Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549751
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-06
Brief Title:
MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study Of Patient-Derived Multi-Tumor-Associated Antigen Specific T Cells MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANACEA
Brief 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 questions 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
Detailed Description:
The Dose Escalation portions will proceed using a standard 33 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 gemcitabinenab-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None