MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarker Therapeutics, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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)
Trial design
Treatments tested in this trial
- MT-601 dose 200 million cells
- MT-601 dose 400 million cells
- MT-601 dose 800 million cells
- MT-601 dose 1200 million cells
Treatment groups
38 Participants
are divided into 5 treatment groupsSponsors and collaborators
Marker Therapeutics, Inc.
Lead sponsor
M.D. Anderson Cancer Center
Collaborator
Source ClinicalTrials.gov