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

Study Overview

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

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.

The Dose Escalation portions will proceed using a standard 3+3 design. Flat doses of MT-601 will be administered ranging from 200 million cells to 400 million cells. 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 10 minutes (± 5 minutes) during the "off" week of front-line chemotherapy. Patients will receive up to 6 infusions of MT-601 approximately every 4 weeks.

Pancreas Cancer

BIOLOGICAL: MT-601

MRKR-22-601-02

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-06-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-08-08
First Submitted that Met QC Criteria 2024-08-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-08-12
First Posted (ACTUAL) 2024-08-12	Results First Posted N/A	Last Verified 2024-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Escalation Cohort -1 / 100 million cells / 3-6 patients Cohort 1 / 200 million cells / 3-6 patients Cohort 1 / 400 million cells / 3-6 patients	BIOLOGICAL: MT-601 Cellular Therapy
EXPERIMENTAL: Expansion The Dose Expansion portion will begin after completion of the Dose Escalation portion and focus on the efficacy of MT-601 as add-on to front-line chemotherapy. The dose level for the expansion portion of the study will be selected based on totality of the	BIOLOGICAL: MT-601 Cellular Therapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Escalation

Cohort -1 / 100 million cells / 3-6 patients Cohort 1 / 200 million cells / 3-6 patients Cohort 1 / 400 million cells / 3-6 patients

BIOLOGICAL: MT-601

Cellular Therapy

EXPERIMENTAL: Expansion

The Dose Expansion portion will begin after completion of the Dose Escalation portion and focus on the efficacy of MT-601 as add-on to front-line chemotherapy. The dose level for the expansion portion of the study will be selected based on totality of the

BIOLOGICAL: MT-601

Cellular Therapy

Primary Outcome Measures	Measure Description	Time Frame
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	Measure Description	Time Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Patricia Allison, BS

Phone Number: 7174715205

Email: pallison@markertherapeutics.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Absolute neutrophil count (ANC) ≥1.5 × 109/L
Platelets ≥75 × 109/L
Hemoglobin ≥9 g/dL (can be transfused)
International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × upper limit of normal (ULN) (unless patient receiving stable dose of anticoagulant therapy as long as PT or INR in therapeutic range of intended anticoagulant)
Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) PTT or aPTT ≤ 5 seconds above ULN (unless patient receiving stable dose of anticoagulant therapy "a" as long as PT or INR in therapeutic range of intended anticoagulant)
Total bilirubin ≤2 × ULN
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN OR ≤5 × ULN if liver has tumor involvement
Serum creatinine OR calculated (as per institutional standards) creatinine clearance ≤2 × ULN OR measured or calculated ≥50 mL/min for patients "a" If receiving anticoagulation, the patient must have no active bleeding within 14 days prior to baseline assessment. 10. Sexually active patients must be willing to utilize one of the highly effective birth control methods or practice complete abstinence between initiation of screening for MT-601 infusion and 6 months after the last MT-601 infusion. Male patients who are sexually active must agree to use a condom during this period. 11. Disease imaging prior to administration of front-line chemotherapy and reimaging prior to administration of MT-601.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Patricia Allison, BS, Marker Therapeutics

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record