drugset / Trial / NCT06911710

The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors

NCT06911710

NaSingle-groupOpen-labelTreatment

Summary

This study is an open, single-arm, prospective, Phase I/II clinical study using "3+3" dose escalation and dose expansion to investigate the safety, maximum tolerated dose, in vivo pharmacokinetic profile, and preliminary efficacy of CAR-T cell injections for the treatment of relapsed/refractory malignant hematological neoplasms in subjects.

Timeline

Start
2024-11-09
Primary completion
2026-02-28
Completion
2027-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject CAR19 Cell therapy 1e+06 cells/kg Other
Subject CAR19 Cell therapy 1.5e+06 cells/kg Other
Subject CAR19 Cell therapy 2e+06 cells/kg Other
Subject CAR19 Cell therapy 2.5e+06 cells/kg Other
Subject CAR19 Cell therapy 3e+06 cells/kg Other
Subject CAR2019 Cell therapy 1e+06 cells/kg Other
Subject CAR2019 Cell therapy 1.5e+06 cells/kg Other
Subject CAR2019 Cell therapy 2e+06 cells/kg Other
Subject CAR2019 Cell therapy 2.5e+06 cells/kg Other
Subject CAR2019 Cell therapy 3e+06 cells/kg Other
Subject CAR2219 Cell therapy 1e+06 cells/kg Other
Subject CAR2219 Cell therapy 1.5e+06 cells/kg Other
Subject CAR2219 Cell therapy 2e+06 cells/kg Other
Subject CAR2219 Cell therapy 2.5e+06 cells/kg Other
Subject CAR2219 Cell therapy 3e+06 cells/kg Other