Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT06549751
Eligibility Criteria:
Inclusion Criteria:
1. Cytologically or histologically confirmed newly diagnosed locally advanced, unresectable or metastatic pancreatic adenocarcinoma (excluding other pancreatic malignancies such as acinar cell carcinomas or neuroendocrine cell neoplasms, etc.).
2. Eligible for reassessment following 2 months of front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel): Patient must have experienced a response of SD, PR, or CR per RECIST v1.1 after 2 months of front-line chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel).
3. ≥18 years of age prior to administration of MT-601.
4. Measurable or evaluable disease per RECIST v1.1 at the time of screening.
5. Must have sufficient leukapheresis material to manufacture autologous MT601.
6. Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
7. Life expectancy ≥12 weeks.
8. Pulse oximetry of \>90% on room air in patients with previous radiation therapy.
9. Adequate organ function, as defined below:
* Absolute neutrophil count (ANC) ≥1.5 × 109/L
* Platelets ≥75 × 109/L
* Hemoglobin ≥9 g/dL (can be transfused)
* International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × upper limit of normal (ULN) (unless patient receiving stable dose of anticoagulant therapy as long as PT or INR in therapeutic range of intended anticoagulant)
* Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) PTT or aPTT ≤ 5 seconds above ULN (unless patient receiving stable dose of anticoagulant therapy "a" as long as PT or INR in therapeutic range of intended anticoagulant)
* Total bilirubin ≤2 × ULN
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN OR ≤5 × ULN if liver has tumor involvement
* Serum creatinine OR calculated (as per institutional standards) creatinine clearance ≤2 × ULN OR measured or calculated ≥50 mL/min for patients "a" If receiving anticoagulation, the patient must have no active bleeding within 14 days prior to baseline assessment.
10. Sexually active patients must be willing to utilize one of the highly effective birth control methods or practice complete abstinence between initiation of screening for MT-601 infusion and 6 months after the last MT-601 infusion. Male patients who are sexually active must agree to use a condom during this period.
11. Disease imaging prior to administration of front-line chemotherapy and reimaging prior to administration of MT-601.
Exclusion Criteria:
* N/A
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06549751
Study Brief:
Protocol Section:
NCT06549751