NCT07201727

CD123+CLL-1 CAR-T Sequential Infusion With CD7 CAR-T and Bridging to Allo-HSCT for Relapsed/Refractory Acute Myeloid Leukemia

Early Clinical Study of CD123+CLL-1 Dual-target CAR-T Cells Sequential Infusion CD7 CAR-T Cells and Bridging to Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, prospective clinical trial, with patients suffering from refractory and relapsed acute myeloid leukemia as the subjects. It plans to enroll 10 cases to evaluate the safety and efficacy of sequential CD123+CLL-1 CAR-T cells followed by CD7 CAR-T cells treatment.

Detailed description

This study is a single-arm, open-label, prospective clinical trial. It targets patients with relapsed/refractory acute myeloid leukemia (AML), planning to enroll 10 cases. The study will follow up and observe data related to adverse reactions and treatment efficacy after medication, aiming to evaluate the safety and efficacy of sequential therapy with two types of CAR-T cells.

Conditions

• AML - Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CD123+CLL-1 dual-target CAR-T cells sequential infusion CD7 CAR-T cells and bridging to allogeneic	For patients with refractory and relapsed AML, CD123+CLL-1 dual-target CAR-T cells (JY017) are used for treatment. Then, for patients who cannot achieve the minimum residual negative, CD7-targeted CAR-T cells (JY008) are sequentially infused. Finally, allogeneic hematopoietic stem cell transplantation is performed based on patient conditions.

Timeline

• Start date: 2025-09-30
• Primary completion: 2028-05-01
• Completion: 2028-07-01
• First posted: 2025-10-01
• Last updated: 2025-10-01