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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
MT-601 dose 200 million cells
DrugMT-601 Dose 200 million cells
MT-601 dose 400 million cells
DrugMT-601 Dose 400 million cells
MT-601 dose 800 million cells
DrugMT-601 Dose 800 million cells
MT-601 dose 1200 million cells
DrugMT-601 Dose 1200 million cells
Treatment groups
38 Participants
are divided into 5 treatment groupsGroup A: Cohort 1 / MT-601 dose 400 million cellsExperimental treatment 1 intervention
Group B: Cohort 3 / MT-601 1200 million cellsExperimental treatment 1 intervention
Group C: Cohort 2 / MT-601 800 million cellsExperimental treatment 1 intervention
Group D: Cohort -1 / MT-601 dose 200 million cellsExperimental treatment 1 intervention
Group E: Dose ExpansionExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
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).
Dose-limiting toxicities (DLTs)
Time frame
Through study completion. Approximately 24 monthsSecondary outcomes
1
During Dose Expansion - evaluate the safety profile of MT-601
To evaluate the safety profile of MT-601 administered during maintenance capecitabine following treatment with FFX or NLX -Safety (including but not limited to): TEAEs, SAEs, and deaths
Time frame
Through study completion. Approximately 2.5 years2
During Dose Escalation and Dose Expansion - determine the Efficacy of MT-601
Evaluate the efficacy of MT-601 administered during maintenance capecitabine following treatment with FFX or NLX with the endpoints of Progression Free Survival (PFS) and Duration of Response (DOR).
Time frame
Through study completion. Approximately 2.5 yearsOther outcomes
1
Exploratory: During Dose Escalation and Dose Expansion - evaluate the relationship between potential biomarkers and response
* Changes in mRNA-seq over time * Changes in CA19-9 over time
Time frame
Through study completion. Approximately 2.5 years2
Exploratory: During Dose Escalation and Dose Expansion - evaluate improvement in response rate with administration of MT-601
\- Examine Overall Response Rate (ORR)
Time frame
Through study completion. Approximately 2.5 years3
During Dose Escalation and Dose Expansion evaluate survival rates
* One-year survival * Overall survival (OS)
Time frame
through study completion - approximately 2.5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Marker Therapeutics, Inc.
Lead sponsor
M.D. Anderson Cancer Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: