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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07444632
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
Study:
NCT07444632
Study Brief:
Protocol Section:
NCT07444632