NCT07336875

Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory/Relapsed AML

Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory/Relapsed Acute Myeloid Leukemia

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to evaluate the safety and efficacy of CAR-ITNK cells therapy targeting CD70 and CLL1 in participants with relapsed/refractory Acute Myeloid Leukemia. Participants will receive a single infusion of CAR-ITNK cell therapy targeting CD70 and CLL1 and complete follow-ups over the next three years.

Detailed description

Acute myeloid leukemia (AML) is a hematological malignancy disease originating from the bone marrow, typically presenting with acute onset, and patients may experience symptoms such as anemia, bleeding, and infections. The main treatment modalities currently include chemotherapy, targeted drug therapy, and hematopoietic stem cell transplantation. In addition to its low cure rate, AML has a high recurrence rate, is prone to developing resistance to chemotherapy drugs, and can easily lead to severe side effects, such as infections and bone marrow suppression. Therefore, there is an urgent need to find new therapeutic approaches for treating acute myeloid leukemia. The research team at Guangdong Zhaotai Cell Biotechnology Co., Ltd. has independently developed and constructed a novel tandem CAR-ITNK cell targeting CD70 and CLL1. In vitro cytotoxicity assay data show that the activity of the tandem CAR-ITNK cells targeting both CD70 and CLL1 (CAR70C1-ITNK) in killing CD70- and CLL1-overexpressing cells is stronger than that of single-targeted CAR-ITNK cells against either CD70 or CLL1. In vivo xenograft mouse models using THP-1 cells demonstrate that the ability of CAR70C1-ITNK cells to kill THP-1 cells is superior to that of single-targeted CD70 CAR-ITNK cells. These experimental data indicate the potential value of the novel tandem CAR-ITNK cells targeting CD70 and CLL1 in clinically treating patients with refractory/relapsed acute myeloid leukemia. This clinical trial proposes to use the novel tandem CAR-ITNK cells targeting CD70 and CLL1 as an interventional measure for subjects with refractory/relapsed acute myeloid leukemia. After treatment with these novel tandem CAR-ITNK cells, the safety and preliminary efficacy will be evaluated through various assessment methods, including clinical symptom evaluation, biomarker testing, laboratory tests, imaging assessments, adverse event monitoring, and follow-up surveys.

Conditions

• R/R AML

Interventions

Type	Name	Description
BIOLOGICAL	CAR-ITNK Cells targeting CD70 and CLL1	Administer a single infusion of CAR-ITNK Cells targeting CD70 and CLL1 to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion

Timeline

• Start date: 2026-02-28
• Primary completion: 2028-02-28
• Completion: 2029-02-28
• First posted: 2026-01-13
• Last updated: 2026-01-13