[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06549751":3,"trial-entities:NCT06549751":108,"trial-summary:NCT06549751":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":53,"secondary_outcomes":58,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":80,"locations":83,"central_contacts":93,"overall_officials":102,"references":106,"see_also_links":107},"NCT06549751","MRKR-22-601-02","MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer","A Phase 1 Study With Expansion of Patient-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-601) Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer (PANACEA)","NOT_YET_RECRUITING","2028-09-16","2026-04","2026-05-13","2026-07-16","Marker Therapeutics, Inc.","INDUSTRY",true,"The goal of this clinical trial is to assess safety and tolerability of escalating doses of MT-601 administered during the off week of chemotherapy regimen for patients with pancreatic cancer. The main question\\[s\\] it aims to answer are: safety and efficacy • overall response rate and duration of response. Participants will meet all applicable inclusion criteria prior to chemotherapy and must agree to provide apheresis material.","The Dose Escalation portion of the study will use a modified 3+3 design to define an acceptable dose of MT-601 in combination with maintenance capecitabine following completion of FFX or NLX chemotherapy. For the Dose Expansion, MT-601 will be administered at the dose determined to be safe based on the results from the Dose Escalation portion. Front-line chemotherapy (FOLFIRINOX or gemcitabine\u002Fnab-paclitaxel) will be administered as per standard of care. MT-601 will be administered intravenously over no less than 5 minutes as a single dose following completion of all planned doses of FFX or NLX chemotherapy and after participants have started receiving maintenance capecitabine.",[19,20,21],"Pancreas Cancer","Pancreatic Cancer Metastatic","Pancreatic Cancer (Unresectable)",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE1",{"count":28,"type":29},38,"ESTIMATED",[31,38,43,48],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","MT-601 dose 200 million cells","MT-601 Dose 200 million cells",[36,37],"Cohort -1 \u002F MT-601 dose 200 million cells","Dose Expansion",{"type":32,"name":39,"description":40,"armGroupLabels":41},"MT-601 dose 400 million cells","MT-601 Dose 400 million cells",[42,37],"Cohort 1 \u002F MT-601 dose 400 million cells",{"type":32,"name":44,"description":45,"armGroupLabels":46},"MT-601 dose 800 million cells","MT-601 Dose 800 million cells",[47,37],"Cohort 2 \u002F MT-601 800 million cells",{"type":32,"name":49,"description":50,"armGroupLabels":51},"MT-601 dose 1200 million cells","MT-601 Dose 1200 million cells",[52,37],"Cohort 3 \u002F MT-601 1200 million cells",[54],{"measure":55,"description":56,"timeFrame":57},"During Dose Escalation - determine the MTD, recommended expansion dose, or MPD of MT-601 administered during maintenance capacitabine following treatment with FOLFIRINOX (FFX) or NALIRIFOX (NLX).","Dose-limiting toxicities (DLTs)","Through study completion. Approximately 24 months",[59,63],{"measure":60,"description":61,"timeFrame":62},"During Dose Expansion - evaluate the safety profile of MT-601","To evaluate the safety profile of MT-601 administered during maintenance capecitabine following treatment with FFX or NLX\n\n-Safety (including but not limited to): TEAEs, SAEs, and deaths","Through study completion. Approximately 2.5 years",{"measure":64,"description":65,"timeFrame":62},"During Dose Escalation and Dose Expansion - determine the Efficacy of MT-601","Evaluate the efficacy of MT-601 administered during maintenance capecitabine following treatment with FFX or NLX with the endpoints of Progression Free Survival (PFS) and Duration of Response (DOR).","ALL","18 Years",null,false,{"inclusion":71,"exclusion":78,"raw_text":79},[72,73,74,75,76,77],"Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL (growth factor support allowed)","Platelets ≥75,000\u002Fmm3 (supportive medications allowed)","Hemoglobin ≥9 gm\u002FdL (transfusion allowed)","Total bilirubin ≤2.0 × ULN unless considered due to Gilbert's syndrome in which case, ≤ 3.0 x ULN","Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN OR ≤5 × ULN if known tumor involvement of liver","Serum creatinine ≤2 × ULN OR estimated glomerular filtration rate (using institutional standard) ≥50 mL\u002Fmin 11. Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of any study drugs",[],"Inclusion Criteria:\n\n1. Informed Consent\n2. Age ≥ 18 years\n3. ECOG performance status of 0 to 1\n4. Cytologically or histologically confirmed, locally advanced, unresectable or metastatic pancreatic adenocarcinoma (pancreatic carcinomas with at least some component of adenocarcinoma included).