Ignite Creation Date:
2025-12-18 @ 8:13 AM
Ignite Modification Date:
2025-12-18 @ 8:13 AM
Study NCT ID:
NCT06066424
Status:
None
Last Update Posted:
2025-10-14 00:00:00
First Post:
2023-09-27 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
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:
None
Organization:
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:
None
Status Verified Date:
2025-10
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:
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-negative/low 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-negative/low 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).
Detailed Description:
None
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?: