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787 DELTA-1: a global, multicenter, phase 2 study of ITIL-168, an unrestricted autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in adult patients with advanced cutaneous melanoma
  1. Brian Gastman1,
  2. Amod Sarnaik2,
  3. Donald Lawrence3,
  4. Anthony Olszanski4,
  5. Bartosz Chmielowski5,
  6. Jose Lutzky6,
  7. Marcus Butler7,
  8. Omid Hamid8,
  9. Pippa Corrie9,
  10. Evidio Domingo-Musibay10,
  11. Sajeve Thomas11,
  12. Fiona Thistlethwaite12,
  13. Gregory Daniels13,
  14. Thomas Evans14,
  15. Andrew Furness15,
  16. Geoffrey Gibney16,
  17. Mark Harries17,
  18. Theresa Medina18,
  19. Daniel Olson19,
  20. Lalit Pallan20,
  21. Eric Whitman21,
  22. Melissa Wilson22,
  23. Jeff Aycock23,
  24. Robert Hawkins23,
  25. Yizhou Jiang23,
  26. Audrey Kennedy23,
  27. Paul Robbins23,
  28. Zachary Roberts23 and
  29. John Le Gall23
  1. 1Cleveland Clinic, Cleveland, OH, USA
  2. 2Moffitt Cancer Center, Tampa, FL, USA
  3. 3Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
  4. 4Fox Chase Cancer Center, Philadelphia, PA, USA
  5. 5University of California Los Angeles, Los Angeles, CA, USA
  6. 6University of Miami, Miami, FL, USA
  7. 7Princess Margaret Cancer Centre, Ontario, Canada
  8. 8The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate, Los Angeles, CA, USA
  9. 9Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
  10. 10University of Minnesota, Masonic Cancer Center, Minneapolis, MN, USA
  11. 11Orlando Health Cancer Institute, Orlando, FL, USA
  12. 12The Christie NHS Foundation Trust and University of Manchester, Manchester, UK
  13. 13University of California San Diego, Moores Cancer Center, La Jolla, CA, USA
  14. 14University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK
  15. 15The Royal Marsden NHS Foundation Trust, London, UK
  16. 16MedStar Georgetown University Hospital, Washington, DC, USA
  17. 17Guy’s and St. Thomas’ NHS Foundation Trust, London, UK
  18. 18University of Colorado, Denver, CO, USA
  19. 19University of Chicago, Chicago, IL, USA
  20. 20University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
  21. 21Atlantic Health System, Morristown, NJ, USA
  22. 22St. Luke’s University Health Network, Easton, PA, USA
  23. 23Instil Bio, Inc., Dallas, TX, USA


Background Investigational autologous TIL cell therapies have shown promise in patients with advanced cutaneous melanoma and persistent disease after checkpoint inhibitor therapy, a population with a high unmet medical need.1,2 Made from autologous digested and cryopreserved tumor, ITIL-168 is a TIL cell therapy manufactured to offer an unrestricted T-cell receptor repertoire. DELTA-1 (NCT05050006) is a global, multicenter, phase 2 study evaluating efficacy and safety of ITIL-168 in patients with cutaneous melanoma relapsed or refractory to a PD-1i, patients intolerant to a PD-1i, and patients with stable disease on a PD-1i.

Methods Adult patients with histologically confirmed advanced cutaneous melanoma and ECOG performance status 0-1 will be enrolled in 1 of 3 cohorts. Cohort 1 (n≈80) will include patients who relapsed after or were refractory to ≥1 prior line of systemic therapy, including a PD-1i and, if BRAF-mutated, a BRAFi ± MEKi. Cohorts 2 and 3 (n≈25 each) will include patients intolerant to PD-1i and those with stable disease after ≥4 doses of PD-1i, respectively. After tumor harvest, patients must have ≥1 measurable lesion per RECIST 1.1. Noncutaneous melanoma, certain prior therapies, and patients with symptomatic and/or untreated central nervous system metastases are ineligible. Patients will receive 5 days of lymphodepleting chemotherapy (cyclophosphamide ×2 days overlapping with fludarabine ×5 days) followed by a single ITIL-168 infusion and supportive IL-2. The primary endpoint is objective response rate (ORR) per central review. Secondary endpoints include duration of response, progression-free survival, overall survival, disease control rate, TIL persistence, and safety. Hypothesis testing of ORR will be performed for cohort 1. The primary analysis will occur ≥6 months after the first posttreatment disease assessment of patients in the cohort 1 modified intent-to-treat population. Enrollment has expanded into Canada and Europe.

Acknowledgements Medical writing support was provided by Christopher Waldapfel, PharmD, of Instil Bio, Inc. and Phylicia Aaron, PhD, of Nexus Global Group Science, with funding from Instil Bio, Inc.


  1. Schadendorf D, van Akkoi ACJ, Berking C, et al. Melanoma. Lancet. 2018;392(10151):971-984.

  2. Borch TH, Anderson R, Ellebaek E, et al. Future role for adoptive T-cell therapy in checkpoint inhibitor-resistant metastatic melanoma. J Immunother Cancer. 2020;8(2):e000668.

Ethics Approval All patients will provide written informed consent. The study will be approved by the Institutional Review Board/Independent Ethics Committee at each site and conducted in accordance with the Good Clinical Practice Guidelines of the International Council for Harmonisation.

Consent N/A; the abstract does not contain sensitive or identifiable patient information.

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