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 HBI 0201-ESO TCRT (anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes) Given by Infusion to Patients with NY-ESO-1 -Expressing Metastatic Cancers

Trial Details

NCT ID
NCT05296564
Phase
PHASE1 / PHASE2
Sponsor
Hadassah Medical Organization
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • CYCLOPHOSPHAMIDE and FLUDARABIN
  • Cyclophosphamide
  • HBI 0201-ESO TCRT
  • Aldesleukin
Locations (sample)
  • Jerusalem, Israel|31.76904,35.21633

Key Eligibility Criteria

  • 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. Les…
  • The tumor expresses ESO as assessed immunohistochemistry of resected tissue. To this end, archived tumor tissue suitable for analysis must be avail…
  • Patients must have previously either (1) received at least first-line or second-line standard therapy for metastatic disease, if known to be effect…

For full eligibility, visit ClinicalTrials.gov.

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