Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469281
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-06
Brief Title:
A Study to Learn if 27T51 a Mucin-16 MUC16 Protein Targeting Immune Cell Therapy Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Phase 1a1b Study of 27T51 an Anti-MUC16 CAR T Cell Drug Product Administered Alone or in Combination for Participants With Recurrent or Refractory Epithelial Ovarian Primary Peritoneal or Fallopian Tube Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is researching an experimental CAR T cell therapy called 27T51 referred to as study drug The study drug is a MUC16 targeting immune cell therapy focused on adult female participants with recurrent or difficult to treat epithelial ovarian primary peritoneal or fallopian tube cancer
This study has two 2 major parts
Phase 1a Dose Escalation and Phase 1b Dose Expansion The aim of the dose escalation part will be to test the safety of 27T51 in a small number of participants to find the highest dose given to humans without unacceptable side effects The aim of the dose expansion part will be to test 27T51 at the established dose levels from the dose escalation part and may include other medications given in combination with 27T51
Information collected from this study will help researchers understand more fully whether this immune cell therapy also known as CAR T cell therapy can be safely used to treat solid tumors such as ovarian cancer
This study has two 2 major parts
Phase 1a Dose Escalation and Phase 1b Dose Expansion The aim of the dose escalation part will be to test the safety of 27T51 in a small number of participants to find the highest dose given to humans without unacceptable side effects The aim of the dose expansion part will be to test 27T51 at the established dose levels from the dose escalation part and may include other medications given in combination with 27T51
Information collected from this study will help researchers understand more fully whether this immune cell therapy also known as CAR T cell therapy can be safely used to treat solid tumors such as ovarian cancer
Detailed Description:
Former Sponsor 2seventy bio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None