Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT07285668
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.
Study:
NCT07285668
Study Brief:
Protocol Section:
NCT07285668