What this study is
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.
What's being tested
- MT-601 dose 200 million cells
Intervention · DRUG
MT-601 Dose 200 million cells
- MT-601 dose 400 million cells
Intervention · DRUG
MT-601 Dose 400 million cells
- MT-601 dose 800 million cells
Intervention · DRUG
MT-601 Dose 800 million cells
- MT-601 dose 1200 million cells
Intervention · DRUG
MT-601 Dose 1200 million cells
Study details
- 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)
- Sponsor
- Marker Therapeutics, Inc.
- Conditions
- Pancreas Cancer · Pancreatic Cancer Metastatic · Pancreatic Cancer (Unresectable)
- Enrolling
- 38 people
- Starts
- 2026-07-16
- Est. completion
- 2028-09-16
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
- 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
You can't join if
- 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
- 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: a. 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe University of Texas MD Anderson
Houston, Texas, United States
Study team
Sponsor
Marker Therapeutics, Inc.
Study ID MRKR-22-601-02
Study director
Patricia Allison, BS
Marker Therapeutics
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.