NCT07338357

Clinical Study of CLL-1 CAR-T in the Treatment of Children With R/R AML

A Single-Center Clinical Study Evaluating the Safety and Preliminary Efficacy of CLL-1 CAR-T in the Treatment of Children With Relapsed/Refractory Acute Myeloid Leukemia

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: First Affiliated Hospital of Guangxi Medical University · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the safety and preliminary efficacy of CLL-1-targeted CAR-T cell therapy in children aged 3 to 18 years with relapsed or refractory acute myeloid leukemia (r/r AML).

Detailed description

It's a single-center, single-arm, investigator-initiated clinical study. After thorough consideration and signing of the informed consent form by the subject and/or their legal guardian(s), subjects meeting the eligibility criteria during the screening period will provide blood samples for CAR-T manufacturing. Following lymphodepleting chemotherapy, CAR-T cell infusion will be administered on D0.

Conditions

• AML (Acute Myeloid Leukemia)
• CAR-T

Interventions

Type	Name	Description
BIOLOGICAL	CAR-T	A infusion of CLL-1 CAR-T cells following a lymphodepleting chemotherapy regimen.

Timeline

• Start date: 2026-01-05
• Primary completion: 2028-10-31
• Completion: 2028-10-31
• First posted: 2026-01-13
• Last updated: 2026-01-13