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

ConditionsSarcoma, SynovialSarcoma,Soft TissueMelanoma Stage IVTriple Negative Breast CancerMetastatic CancerNon Small Cell Lung CancerBladder Urothelial CarcinomaNeuroblastoma, MetastaticOvary Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHadassah Medical Organization

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Have histologically or cytologically confirmed diagnosis of neoplasia

Measurable (per RECIST v1.1 criteria) metastatic cancer or locally advanced refractory/recurrent malignancy not amenable to curative treatment. Lesions previously irradiated may be considered measurable only if growth has been documented since local treatment completion.

The tumor expresses ESO as assessed immunohistochemistry of resected tissue. To this end, archived tumor tissue suitable for analysis must be available or re-biopsy performed on study. Tissue staining must encompass more than 10% of tumor section.

Patients must have previously either (1) received at least first-line or second-line standard therapy for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease), intolerable or have recurred or (2) Recurred within 6 months of adjuvant systemic therapy known to be active also in the metastatic setting.

Disqualifiers

Women of child-bearing potential who are pregnant or breastfeeding.

Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).

Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses

Concurrent systemic steroid therapy, not including replacement therapy or treatment with prednisone up to 10mg daily or its equivalent. Or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention.

Trial design

Design model

Single group

Treatments tested in this trial

  • CYCLOPHOSPHAMIDE and FLUDARABIN

    Drug

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

  • Cyclophosphamide

    Drug

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

  • HBI 0201-ESO TCRT

    Biological/Vaccine

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

  • Aldesleukin

    Drug

    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.

Treatment groups

3 Participants
are divided into 1 treatment group
Group A: HBI 0201-ESO TCRT (Anti-NY-ESO-1 TCR-transduced peripheral blood lymphocytes)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Adverse events that occur following engineered T cell transfer

Time frame
5 years
2

objective tumor regression

change in index lesions' size

Time frame
5 years

Secondary outcomes

1

immune monitoring for transferred cells persistence

blood test for ESO-TCRT cells' presence

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hadassah Medical Organization

Lead sponsor

Source ClinicalTrials.gov
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