NCT05266950

Safety and Efficacy Study of CI-135 CAR-T Cells in Subjects with Relapsed or Refractory Acute Myeloid Leukemia

First-in-Human (FIH), Open-Label, Non-Randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Efficacy of CI-135 CAR-T Cells in Subjects with Relapsed or Refractory Acute Myeloid Leukemia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Beijing Boren Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and efficacy of CI-135 CAR-T cells in subjects with relapsed or refractory Acute Lymphoblastic Leukemia. This study is a dose-escalation study that includes 2 dose levels, and a total of 4-7 subjects will be enrolled. CI-135 CAR-T cells will be manufactured using PBMC collected from the subjects, and will be infused intravenously into subjects after lymphodepletion.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CI-135 CAR-T cells (0.5 x 10^6 CAR-T+ cells/kg，1.0 x 10^6 CAR-T+ cells/kg)	Recommended lymphodepletion regimen: cyclophosphamide (250 mg/m2/d, ×3d) and fludarabine (30 mg/m2/d, ×3d). If the patient has a hematological toxicity of grade 3 or higher, the alternative regimen is: cyclophosphamide (125mg/m2/d, ×3d) and fludarabine (15 mg/m2/d, ×3d). During lymphodepletion, physicians can give anti-myeloid drugs such as demethoxydaunorubicin or daunorubicin as appropriate.

Timeline

• Start date: 2021-12-13
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2022-03-04
• Last updated: 2024-11-14

Locations

1 site across 1 country: China