\n5. Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n6. Prior receipt of at least 4 doses (\\~2 months) of FFX or NLX with plans for completion of 12 doses (\\~6 months)\n7. Absence of progression during treatment with FFX or NLX (eg. CR, PR, or SD at study entry)\n8. Adequate pulmonary function with partial pressure of oxygen (pO2) on room air of at least 90%\n9. Adequate cardiac function with an ejection fraction ≥ 45%\n10. Adequate organ function, as defined below:\n\n    * Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL (growth factor support allowed)\n    * Platelets ≥75,000\u002Fmm3 (supportive medications allowed)\n    * Hemoglobin ≥9 gm\u002FdL (transfusion allowed)\n    * Total bilirubin ≤2.0 × ULN unless considered due to Gilbert's syndrome in which case, ≤ 3.0 x ULN\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN OR ≤5 × ULN if known tumor involvement of liver\n    * Serum creatinine ≤2 × ULN OR estimated glomerular filtration rate (using institutional standard) ≥50 mL\u002Fmin\n11. Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of any study drugs\n\nExclusion Criteria:\n\n1. Known CNS metastases or meningeal carcinomatosis unless treated and controlled for ≥ 3 months prior to the first administration of MT-601 without the need for increasing doses of steroids\n2. Other known active cancer likely to require additional treatment in the next 2 years unless approved by Medical Monitor\n3. Active bacterial, viral, or fungal infection requiring systemic therapy. Patients may be re-evaluated for eligibility upon completion of infection treatment.\n4. Significant cardiovascular risk (eg, coronary stenting within 4 weeks, myocardial infarction within 6 months)\n5. Diagnosis of significant immunodeficiency that in the Investigator or Medical Monitor's judgment would preclude participation in the study.\n6. Administration of systemic steroid therapy (\\> 10 mg\u002Fday of prednisone equivalent) ≤ 7 days prior to the first administration of MT-601\n7. Active autoimmune disease that required systemic treatment in the past 2 years (replacement therapies excluded \\[eg, thyroxine, insulin, physiologic corticosteroids\\])\n8. History of solid organ or hematologic transplant\n9. Known HIV\n10. Evidence of active hepatitis B as defined by:\n\n    1. Positive hepatitis B surface antigen (HBsAg), or\n    2. Negative HBsAg but a positive hepatitis B surface antibody (HBsAb) or positive hepatitis B core antibody (HBcAb) with a positive hepatitis B virus (HBV) DNA\n11. Evidence of active hepatitis C as defined by:\n\n    a. Positive anti-hepatitis C virus antibody (HCVAb) with a positive hepatitis C virus (HCV) RNA by PCR\n12. Pregnant or currently breast-feeding\n13. Psychiatric illness\u002Fsocial situations that would interfere with compliance with study requirements",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"The University of Texas MD Anderson","Houston","Texas","77030","United States",{"lat":91,"lon":92},29.76328,-95.36327,[94,99],{"name":95,"role":96,"phone":97,"email":98},"Patricia Allison, BS","CONTACT","7174715205","pallison@markertherapeutics.com",{"name":100,"role":96,"phone":101},"Kaylor Hopkins","(817) 395-2275",[103],{"name":95,"affiliation":104,"role":105},"Marker Therapeutics","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":109,"biomarkers":111},[110],"Pancreatic Carcinoma",[],{"nct_id":4,"found":15,"summary":113,"prompt_version":123},{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This study will enroll 38 participants and uses a modified 3+3 design to find the right dose of MT-601. It will then expand to further test the chosen dose.","completed","MT-601 for Locally Advanced or Metastatic Pancreatic Cancer","This study is testing a new treatment called MT-601 for people with pancreatic cancer that has spread or cannot be removed by surgery. Researchers want to find out the safest and most effective dose of MT-601 when given during a break from chemotherapy (like FOLFIRINOX or NALIRIFOX) and while you are receiving maintenance capecitabine. The study will look at how safe MT-601 is, how well it works to shrink tumors, and how long those effects last. You may be able to join if you are at least 18 years old, have a good performance status (meaning you can perform daily activities), and have pancreatic adenocarcinoma that is measurable.","The study will follow participants through study completion, which is approximately 24 months.",108,"MT-601 will be given as a single intravenous (into a vein) dose after you finish your initial chemotherapy and have started maintenance capecitabine. You will also need to provide apheresis material (a blood donation where certain cells are collected).","Not stated in the trial record.",[],"v2"]