Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-05 @ 12:43 AM
Study NCT ID:
NCT07285668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Phase I Study of Prophylactic TCRαβ+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to assess the safety and determine the maximum tolerable dose (MTD) of TCRαβ+/CD19+-depleted Donor Lymphocyte Infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in highrisk patients with hematologic malignancies.
Detailed Description:
Primary Objectives
* To assess safety of prophylactic TCRαβ+/CD19+ depleted donor lymphocyte infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in high-risk patients with hematologic malignancies
* To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of αβT/B dep-DLI
Secondary Objectives
* To assess the feasibility of αβT/B dep-DLI
* To assess additional safety parameters after αβT/B dep-DLI
* To assess the efficacy of αβT/B dep-DLI
For the dose escalation phase: Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD) is defined as the highest dose level where less than 2 of 6 participants experience a dose limiting toxicity (DLT).
Each dose level will be followed for DLTs until day 28 post donor lymphocyte infusion (DLI). Starting at dose level 1:
* If 0 of 3 participants experiences DLT, increase to next dose level for next 3 participants.
* If 1 of 3 participants experience DLT, enroll 3 participants at same dose level.
* If no additional DLTs (1 of 6), move on to next dose level.
* If 2 of 6 participants experience DLT, enroll 3 participants into lower dose level.
* If 0 or 1 participants experience DLT at lower level, this will be the MTD.
Once the MTD or MAD is determined, an expansion cohort will be enrolled into that dose level.
All participants will be followed for 2 years after DLI.
* To assess safety of prophylactic TCRαβ+/CD19+ depleted donor lymphocyte infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in high-risk patients with hematologic malignancies
* To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of αβT/B dep-DLI
Secondary Objectives
* To assess the feasibility of αβT/B dep-DLI
* To assess additional safety parameters after αβT/B dep-DLI
* To assess the efficacy of αβT/B dep-DLI
For the dose escalation phase: Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD) is defined as the highest dose level where less than 2 of 6 participants experience a dose limiting toxicity (DLT).
Each dose level will be followed for DLTs until day 28 post donor lymphocyte infusion (DLI). Starting at dose level 1:
* If 0 of 3 participants experiences DLT, increase to next dose level for next 3 participants.
* If 1 of 3 participants experience DLT, enroll 3 participants at same dose level.
* If no additional DLTs (1 of 6), move on to next dose level.
* If 2 of 6 participants experience DLT, enroll 3 participants into lower dose level.
* If 0 or 1 participants experience DLT at lower level, this will be the MTD.
Once the MTD or MAD is determined, an expansion cohort will be enrolled into that dose level.
All participants will be followed for 2 years after DLI.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: