Pancreas CancerPhase 1PANACEANCT06549751
MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
A Phase 1 study testing MT-601 dose 200 million cells, MT-601 dose 400 million cells and MT-601 dose 800 million cells in people with Pancreas Cancer and Pancreatic Cancer Metastatic, run by Marker Therapeutics, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreatic Cancer Metastatic, Pancreatic Cancer (Unresectable)
- What is being tested?
- MT-601 dose 200 million cells, MT-601 dose 400 million cells and MT-601 dose 800 million cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2026to 16 Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent
- Age ≥ 18 years
- ECOG performance status of 0 to 1
- Cytologically or histologically confirmed, locally advanced, unresectable or metastatic pancreatic adenocarcinoma (pancreatic carcinomas with at least some component of adenocarcinoma included).
- Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Prior receipt of at least 4 doses (~2 months) of FFX or NLX with plans for completion of 12 doses (~6 months)
Show all 17Show fewer
- Absence of progression during treatment with FFX or NLX (eg. CR, PR, or SD at study entry)
- Adequate pulmonary function with partial pressure of oxygen (pO2) on room air of at least 90%
- Adequate cardiac function with an ejection fraction ≥ 45%
- 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
- Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of any study drugs
Who cannot join
- 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
- Other known active cancer likely to require additional treatment in the next 2 years unless approved by Medical Monitor
- Active bacterial, viral, or fungal infection requiring systemic therapy. Patients may be re-evaluated for eligibility upon completion of infection treatment.
- Significant cardiovascular risk (eg, coronary stenting within 4 weeks, myocardial infarction within 6 months)
- Diagnosis of significant immunodeficiency that in the Investigator or Medical Monitor's judgment would preclude participation in the study.
- Administration of systemic steroid therapy (> 10 mg/day of prednisone equivalent) ≤ 7 days prior to the first administration of MT-601
Show all 16Show fewer
- Active autoimmune disease that required systemic treatment in the past 2 years (replacement therapies excluded [eg, thyroxine, insulin, physiologic corticosteroids])
- History of solid organ or hematologic transplant
- Known HIV
- Evidence of active hepatitis B as defined by:
- Positive hepatitis B surface antigen (HBsAg), or
- 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
- Evidence of active hepatitis C as defined by:
- Positive anti-hepatitis C virus antibody (HCVAb) with a positive hepatitis C virus (HCV) RNA by PCR
- Pregnant or currently breast-feeding
- Psychiatric illness/social situations that would interfere with compliance with study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kaylor Hopkins contact
United States1 site
The University of Texas MD Anderson
Houston, Texas, 77030
About this study
Official title: 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)
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.
Read the detailed description
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/nab-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.
- Being tested
- MT-601 dose 200 million cells, MT-601 dose 400 million cells, MT-601 dose 800 million cells, MT-601 dose 1200 million cells
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-601 dose 200 million cellsDrug
MT-601 Dose 200 million cells
MT-601 dose 400 million cellsDrug
MT-601 Dose 400 million cells
MT-601 dose 800 million cellsDrug
MT-601 Dose 800 million cells
MT-601 dose 1200 million cellsDrug
MT-601 Dose 1200 million cells
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 / MT-601 dose 400 million cells | Experimental | MT-601 dose 400 million cells Receives: Drug: MT-601 dose 400 million cells |
| Cohort 3 / MT-601 1200 million cells | Experimental | MT-601 dose 1200 million cells Receives: Drug: MT-601 dose 1200 million cells |
| Cohort 2 / MT-601 800 million cells | Experimental | MT-601 dose 800 million cells Receives: Drug: MT-601 dose 800 million cells |
| Cohort -1 / MT-601 dose 200 million cells | Experimental | Experimental: Cohort -1 / MT-601 dose 200 million cells Receives: Drug: MT-601 dose 200 million cells |
| Dose Expansion | Experimental | The Dose Expansion portion will begin after completion of the Dose Escalation portion with recommended dose of MT-601. Receives: Drug: MT-601 dose 200 million cells; Drug: MT-601 dose 400 million cells; Drug: MT-601 dose 800 million cells; Drug: MT-601 dose 1200 million cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Through study completion. Approximately 24 months
Secondary outcomes (2)
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
-Safety (including but not limited to): TEAEs, SAEs, and deaths
Measured: Through study completion. Approximately 2.5 years
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).
