Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-06 @ 7:05 AM
Study NCT ID:
NCT04625205
Status:
TERMINATED
Last Update Posted:
2025-04-06
First Post:
2020-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma
Sponsor:
BioNTech US Inc.
Organization:
Study Overview
Official Title:
An Open-label, Phase I Study of NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the safety and activity of NEO-PTC-01 in patients with unresectable or metastatic melanoma. NEO-PTC-01 is an autologous personalized T cell (PTC) product for adoptive cell therapy that is manufactured ex vivo and targets neoantigens displayed on the patient's tumor and the tumor microenvironment.
The study will be conducted in two parts, Part 1 (Dose Finding) and Part 2 (Dose Expansion).
The study will be conducted in two parts, Part 1 (Dose Finding) and Part 2 (Dose Expansion).
Detailed Description:
Part 1 will test two doses of NEO-PTC-01 and will be structured according to a 3+3 dose escalation design. After the highest tolerated NEO-PTC-01 dose is identified, 2 additional evaluations in Part 1 are planned to investigate the combination of NEO-PTC-01 with either interleukin (IL) 2-directed or programmed cell death protein 1 (PD-1) inhibitor therapy, respectively.
Part 2 will test the dose deemed to be safe in the dose-finding part of the study to further define the safety of NEO-PTC-01 in patients currently receiving PD-1/ programmed death ligand 1 (PD-L1) inhibitors (as single agent or in combination with cytotoxic T-lymphocyte-associated antigen-4 \[CTLA4\] inhibitors) as first line therapy for metastatic melanoma.
Patients who were treated on previous protocol versions and left the study due to disease progression or who have completed the 52-week follow-up period, may re-enter the study for an extended 5-year follow up in which additional assessments will be conducted.
Part 2 will test the dose deemed to be safe in the dose-finding part of the study to further define the safety of NEO-PTC-01 in patients currently receiving PD-1/ programmed death ligand 1 (PD-L1) inhibitors (as single agent or in combination with cytotoxic T-lymphocyte-associated antigen-4 \[CTLA4\] inhibitors) as first line therapy for metastatic melanoma.
Patients who were treated on previous protocol versions and left the study due to disease progression or who have completed the 52-week follow-up period, may re-enter the study for an extended 5-year follow up in which additional assessments will be conducted.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: