NCT06585345

Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With Relapsed/Refractory Acute Leukemia

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The General Hospital of Western Theater Command · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Acute leukemia is a malignant clonal disease of hematopoietic stem cells. At present, the treatment for acute leukemia is relatively limited, and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation. The prognosis of recurrent and refractory acute leukemia is poor, and there is a lack of effective treatment plan. CD7 is a specific target on the surface of T cells, and CD7 CAR-T is expected to provide a new therapeutic path for patients with relapsed refractory acute leukemia.This is an open, single-arm, single-center, prospective clinical study. The main objective of the clinical study is to evaluate the clinical safety and tolerability of CD7 CAR-T in the treatment of acute leukemia.

Detailed description

CD7 expression was determined by flow cytometry. After the target was determined, the subjects received the target dose of CD7 CAR-T from 1×105 to 1×108 /kg. Each subject will start with a low dose of 1×105/kg and if there are no significant side effects will be increased to the next dose until the maximum tolerated dose is reached. A variety of adverse events (including neurological events, hematological events, infections, and secondary tumors) will be collected from the time of infusion of CAR T cells to 24 months after infusion. To understand the complete response rate (CR) and partial response rate (PR) at 3 months; Recurrence rate, progression-free survival (PFS) and overall survival (OS) after 1 to 5 years of CD7 CAR-T reinfusion; The amount and duration of CD7 CAR-T in vivo.

Conditions

• Acute-Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CD7 CAR-T cell	Split intravenous infusion of CD7 CAR-T cells \[dose escalating infusion of (1-100)x10\^6 CD7 CAR-T cells/kg\]

Timeline

• Start date: 2024-02-18
• Primary completion: 2027-12-31
• Completion: 2030-11-01
• First posted: 2024-09-05
• Last updated: 2024-09-05

Locations

1 site across 1 country: China