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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT06064903
Brief Summary:
The main purpose of this study is to evaluate the safety, to establish the recommended dose, and to evaluate the antitumor effect of CD7-CART01 in pediatric patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LL).
Detailed Description:
This is an in-human, open-lable, single-arm, single-agent, Phase 1/2 study in pediatric patients with R/R T-ALL/T-LL who have failed at least one standard frontline chemotherapy or relapsed after allogeneic hematopoietic stem cell transplantation (HSCT). The study will consist of two phases, Phase 1 and Phase 2. During the Dose Escalation portion of the trial (Phase 1) up to 12 patients will receive CD7-CART01, in up to 2 dose levels until maximum tolerated dose (MTD) is determined. If 2 DLTs are observed in the dose level 1 an additional DL0 will be explored. The dose escalation phase will enroll successive cohorts of 3 up to 6 patients guided by a standard dose-finding 3 + 3 design. Once the recommended phase 2 dose (RP2D) is defined, the phase 2 portion of the study will enroll at the MTD/RD identified in the phase I up to 26 pediatric patients (for both phases) and the study protocol will be amended to include additional, international centers.
Study:
NCT06064903
Study Brief:
Protocol Section:
NCT06064903