NCT05296564

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

A Phase I/II Dose Escalation, Safety and Efficacy Study of Anti-NY-ESO-1 T Cell Receptor (TCR)-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a two-part, non-randomized, open label, single-site Phase I/II study. The first Part A is a dose ranging maximum tolerated dose (MTD) study and Part B is an extension phase to evaluate safety at the selected safe dose. A Data Safety Monitoring Board (DSMB) will determine the safe dose for testing in the expansion phase (Part B). Part A will be according to a 3+3 dose escalation design. A total of up to 20 patients will participate in this Part. Part B will be an expansion phase. The objective will be to determine if the treatment regimen is associated with a clinical response rate that can rule out 5% (p0=0.05) in favor of a modest 20% Partial Response (PR) + Complete Response (CR) rate (p1=0.20). A total of up to 43 patients may be enrolled in Part B (41 +2, allowing for up to 2 non-evaluable patients).

Conditions

• Sarcoma, Synovial
• Sarcoma,Soft Tissue
• Melanoma Stage IV
• Triple Negative Breast Cancer
• Metastatic Cancer
• Non Small Cell Lung Cancer
• Bladder Urothelial Carcinoma
• Neuroblastoma, Metastatic
• Ovary Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-01
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2022-03-25
• Last updated: 2025-10-02

Locations

1 site across 1 country: Israel