2025-01-21",{"date":39,"type":21},"2027-12",{"name":41,"class":42},"Cullinan Therapeutics Inc.","INDUSTRY",20,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100592493","phase-1-a-study-of-cln-978-a-subcutaneously-administered-cd19-directed-t-cell-engager-in-subjects-with-rheumatoid-arthritis-100592493","NCT06994143","A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis","A Phase I, Open-Label Study of CLN-978 in Patients With Treatment-Refractory Rheumatoid Arthritis (RA)","Inclusion Criteria:\n\n* Documented diagnosis of RA which fulfills the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) Classification Criteria ≥12 weeks prior to screening.\n* Evidence of B-cell-driven disease at Screening or previous medical documentation, defined as either (i) seropositivity for RF and\u002For any AMPA and\u002For (ii) a synovial biopsy showing B-cell infiltration\n* Active RA disease, as demonstrated by a DAS28 - ESR ≥3.2 and at least one swollen joint at screening.\n* Inadequate response to at least 2 targeted treatments with different mechanisms. These can include tsDMARD and\u002For bDMARD, after failing conventional synthetic DMARD (unless contraindicated).\n* Local laboratory assessments must meet the following criteria:\n\n  * Absolute lymphocyte count (ALC) ≥0.5 x 10\\^9\u002FL\n  * Peripheral CD19+ B cell count ≥25 cells\u002FμL\n  * Absolute neutrophil count (ANC) ≥1.0 x 10\\^9\u002FL\n  * Hemoglobin (Hgb) ≥8 g\u002FdL\n  * Platelet count ≥75 x 10\\^9\u002FL\n  * Estimated glomerular filtration rate (eGFR) (based on the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula) ≥30 mL\u002Fmin\u002F1.73m\\^2\n  * Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN\n* Concurrent corticosteroids is permitted if the dose is ≤10 mg\u002Fday prednisone equivalent in the 2 weeks prior to initiation of study treatment. Hydroxychloroquine ≤400 mg\u002Fd or chloroquine ≤ 250 mg\u002Fd is allowed.\n\nExclusion Criteria:\n\n* Active inflammatory disease other than RA within 12 months prior to screening or during screening that may interfere with the study assessments. Thyroiditis or secondary Sjogren's syndrome is allowed.\n* Clinical evidence of any other significant unstable or uncontrolled acute or chronic disease not due to RA which, in the opinion of the Investigator could put the patient at undue risk or confound study results.\n* Prior treatment with the following:\n\n  * Cellular therapy (e.g., chimeric antigen receptor T-cell (CAR-T) or gene therapy product directed at any target.\n  * Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1 and during the study.\n  * Received any anti-CD19 or anti-CD20 therapy such as blinatumomab, obinutuzumab, rituximab, ocrelizumab, or ofatumumab within 3 months prior to Day 1.\n  * Non-biologic DMARD within 14 days prior to Day 1.\n  * Cyclophosphamide or a biologic immunomodulating therapy within 2 months of Day 1.\n* Live or live-attenuated vaccines within the 4 weeks prior to the Screening visit or during the Screening Period\n* Active or latent tuberculosis (TB) evidenced by a positive or indeterminant Interferon Gamma Release Assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB.",{"count":52,"type":21},37,[24],"A Phase I, open-label study of CLN-978 in patients with treatment-refractory rheumatoid arthritis.",[56],"Rheumatoid Arthritis (RA",[58,59],"RA","Treatment-refractory RA","2026-05-13",{"date":62,"type":35},"2026-05-15",{"date":64,"type":35},"2025-05-19",{"date":66,"type":21},"2028-12-30",{"name":41,"class":42},3,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100596103","phase-1-a-study-of-cln-978-a-subcutaneously-administered-cd19-directed-t-cell-engager-in-subjects-with-sjogrens-disease-100596103","NCT07041099","A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease","A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease","Inclusion\n\n* Diagnosis of SjD at least 24 weeks prior to Screening Visit and meet the 2016 EULAR \u002F ACR Classification Criteria for SjD at Screening.\n* Have active moderate to severe disease (i.e., ESSDAI ≥5) at Screening.\n* Laboratory parameters including the following:\n\n  * Absolute lymphocyte count (ALC) ≥0.5 × 10\\^9\u002FL\n  * Peripheral CD19+ B cell count ≥25 cells\u002FµL\n  * Absolute neutrophil count (ANC) ≥1.0 × 10\\^9\u002FL\n  * Hemoglobin (Hgb) ≥8 g\u002FdL\n  * Platelet count ≥75 × 10\\^9\u002FL\n  * Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome\n  * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 × ULN\n  * Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥30 mL\u002Fmin\u002F1.73 m2\n\nExclusion\n\n* Concomitant rheumatological autoimmune disease\n* Considered at high risk for thrombosis\n* Rapidly progressive glomerulonephritis and\u002For urine protein\u002Fcreatinine \\>3 mg\u002Fmg (339 mg\u002Fmmol).