Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:52 AM
Study NCT ID:
NCT07444632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/Refractory Lymphoid Malignancies
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/Refractory Lymphoid Malignancies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
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:
This is a phase 1 basket trial of TGFBR2 KO CAR27/IL-15 NK cells after lymphodepleting chemotherapy for patients with R/R B-NHL, HL, T-NHL or B-ALL.
Detailed Description:
Primary Objective:
To establish the safety of TGFBR2 KO CAR27/IL-15 NK cells in patients with R/R lymphomas and B-ALL through the following primary endpoints
* To determine the recommended phase 2 dose (RP2D) of this treatment.
* To define the dose-limiting toxicity (DLT) of this treatment.
Secondary Objectives:
1. To observe and record anti-tumor activity through the following secondary endpoints:
* Day+ 30 complete response (CR) rate.
* Day +30 overall response rate (ORR).
* Day 180 progression-free survival rate
2. To quantify the persistence of infused donor TGFBR2 KO CAR27/IL-15 NK cells in the recipient.
3. To conduct comprehensive immune reconstitution studies.
4. To obtain preliminary data on quality of life (QOL) and patient experience
To establish the safety of TGFBR2 KO CAR27/IL-15 NK cells in patients with R/R lymphomas and B-ALL through the following primary endpoints
* To determine the recommended phase 2 dose (RP2D) of this treatment.
* To define the dose-limiting toxicity (DLT) of this treatment.
Secondary Objectives:
1. To observe and record anti-tumor activity through the following secondary endpoints:
* Day+ 30 complete response (CR) rate.
* Day +30 overall response rate (ORR).
* Day 180 progression-free survival rate
2. To quantify the persistence of infused donor TGFBR2 KO CAR27/IL-15 NK cells in the recipient.
3. To conduct comprehensive immune reconstitution studies.
4. To obtain preliminary data on quality of life (QOL) and patient experience
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2026-01395 | OTHER | NCI-CTRP Clinical Trials Registry | View |