Measured: Through study completion. Approximately 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start16 Jul 2026 (estimated)
- Primary completion16 Jul 2028 (estimated)
- Study completion16 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marker Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Patricia Allison, BS, Study director, Marker Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549751
- Sponsor's protocol ID
- MRKR-22-601-02
- Acronym
- PANACEA
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing plan will be developed if it is decided that the results of this study may be published or presented at scientific meetings.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06549751
- Acronym / sponsor ID
- PANACEA / MRKR-22-601-02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Marker Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 16 Jul 2026 (estimated)
- Primary completion
- 16 Jul 2028 (estimated)
- Study completion
- 16 Sep 2028 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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/nab-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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 / MT-601 dose 400 million cells | Experimental | Drug: MT-601 dose 400 million cellsMT-601 dose 400 million cells |
| Cohort 3 / MT-601 1200 million cells | Experimental | Drug: MT-601 dose 1200 million cellsMT-601 dose 1200 million cells |
| Cohort 2 / MT-601 800 million cells | Experimental | Drug: MT-601 dose 800 million cellsMT-601 dose 800 million cells |
| Cohort -1 / MT-601 dose 200 million cells | Experimental | Drug: MT-601 dose 200 million cellsExperimental: Cohort -1 / MT-601 dose 200 million cells |
| Dose Expansion | Experimental | Drug: MT-601 dose 200 million cells, Drug: MT-601 dose 400 million cells, Drug: MT-601 dose 800 million cells, Drug: MT-601 dose 1200 million cellsThe Dose Expansion portion will begin after completion of the Dose Escalation portion with recommended dose of MT-601. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Informed Consent
- Age ≥ 18 years
- ECOG performance status of 0 to 1
- Cytologically or histologically confirmed, locally advanced, unresectable or metastatic pancreatic adenocarcinoma (pancreatic carcinomas with at least some component of adenocarcinoma included).
- Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Key exclusion criteria (16 listed)
- 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
- Other known active cancer likely to require additional treatment in the next 2 years unless approved by Medical Monitor
- Active bacterial, viral, or fungal infection requiring systemic therapy. Patients may be re-evaluated for eligibility upon completion of infection treatment.
- Significant cardiovascular risk (eg, coronary stenting within 4 weeks, myocardial infarction within 6 months)
- Diagnosis of significant immunodeficiency that in the Investigator or Medical Monitor's judgment would preclude participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-601 dose 200 million cellsMT-601 Dose 200 million cells | Drug | Cohort -1 / MT-601 dose 200 million cells, Dose Expansion |
| MT-601 dose 400 million cellsMT-601 Dose 400 million cells | Drug | Cohort 1 / MT-601 dose 400 million cells, Dose Expansion |
| MT-601 dose 800 million cellsMT-601 Dose 800 million cells | Drug | Cohort 2 / MT-601 800 million cells, Dose Expansion |
| MT-601 dose 1200 million cellsMT-601 Dose 1200 million cells | Drug | Cohort 3 / MT-601 1200 million cells, Dose Expansion |
Primary outcome
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).
Time frame: Through study completion. Approximately 24 months
Dose-limiting toxicities (DLTs)
2 secondary outcomes
During Dose Expansion - evaluate the safety profile of MT-601
Time frame: Through study completion. Approximately 2.5 years
During Dose Escalation and Dose Expansion - determine the Efficacy of MT-601
Time frame: Through study completion. Approximately 2.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. IPD sharing plan will be developed if it is decided that the results of this study may be published or presented at scientific meetings.
Related trials for Pancreas Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaylor Hopkins contact
Patricia Allison, BS study director
Marker Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-601 dose 200 million cells, MT-601 dose 400 million cells and MT-601 dose 800 million cells in people with Pancreas Cancer and Pancreatic Cancer Metastatic, run by Marker Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Allison, BS (7174715205, pallison@markertherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Through study completion. Approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.