\n* Active, severe central nervous system manifestations of SjD.\n* History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder that the Investigator feels would put the patient at undue risk or confound study results.\n* Evidence of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.\n* Primary immunodeficiency or history of recurrent infections.\n* History of splenectomy.\n* Live or attenuated vaccine within 28 days prior to the Screening Visit or during the Screening Period.\n* Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, within 14 days prior to Day 1.\n* Active or latent tuberculosis (TB)",{"count":77,"type":21},36,[24],"A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.",[81,82,83],"Sjögren","Sjogren Disease","Sjogren's Syndrome",[85],"CLN-978","2026-03-20",{"date":88,"type":35},"2026-03-23",{"date":90,"type":35},"2025-10-01",{"date":92,"type":21},"2029-03-15",{"name":41,"class":42},11,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":94},"100450323","phase-1-cln-049-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-aml-or-myelodysplastic-syndrome-mds-100450323","NCT05143996","CLN-049 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)","A Phase 1, Open-label, Preliminary Pharmacokinetics (PK) and Safety Study of CLN-049 (An Fms-like Tyrosine Kinase 3 [FLT3] x Cluster of Differentiation 3 [CD3] Bispecific T Cell Engager) in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n1. Aged ≥ 18 years of age.\n2. Willing and able to give written informed consent and adhere to protocol requirements; written informed consent and any locally required authorization must be obtained from the patient prior to performing any protocol-related procedures, including screening evaluations, and serial samples of bone marrow and peripheral blood.\n3. Patient has a confirmed diagnosis of recurrent or refractory AML or MDS.\n4. Patient has received, and has progressed, recurred, or is intolerant of approved therapeutic options that are available, or declines treatment with these therapies.\n5. White blood cell (WBC) count at the time of the first dose is \\\u003C 20,000\u002FuL (hydroxyurea is permitted according to standard institutional practice). Following first dose, WBC should be checked prior to subsequent CLN-049 administration and if WBC \\> 20,000\u002FμL, CLN-049 treatment should be postponed (see Section 6.1 for further guidance).\n6. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 2.\n7. Toxicities related to prior study therapy should have resolved to Grade 1 or less according to criteria of NCI CTCAE v5.0, except for alopecia, lymphopenia, neutropenia, leukopenia, anemia, thrombocytopenia. Patients with chronic but stable toxicities may be allowed to enroll after agreement between the Investigator and Sponsor.\n8. The patient's laboratory values meet the following criteria:\n\n   1. Creatinine clearance (CrCl) as calculated by the Cockcroft-Gault formula (Appendix 1) must be ≥ 60 mL\u002Fmin;\n   2. Total bilirubin ≤ 1.5 × ULN. This does not apply for patients with confirmed Gilbert's Syndrome, hemolysis, or chronic blood transfusions, for whom total bilirubin must be less than 3.0 mg\u002FdL with a conjugated bilirubin less than 0.5 mg\u002FdL;\n   3. AST and ALT ≤ 3.0 × ULN (unless attributed to leukemic involvement).\n\nExclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia (APL)\n2. Active central nervous system (CNS) leukemia. For patients with a history of CNS leukemia, a lumbar puncture should be performed during screening to exclude the presence of active CNS involvement.\n3. Isolated extramedullary relapse\n4. Prior organ allograft\n5. Allogeneic hematopoietic transplantation within six months of treatment, or with clinical or laboratory evidence of GVHD, or requiring ongoing treatment with immune suppression within 2 months of the first dose of CLN-049.\n6. Treatment with any of the following:\n\n   1. Radiation therapy (XRT) within 28 days of the first dose of CLN049, or craniospinal XRT within 8 weeks of the first dose of CLN-049, or history of total body irradiation (TBI).\n   2. Prior immunotherapy with checkpoint inhibitors ≤ 42 days prior to the first dose of CLN-049.\n   3. Prior history of chimeric antigen receptor (CAR-T) cell therapy or other modified T cell therapy.\n   4. Anti-leukemic therapy except hydroxyurea for cytoreduction, and intrathecal chemotherapy ≤ 14 days or 5 half-lives, whichever is shorter, prior to the first dose of CLN-049.\n   5. Short-acting hematopoietic growth factors ≤ 7 days prior to the first dose of CLN-049\n   6. Long-acting growth factors ≤ 14 days prior to the first dose of CLN-049.