Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05703854
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-01-17
Brief Title:
Study of CAR70-engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Renal Cell Carcinoma Mesothelioma and Osteosarcoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of CAR70-engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Renal Cell Carcinoma Mesothelioma and Osteosarcoma
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 a recommended dose of donated NK cells that can be given with lymphodepleting chemotherapy to patients with advanced renal cell carcinoma mesothelioma or osteosarcoma The effects of this therapy will also be studied
Detailed Description:
Primary Objective
To determine the safety tolerability and optimal cell dose of chimeric antigen receptor CAR70interleukin IL15-transduced cord blood CB-derived natural killer NK cells in patients with advanced renal cell carcinoma advanced mesothelioma and advanced osteosarcoma
To determine the antitumor activity of CAR70IL15-transduced CB-derived NK cells Although the clinical benefit of CAR70IL15-transduced CB-derived NK cells has not yet been established the intent of offering this treatment is to provide a possible therapeutic benefit and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability Efficacy will be determined in each of the three cohorts
Secondary Objectives
To quantify the persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the recipient
To conduct comprehensive immune reconstitution studies
To obtain preliminary data on quality of life and patient experience
To determine the safety tolerability and optimal cell dose of chimeric antigen receptor CAR70interleukin IL15-transduced cord blood CB-derived natural killer NK cells in patients with advanced renal cell carcinoma advanced mesothelioma and advanced osteosarcoma
To determine the antitumor activity of CAR70IL15-transduced CB-derived NK cells Although the clinical benefit of CAR70IL15-transduced CB-derived NK cells has not yet been established the intent of offering this treatment is to provide a possible therapeutic benefit and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability Efficacy will be determined in each of the three cohorts
Secondary Objectives
To quantify the persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the recipient
To conduct comprehensive immune reconstitution studies
To obtain preliminary data on quality of life and patient experience
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-2023-00469 | OTHER | NCI-CTRP Clinical Trial Registry | None |