MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer (PANACEA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer Metastatic; Pancreas Cancer; Pancreatic Cancer (Unresectable)
• Intervention / Treatment: Drug: MT-601 dose 400 million cells; Drug: MT-601 dose 1200 million cells; Drug: MT-601 dose 800 million cells; Drug: MT-601 dose 200 million cells

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 Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Patricia Allison, BS; Phone Number: 7174715205; Email: pallison@markertherapeutics.com
• Study Contact Backup: Name: Kaylor Hopkins; Phone Number: (817) 395-2275

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 / MT-601 dose 400 million cells; MT-601 dose 400 million cells	Drug: MT-601 dose 400 million cells; MT-601 Dose 400 million cells
Experimental: Cohort 3 / MT-601 1200 million cells; MT-601 dose 1200 million cells	Drug: MT-601 dose 1200 million cells; MT-601 Dose 1200 million cells
Experimental: Cohort 2 / MT-601 800 million cells; MT-601 dose 800 million cells	Drug: MT-601 dose 800 million cells; MT-601 Dose 800 million cells
Experimental: Cohort -1 / MT-601 dose 200 million cells; Experimental: Cohort -1 / MT-601 dose 200 million cells	Drug: MT-601 dose 200 million cells; MT-601 Dose 200 million cells
Experimental: Dose Expansion; The Dose Expansion portion will begin after completion of the Dose Escalation portion with recommended dose of MT-601.	Drug: MT-601 dose 400 million cells; MT-601 Dose 400 million cells; Drug: MT-601 dose 1200 million cells; MT-601 Dose 1200 million cells; Drug: MT-601 dose 800 million cells; MT-601 Dose 800 million cells; Drug: MT-601 dose 200 million cells; MT-601 Dose 200 million cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	Through study completion. Approximately 2.5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: During Dose Escalation and Dose Expansion - evaluate the relationship between potential biomarkers and response	Changes in mRNA-seq over time; Changes in CA19-9 over time	Through study completion. Approximately 2.5 years
Exploratory: During Dose Escalation and Dose Expansion - evaluate improvement in response rate with administration of MT-601	- Examine Overall Response Rate (ORR)	Through study completion. Approximately 2.5 years
During Dose Escalation and Dose Expansion evaluate survival rates	One-year survival; Overall survival (OS)	through study completion - approximately 2.5 years

Collaborators and Investigators

• Sponsor: Marker Therapeutics, Inc.
• Collaborators: M.D. Anderson Cancer Center
• Investigators: Study Director: Patricia Allison, BS, Marker Therapeutics

Study record dates

Study Major Dates

• Study Start (Estimated): July 16, 2026
• Primary Completion (Estimated): July 16, 2028
• Study Completion (Estimated): September 16, 2028

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: MRKR-22-601-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD sharing plan will be developed if it is decided that the results of this study may be published or presented at scientific meetings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No