\n   7. Systemic glucocorticoid therapy (except equivalent of \\\u003C 10 mg prednisone daily) or other immune-suppressive drugs ≤ 14 days prior to the first dose of CLN-049 (see separate guidelines for patients who are post allogeneic hematopoietic transplantation). The transient use of corticosteroids for transfusion premedication or the treatment of infusion or transfusion reactions will not be considered for this criterion. Topical corticosteroids and steroid eye drops are allowed, and will not exclude the patient from eligibility.\n   8. Prior treatment with a FLT3-directed bispecific molecule, or a FLT3-targeted antibody.\n7. Currently participating\u002Fpreviously participated in an interventional study and received an investigational drug within 14 days (or five half-lives, whichever is longer) prior to the first dose of CLN-049.\n8. Patients with concomitant second malignancies requiring active treatment in the past 12 months, or if additional therapy is required or anticipated during study participation.\n9. Patients with any active autoimmune disease or a history of known or suspected autoimmune disease, or history of a syndrome that requires systemic corticosteroids or immunosuppressive medications, except for patients with vitiligo, psoriasis (in consultation with the Sponsor), resolved childhood asthma\u002Fatopy or autoimmune thyroid disorders on stable thyroid hormone supplementation.\n10. A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy or whose control may be jeopardized by the complications of this therapy.\n11. Any concurrent condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug.\n12. Active uncontrolled infection within seven days of first dose of CLN-049. Prophylactic use of systemic antiviral, antibacterial, or antifungal agents for treatment of chronic, controlled infection or as prophylaxis is permitted.\n13. Has a history of, or a positive test for Human Immunodeficiency Virus (HIV) 1\u002F2 or primary immunodeficiency disease such as HIV.\n14. Known history of hepatitis B (with positive testing for either hepatitis B surface antigen \\[HBsAg\\] or hepatitis B core Ab), hepatitis C (HCV) infection (with positive testing for HCV antibody and\u002For HCV ribonucleic acid \\[RNA\\] in serum), or acute hepatitis A (with positive testing for hepatitis A IgM). Note: patients with chronic HCV with undetectable viral load defined by sustained virologic response 24 weeks (SVR24) after completion of anti-hepatitis C treatment will be eligible. Patients with hepatitis B surface antigen \\[HBsAg\\] or hepatitis B core Ab with negative viral load will be eligible.\n15. Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection including history of positive SARS-CoV-2 testing without subsequent documentation of negative test results, patients with results that are pending but not yet known, or patients with suspected active infection based on clinical features\n16. History of the following events in conjunction with prior treatment with immunotherapy: Grade 3 or greater neurotoxicity, ocular toxicity, pneumonitis, myocarditis, or colitis; liver dysfunction meeting the laboratory criteria for Hy's Law.\n17. Live virus vaccines within 28 days of the first dose of CLN-049, during treatment, and until the end of last dose of CLN-049.\n18. Woman of child-bearing potential (WOCBP) who is pregnant or breast-feeding, plans to become pregnant within 120 days of last study drug administration, or declines to use an acceptable method to prevent pregnancy during study treatment and for 120 days after the last dose of study drug administration.\n19. Male patient who plans to father a child or donate sperm within 120 days of last study drug administration, or who has a partner who is a WOCBP, and declines to use acceptable method to prevent pregnancy during study treatment and for 120 days after the last dose of study drug administration.\n20. QT interval corrected for heart rate using Fridericia's formula (QTcF) of ≥ 480 milliseconds.\n21. Patient has history of drug-related anaphylactic reactions to any components of CLN-049. History of Grade 4 anaphylactic reaction to any bispecific molecule or monoclonal antibody therapy.\n22. Known history of prior human anti-human antibody response. Patients will not be screened for human anti-human antibody prior to study participation.\n23. Known active alcohol or drug abuse.\n24. Patients who are incapacitated or involuntarily incarcerated.",{"count":103,"type":21},60,[24],"CLN-049-001 is a Phase 1, open-label, multicenter, first-in-human trial of CLN-049 in patients with Relapsed\u002FRefractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)",[107,108],"Relapsed\u002FRefractory Acute Myeloid Leukemia (AML)","Myelodysplastic Syndrome (MDS)","2026-01-14",{"date":111,"type":35},"2026-01-16",{"date":113,"type":35},"2021-11-18",{"date":115,"type":21},"2027-06",{"name":41,"class":42},""]