Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06066424
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-09-27
Brief Title:
Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Patients With Advanced Solid Tumors TROPIKANA
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 IL15-transduced Cord Blood-derived NK Cells in Patients With Advanced Solid Tumors TROPIKANA
Status:
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 recommended dose of TROP2- CAR-NK cells that can be given to participants with advanced forms of solid tumors
Detailed Description:
Primary Objective
1 To determine the safety tolerability optimal cell dose OCD maximum tolerated dose MTD and recommended Phase 2 dose RP2D of TROP2-CAR-NK cells in participants with solid tumors with high TROP2 expression
Secondary Objectives
1 To determine the antitumor activity of TROP2-CAR-NK cells in participants with high TROP2-expressing NSCLC and high TROP2-expressing HER2-negativelow breast
cancer Although the clinical benefit of TROP2-CAR-NK cells has not yet been established the intent of offering this treatment is to provide a possible therapeutic benefit and thus the participant will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability
2 To quantify the persistence of infused allogeneic donor TROP2-CAR-NK cells in the peripheral blood of the recipient
3 To evaluate tissue and blood-based biomarkers associated with response and resistance to TROP2-CAR-NK cell infusion
Exploratory Objectives
1 To profile and assess dynamic changes in the tumor microenvironment
2 To evaluate longitudinal changes in circulating tumor DNA ctDNA
1 To determine the safety tolerability optimal cell dose OCD maximum tolerated dose MTD and recommended Phase 2 dose RP2D of TROP2-CAR-NK cells in participants with solid tumors with high TROP2 expression
Secondary Objectives
1 To determine the antitumor activity of TROP2-CAR-NK cells in participants with high TROP2-expressing NSCLC and high TROP2-expressing HER2-negativelow breast
cancer Although the clinical benefit of TROP2-CAR-NK cells has not yet been established the intent of offering this treatment is to provide a possible therapeutic benefit and thus the participant will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability
2 To quantify the persistence of infused allogeneic donor TROP2-CAR-NK cells in the peripheral blood of the recipient
3 To evaluate tissue and blood-based biomarkers associated with response and resistance to TROP2-CAR-NK cell infusion
Exploratory Objectives
1 To profile and assess dynamic changes in the tumor microenvironment
2 To evaluate longitudinal changes in circulating tumor DNA ctDNA
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-2023-08351 | OTHER | NCI-CTRP Clinical Trials Registry | None |