Viewing Study NCT05922930



Ignite Creation Date: 2024-05-06 @ 7:12 PM
Last Modification Date: 2024-10-26 @ 3:02 PM
Study NCT ID: NCT05922930
Status: RECRUITING
Last Update Posted: 2024-06-14
First Post: 2023-06-20

Brief Title: Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells Delivered Intraperitoneally for the Management of Platinum Resistant Ovarian Cancer Mesonephric-like Adenocarcinoma and Pancreatic Cancer
Sponsor: MD Anderson Cancer Center
Organization: MD Anderson Cancer Center

Study Overview

Official Title: Phase III Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells Delivered Intraperitoneally for the Management of Platinum Resistant Ovarian Cancer Mesonephric-like Adenocarcinoma and Pancreatic Cancer
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 given intraperitoneally directly into the abdominal cavity to patients with highgrade serous ovarian cancer that has not responded to previous treatment or is resistant to treatment
Detailed Description: Primary Objectives

1 To determine the safety and optimal cell dose of TROP2-CARIL15-transduced CB-NK cells delivered intraperitoneally and define the MTDRP2D Endpoints

1 Dose-limiting toxicity
2 Optimal TROP2-CARIL15-transduced CB-NK cell dose

Secondary Objectives and Endpoints

Objectives

1 To estimate the best objective response rate ORR in patients at 12 weeks after infusion
2 To estimate median progression free survival
3 To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the peripheral blood and peritoneal cavity in the recipient
4 To profile and assess the dynamic changes in the peritoneal tumor microenvironment before and after treatment using single-cell transcriptional and immune profiling on peritoneal cells at various time points before and after treatment
5 To estimate patient reported symptom burden and quality of life longitudinally through treatment and follow up
6 To compare changes in circulating tumor DNA ctDNA with response as determined by RECIST v11

Endpoints

1 Objective response rates at week 12
2 Median progression free survival
3 TROP2-CAR NK cell numbers in peripheral blood and peritoneal cavity vs time profile
4 Characterization of lymphocyte populations at various time points
5 PROMIS-19 EQ-5D-5L and MDASI-OC PRO questionnaire responses
6 Plasma ctDNA concentration at baselines and serial timepoint

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-2023-05027 OTHER NCI-CTRP Clinical Trials Registry None