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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

December 30, 2027

Study Completion Date

December 30, 2027

Conditions
Sarcoma, SynovialSarcoma,Soft TissueMelanoma Stage IVTriple Negative Breast CancerMetastatic CancerNon Small Cell Lung CancerBladder Urothelial CarcinomaNeuroblastoma, MetastaticOvary Cancer
Interventions
DRUG

CYCLOPHOSPHAMIDE and FLUDARABIN

1\. CYCLOPHOSPHAMIDE 250 mg/msq, Day -5,-4,-3 with FLUDARABIN 25 mg/msq, Day -5,-4,-3

DRUG

Cyclophosphamide

CYCLOPHOSPHAMIDE 250 mg/msq, Day -6, -5,-4,-3

BIOLOGICAL

HBI 0201-ESO TCRT

HBI 0201-ESO TCRT will be infused on Day 0, after lymphodepletion. Three dose levels will be evaluated: 1x10E9, 5x10E9 and 1x10E10.

DRUG

Aldesleukin

Continuous infusion of aldesleukin 18x10E6 IU/24h will be given 24 hours post HBI 0201-ESO TCRT infusion, for four days or until a dose limiting toxicity will occur that mimics cytokine release syndrome (CRS) including blood pressure drop, oliguria or confusion- all of them or any one alone.

Trial Locations (1)

9112001

RECRUITING

Hadassah Medical Organization, Jerusalem

All Listed Sponsors
lead

Hadassah Medical Organization

OTHER