NCT04923919

Clinical Study of Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Myeloid Leukemia

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Academic / Other
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Researchers plan to enroll a total of 100 patients with relapsed, refractory acute myeloid leukemia (AML) to receive a single dose of autologous CAR T cells.The safety of CAR T therapy was evaluated by observing adverse events after cell therapy;The efficacy of CAR-T therapy was evaluated against the outcome of patients' own past standard treatment regimens or historical data.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the pharmacokinetics (PK) of CAR T cells.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Anti-CLL1 CART cells	In this study, patients with acute myeloid leukemia were treated with autologous anti-CLL1 CAR T cells by a single, intravenous infusion.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the efficacy of CAR T cells.

Timeline

• Start date: 2021-09-14
• Primary completion: 2024-12-05
• Completion: 2024-12-05
• First posted: 2021-06-11
• Last updated: 2023-07-13

Locations

1 site across 1 country: China