NCT05008575

Anti-CD33 CAR NK Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

Phase I Study to Evaluate the Safety and Effectiveness of Anti-CD33 CAR NK Cell Therapy in Relapsed/Refractory Acute Myeloid Leukemia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

CAR technology has been used in T cell therapy and gets great success in treating hematological diseases. Following models of CAR T cells, CAR NK cell therapy has been one hot point. For myeloid malignancies, CD33 is widely expressed. Targeting CD33 surface antigens by CAR NK cells provides an off-the-shelf immune cell therapy.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD33 CAR NK cells	6×10\^8, 12×10\^8, 18×10\^8/KG Treatment follows a lymphodepletion
DRUG	Fludarabine	recommendation: 30mg/m2 (D-5\~D-3),determined by tumor burden at baseline.
DRUG	Cytoxan	recommendation: 300-500mg/m2 (D-5\~D-3),determined by tumor burden at baseline.

Timeline

• Start date: 2021-12-23
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2021-08-17
• Last updated: 2022-01-12

Locations

1 site across 1 country: China