Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Gregory Daniels, MD, PhD
Photo of Gregory Daniels
Gregory Daniels

Description

Summary

DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).

Official Title

A Phase 2, Open-label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects With Advanced Melanoma (DELTA-1)

Keywords

Advanced Cutaneous Melanoma ITIL-168 Cell Therapy melanoma Autologous cell therapy Cellular Immunotherapy TIL Autologous Adoptive Cell Transfer Immuno-oncology IL-2 Autologous Adoptive Cell Therapy Tumor Infiltrating Lymphocytes T-cell therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed advanced (unresectable or metastatic) cutaneous melanoma.
  • Cohort 1: Disease that is relapsed after or refractory to at least 1 prior line of systemic therapy that must include a PD-1 inhibitor and, if positive for proto-oncogene BRAF V600 activating mutation, targeted therapy.
  • Cohort 2: Disease that is persistent after discontinuing PD-1 due to toxicity. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
  • Cohort 3: Disease that is stable (SD) after at least 4 doses of a PD-1 inhibitor. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
  • Medically suitable for surgical resection of tumor tissue
  • Following tumor resection for TIL harvest, will have, at minimum, 1 remaining measurable lesion as identified by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow and organ function

You CAN'T join if...

  • History of another primary malignancy within the previous 3 years
  • Melanoma of uveal, acral, or mucosal origin
  • Previously received an allogeneic stem cell transplant or organ allograft
  • Previously received TIL or engineered cell therapy ( eg, CAR T-cell)
  • Significant cardiac disease
  • Stroke or transient ischemic attack within 12 months of enrollment
  • History of significant central nervous system (CNS) disorder
  • Symptomatic and/or untreated CNS metastases
  • History of significant autoimmune disease within 2 years prior to enrollment
  • Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, or IL-2.

Locations

  • University of California San Diego, Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UCLA Health-Westwood Cancer Care accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Instil Bio
ID
NCT05050006
Phase
Phase 2
Study Type
Interventional
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