Immune cells Tailor-Made to attack pancreatic cancer enter first human test
NCT ID NCT06549751
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new therapy called MT-601, which uses a patient's own immune T-cells trained to recognize multiple cancer-related targets. It is for people with advanced pancreatic cancer that cannot be removed by surgery or has spread. The study will check safety and whether the cells can shrink tumors, with up to 38 participants receiving different doses alongside chemotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Patient-derived multi-tumor-associated antigen specific T cells (MT-601)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced pancreatic cancer that uses a patient's own immune cells to fight the tumor.
- What could go wrong
- This is a very early Phase 1 trial with only 38 participants, so safety and effectiveness are not yet proven. The therapy may not shrink tumors or could cause serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Informed Consent 2. Age ≥ 18 years 3. ECOG performance status of 0 to 1 4. Cytologically or histologically confirmed, locally advanced, unresectable or metastatic pancreatic adenocarcinoma (pancreatic carcinomas with at least some component of adenocarcinoma included). 5. Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 6. Prior receipt of at least 4 doses (\~2 months) of FFX or NLX with plans for completion of 12 doses (\~6 months) 7. Absence of progression during treatment with FFX or NLX (eg. CR, PR, or SD at study entry) 8. Adequate pulmonary function with partial pressure of oxygen (pO2) on room air of at least 90% 9. Adequate cardiac function with an ejection fraction ≥ 45% 10. Adequate organ function, as defined below: * Absolute neutrophil count (ANC) ≥1.0 × 109/L (growth factor support allowed) * Platelets ≥75,000/mm3 (supportive medications allowed) * Hemoglobin ≥9 gm/dL (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/min 11. Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of any study drugs Exclusion Criteria: 1. 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 2. Other known active cancer likely to require additional treatment in the next 2 years unless approved by Medical Monitor 3. Active bacterial, viral, or fungal infection requiring systemic therapy. Patients may be re-evaluated for eligibility upon completion of infection treatment. 4. Significant cardiovascular risk (eg, coronary stenting within 4 weeks, myocardial infarction within 6 months) 5. Diagnosis of significant immunodeficiency that in the Investigator or Medical Monitor's judgment would preclude participation in the study. 6. Administration of systemic steroid therapy (\> 10 mg/day of prednisone equivalent) ≤ 7 days prior to the first administration of MT-601 7. Active autoimmune disease that required systemic treatment in the past 2 years (replacement therapies excluded \[eg, thyroxine, insulin, physiologic corticosteroids\]) 8. History of solid organ or hematologic transplant 9. Known HIV 10. Evidence of active hepatitis B as defined by: 1. Positive hepatitis B surface antigen (HBsAg), or 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 11. Evidence of active hepatitis C as defined by: a. Positive anti-hepatitis C virus antibody (HCVAb) with a positive hepatitis C virus (HCV) RNA by PCR 12. Pregnant or currently breast-feeding 13. Psychiatric illness/social situations that would interfere with compliance with study requirements
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas MD Anderson
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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- Blood test aims to catch Cancer's return earlier