NCT05215015

Study of Anti-CD33/CLL1 CAR-NK in Acute Myeloid Leukemia

Clinical Study of Conjugated Antibody Redirecting Natural Killer (CAR-NK) Cells Targeting CD33 and CLL1 in Patients With Acute Myeloid Leukemia

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Wuxi People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, nonrandomized, investigator-initiated clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of anti-CD33/CLL1 CAR-NK cell injection in patients with acute myeloid leukemia (AML), and to determine PK parameters, maximum tolerated dose (MTD), and phase II recommended dose (RP2D) for subjects receiving CAR-NK cell injection.

Detailed description

The treatment cycle in this study is 28 days. The administration of CAR-NK cells will be performed on day 1 and day 3 of each cycle. Subjects will be treated continuously until the criteria for termination of treatment are met. In this study, the dose escalation design is adopted. The first administration dose in the first cycle is 2.0×10\^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 3.0×10\^9 cells, and each administration dose in the second cycle and thereafter would be 3.0×10\^9 cells.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Anti-CD33/CLL1 CAR-NK Cells	The administration of CAR-NK cells will be performed on day 1 and day 3 of each cycle (28 days). The first administration dose in the first cycle is 2.0×10\^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 3.0×10\^9 cells, and each administration dose in the second cycle and thereafter would be 3.0×10\^9 cells.

Timeline

• Start date: 2020-11-30
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2022-01-31
• Last updated: 2022-01-31

Locations

1 site across 1 country: China