drugset / Trial / NCT05296564

Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers

NCT05296564

Phase 1/2 Recruiting 3 enrolled Hadassah Medical Organization
NaSingle-groupOpen-labelTreatment

Summary

A Phase I/II Dose Escalation, Safety and Efficacy Study of HBI 0201-ESO TCRT (anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes) Given by Infusion to Patients with NY-ESO-1 -Expressing Metastatic Cancers

Timeline

Start
2022-04-01
Primary completion
2027-12-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject HBI 0201-ESO TCRT Cell therapy 1e+09 cells Other
Subject HBI 0201-ESO TCRT Cell therapy 5e+09 cells Other
Subject HBI 0201-ESO TCRT Cell therapy 1e+10 cells Other
Background Cyclophosphamide Other / unclassified 250 mg/m2
Background Fludarabin Unknown 25 mg/m2
Background aldesleukin Protein / enzyme biologic 1.8e+07 iu Other