NCT05445765

Anti-CD33 CAR-T Cells for the Treatment of Relapsed/Refractory CD33+ Acute Myeloid Leukemia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: iCell Gene Therapeutics · Industry
• Sex: All
• Age: 2 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD33 CAR-T cells in patients with relapsed and/or refractory, high risk hematologic malignancies.

Detailed description

AML is a rapidly progressing blood cancer and treated by high-dose multi-agent chemotherapy potentially followed by hematopoietic stem cell transplantation. Despite such intensive therapies, which are often associated with considerable toxicities and even death, about 60-70% of AML patients still relapse. Furthermore, the five-year survival rate from AML remains at a dismal 27%. AML is composed mostly of CD33+ leukemic blast cells. Therefore, CD33 is a potential good target by CAR T cells.

Conditions

• Relapsed and/or Refractory Acute Myeloid Leukemia
• High Risk Hematologic Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD33 CAR T cells	Anti-CD33 CAR T cells are used to treat patients. Patient will be administered either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2022-07-06
• Last updated: 2022-07-06

Locations

1 site across 1 country: China