NCT06064903

CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL

Phase I/II Study of Anti-CD7 Chimeric Antigen Receptor-Expressing T Cells in Pediatric Patients Affected by Relapsed/Refractory CD7+ T-cell Acute Lymphoblastic Leukemia/Lymphoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 6 Months – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CD7-CART01	A single IV infusion of CD7-CART01 on Day 0

Timeline

• Start date: 2024-04-21
• Primary completion: 2028-09-30
• Completion: 2040-09-30
• First posted: 2023-10-03
• Last updated: 2025-12-02

Locations

1 site across 1 country: Italy