RecruitingPhase 1Phase 2NCT05296564

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

Sponsor

Hadassah Medical Organization

Enrollment

3 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Sarcoma, Synovial Sarcoma,Soft Tissue Melanoma Stage IV

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study uses a type of gene therapy called TCR-engineered T-cells — immune cells that have been genetically modified in the lab to target a protein called NY-ESO-1 found on some cancer cells — to treat people with advanced cancers that express this protein. **You may be eligible if...** - You are 18 or older - You have an advanced or metastatic cancer confirmed by biopsy - Your tumor has been tested and found to express the NY-ESO-1 protein (in more than 10% of tumor cells) - Your cancer cannot be cured with available treatments and has progressed after at least one standard treatment - You are in reasonably good general health **You may NOT be eligible if...** - Your tumor does not express the NY-ESO-1 protein - You have not received any prior standard treatment - You have active autoimmune disease or require immune-suppressing medications - You are pregnant or breastfeeding - You have active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCYCLOPHOSPHAMIDE and FLUDARABIN

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

DRUGCyclophosphamide

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

BIOLOGICALHBI 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.

DRUGAldesleukin

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.