MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
NCT Number: NCT06549751
Acronym: PANACEA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pancreas Cancer
Interventions: BIOLOGICAL: MT-601
Sponsor: Marker Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-12

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. Participants will meet all applicable inclusion criteria prior to chemotherapy and must agree to provide apheresis material.

Primary Outcome Measures: During Dose Escalation - assess the safety and tolerability of escalating doses of MT-601 administered during the off week of chemotherapy regimen., * Dose-limiting toxicities (DLTs)
* Safety (including but not limited to): treatment-emergent adverse events, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE, Version 5.0, Through study completion. Approximately 3 years|During Dose Expansion - estimate overall response rate (ORR) of MT-601, To estimate overall response rate (ORR) of MT-601 administered during the off week of chemotherapy regimen (RECIST v1.1) ORR to be measured by disease assessments conducted prior to treatment, at baseline, 8 weeks, 16 weeks and during active follow-up visits which will occur every 8 weeks (starting from Week 24), using RECIST v1.1, Through study completion. Approximately 3 years|During Dose Expansion - estimate duration of response (DOR) of MT-601, To estimate duration of response (DOR)of MT-601 administered during the off week of chemotherapy regimen (RECIST v1.1) DRR to be measured by disease assessments conducted prior to treatment, at baseline, 8 weeks, 16 weeks and during active follow-up visits which will occur every 8 weeks (starting from Week 24), using RECIST v1.1, Through study completion. Approximately 3 years
Secondary Outcome Measures: During Dose Escalation and Dose Expansion - determine the Efficacy of MT-601, To assess anti-tumor activity of MT-601 administered during the off week of chemotherapy regimen based on RECIST v1.1 and overall survival (OS)

* ORR and DOR
* Disease control rate (DCR), time to response (TTR), PFS
* OS, Through study completion. Approximately 3 years|During Dose Expansion - assess safety and tolerability of MT-601, To assess safety and tolerability of MT-601 administered during the off week of chemotherapy regimen

-Safety (including but not limited to): TEAEs, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE Version 5.0, Through study completion. Approximately 3 years
Other Outcome Measures: Exploratory: During Dose Escalation and Dose Expansion - examine the expansion, persistence, clonality and anti-tumor immune effects of the adoptively transferred, autologous MT-601, as well as the presence of epitope spreading in all groups, * Explore markers of immune function, cell targeting, signaling pathways and disease status
* Examine ORR, DOR, DCR, TTR, and PFS based on iRECIST, Through study completion. Approximately 3 years|Exploratory: During Dose Escalation and Dose Expansion - assess anti-tumor activity of MT-601 administered during the off week of chemotherapy regimen based on iRECIST, * Explore markers of immune function, cell targeting, signaling pathways and disease status
* Examine ORR, DOR, DCR, TTR, and PFS based on iRECIST, Through study completion. Approximately 3 years