drugset / Trial / NCT05266950

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

NCT05266950 ↗

Phase 1 Withdrawn Beijing Boren Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-12-13
Primary completion
2023-12-12
Completion
2023-12-12

Outcome

Outcome not reported

Stopped: “Difficulty in joining the group”

Drugs

EvaluationDrugModalityDoseRoute
Subject CI-135 Cell therapy 0.5 cells/kg Intravenous
Subject CI-135 Cell therapy 1 cells/kg Intravenous