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 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT07153068
Brief Summary:
The aim of this study was to evaluate the safety and efficacy of supCD7 CART cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase Ⅰ+Ⅱ clinical trial, two cohorts were set up: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory T-ALL/LBL cohort. Each cohort was planned to enroll 4-12 patients. SupCD7 CART cells will be administered intravenously to explore the MTD of each cohort using a 3+3 dose escalation and rapid titration design.
Detailed Description:
This study will use super-universal CD7 CART cells to treat CD7-positive relapsed or refractory hematological malignancies, especially AML and T-ALL/LBL patients. Two cohorts were established: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory T-ALL/LBL cohort. A 3+3 dose escalation and rapid titration design was used to explore the MTD for each cohort. 3+3 dose escalation CART cells dose groups were (1) 0.5×10\^6 CART cells/kg; (2)1×10\^6 CART cells/kg;(3) 3×10\^6 CART cells/kg. A minimum of 4 and a maximum of 12 patients are expected to be enrolled. Fludarabine and cyclophosphamide-based preconditioning should be performed within 1 week prior to supCD7 CART cells infusion. supCD7 CART cells can be infused at D-1 if the requirement of 24 hours after completion of preconditioning is met. To evaluate the safety and efficacy of supCD7 CART cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies.
Study:
NCT07153068
Study Brief:
Protocol Section:
NCT07153068