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

Part of paid clinical trials in Houston, Texas.

Sponsor
Marker Therapeutics, Inc.
Study ID
NCT06549751
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Pancreas Cancer
  • Pancreatic Cancer (Unresectable)
  • Pancreatic Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MT-601 dose 200 million cells — DRUG
    MT-601 Dose 200 million cells
  • MT-601 dose 400 million cells — DRUG
    MT-601 Dose 400 million cells
  • MT-601 dose 800 million cells — DRUG
    MT-601 Dose 800 million cells
  • MT-601 dose 1200 million cells — DRUG
    MT-601 Dose 1200 million cells

Study Details

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.

Key Dates

Start date
Jul 16, 2026
Status verified
Apr 2026
Primary completion
Jul 16, 2028
Completion
Sep 16, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 / 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
  • Experimental: Cohort 2 / MT-601 800 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
  • Experimental: Dose Expansion
    The Dose Expansion portion will begin after completion of the Dose Escalation portion with recommended dose of MT-601.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas MD AndersonHoustonTexas77030-

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