Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474676
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-20
Brief Title:
T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy attIL12-TIL for AdvancedMetastatic Soft Tissue and Bone Sarcoma Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy attIL12-TIL for AdvancedMetastatic Soft Tissue and Bone Sarcoma Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 attIL2-TIL cell therapy that can be given to participant with either relapsed or metastatic sarcomas has come back or spread to other parts of the body respectively
To further test the dose found in Part A to see if it can help to control liposarcoma growth
To further test the dose found in Part A to see if it can help to control liposarcoma growth
Detailed Description:
Primary Objectives Part A Determine the safety maximum tolerated dose andor recommended phase 2 dose of T cell membrane-anchored tumor- targeted IL12 attIL12-TIL cell therapy in combination with cyclophosphamide in participants with advancedmetastatic soft tissue or bone sarcomas Part B Characterize the safety and tolerability and assess preliminary efficacy of attIL12 TIL cells in combination with cyclophosphamide by evaluating the 4-month progression free survival rate PFS 4 months in participants with recurrent unresectable liposarcoma
Secondary Objectives
1 Evaluate the anti-tumor efficacy achieved following adoptive transfer of T cell membrane- anchored tumor- targeted IL12 attIL12-TIL cell therapy in combination with cyclophosphamide in participants with advancedmetastatic soft tissue or bone sarcomas
Exploratory Objectives
1 Characterize the immune response following adoptive transfer of attIL12 TIL cell therapy in paired in pre-treatment and on-treatment tumor specimens and peripheral blood samples
2 Assess collagen and FAP changes in pre-treatment and on-treatment tumor specimens and correlate with clinical benefitanti-tumor response
3 Determine changes in cell surface vimentin CSV-positive circulating tumor cells CTCs in peripheral blood before and after adoptive transfer of T cell membrane-anchored tumor- targeted IL12 attIL12-TIL cell therapy and correlate with clinical benefitanti-tumor response
Secondary Objectives
1 Evaluate the anti-tumor efficacy achieved following adoptive transfer of T cell membrane- anchored tumor- targeted IL12 attIL12-TIL cell therapy in combination with cyclophosphamide in participants with advancedmetastatic soft tissue or bone sarcomas
Exploratory Objectives
1 Characterize the immune response following adoptive transfer of attIL12 TIL cell therapy in paired in pre-treatment and on-treatment tumor specimens and peripheral blood samples
2 Assess collagen and FAP changes in pre-treatment and on-treatment tumor specimens and correlate with clinical benefitanti-tumor response
3 Determine changes in cell surface vimentin CSV-positive circulating tumor cells CTCs in peripheral blood before and after adoptive transfer of T cell membrane-anchored tumor- targeted IL12 attIL12-TIL cell therapy and correlate with clinical benefitanti-tumor response
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-2024-05385 | OTHER | None | None |