Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358430
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-05
Brief Title:
Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer CRC With Minimal Residual Disease MRD
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer CRC With Minimal Residual Disease MRD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
To find the highest andor recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC
Detailed Description:
Primary Objective
1 To determine the safety tolerability maximum tolerated dose MTD and recommended Phase 2 dose RP2D of TROP2-CAR-NK cells combined with cetuximab in patients with MRD CRC
2 To evaluate circulating tumor DNA ctDNA clearance undetectable at 3 months
Secondary Objectives
1 Determine progression-free survival
2 To quantify the persistence of infused allogeneic donor TROP2-CAR-NK cells in the peripheral blood of the recipient
3 To evaluate blood- and tissue-based biomarkers at baseline associated with response and resistance to TROP2-CAR-NK cell infusion in combination with cetuximab
Exploratory Objectives
1 To profile and assess dynamic immune changes in the tumor microenvironment
2 Quantify the average circulating ctDNA change from TROP2-CAR-NK infusion to progression or initiation of a new cancer therapy and association with PFS
3 To evaluate patient-reported quality of life QoL
1 To determine the safety tolerability maximum tolerated dose MTD and recommended Phase 2 dose RP2D of TROP2-CAR-NK cells combined with cetuximab in patients with MRD CRC
2 To evaluate circulating tumor DNA ctDNA clearance undetectable at 3 months
Secondary Objectives
1 Determine progression-free survival
2 To quantify the persistence of infused allogeneic donor TROP2-CAR-NK cells in the peripheral blood of the recipient
3 To evaluate blood- and tissue-based biomarkers at baseline associated with response and resistance to TROP2-CAR-NK cell infusion in combination with cetuximab
Exploratory Objectives
1 To profile and assess dynamic immune changes in the tumor microenvironment
2 Quantify the average circulating ctDNA change from TROP2-CAR-NK infusion to progression or initiation of a new cancer therapy and association with PFS
3 To evaluate patient-reported quality of life QoL
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03107 | OTHER | NCI-CTRP Clinical Registry | None |