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ITIL-168 in Advanced Melanoma (DELTA-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05050006
Recruitment Status : Active, not recruiting
First Posted : September 20, 2021
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
Instil Bio

Brief 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).

Condition or disease Intervention/treatment Phase
Advanced Cutaneous Melanoma Biological: ITIL-168 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All enrolled participants are assigned to be treated with a single dose of ITIL-168
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 7, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : August 2028

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Cohort 1
Patients who relapsed after or were refractory to at least 1 prior line of systemic therapy including a PD-1 inhibitor.
Biological: ITIL-168
ITIL-168 is a cell therapy product derived from a patient's own TILs. A tumor sample is removed from each patient to make a personalized ITIL-168 product. Once ITIL-168 has been made, the patient is treated with 5 days of lymphodepleting chemotherapy including cyclophosphamide and fludarabine, followed by a single infusion of ITIL-168, and up to 8 doses of IL-2.

Experimental: Cohort 2
Patients who were intolerant to a PD-1 inhibitor and have persistent disease after stopping PD-1 therapy.
Biological: ITIL-168
ITIL-168 is a cell therapy product derived from a patient's own TILs. A tumor sample is removed from each patient to make a personalized ITIL-168 product. Once ITIL-168 has been made, the patient is treated with 5 days of lymphodepleting chemotherapy including cyclophosphamide and fludarabine, followed by a single infusion of ITIL-168, and up to 8 doses of IL-2.

Experimental: Cohort 3
Patients who had a best response of stable disease despite being treated with at least 4 doses of a PD-1 inhibitor in the previous line of therapy.
Biological: ITIL-168
ITIL-168 is a cell therapy product derived from a patient's own TILs. A tumor sample is removed from each patient to make a personalized ITIL-168 product. Once ITIL-168 has been made, the patient is treated with 5 days of lymphodepleting chemotherapy including cyclophosphamide and fludarabine, followed by a single infusion of ITIL-168, and up to 8 doses of IL-2.




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: Up to 60 months ]
    Objective response rate (ORR), defined as the incidence of a complete response (CR) or a partial response (PR) per a modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria, as assessed by central review.


Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: Up to 60 months ]
    For subjects who experience an objective response, duration of response (DOR) is defined as the time from their first objective response to disease progression or death.

  2. Progression-free Survival [ Time Frame: Up to 60 months ]
    Progression-free survival (PFS) is defined as the time from the ITIL-168 infusion date to the date of disease progression or death from any cause.

  3. Overall Survival [ Time Frame: Up to 60 months ]
    Overall survival (OS) is defined as the time from the ITIL-168 infusion date to the date of death from any cause.

  4. ORR as determined by investigators [ Time Frame: Up to 60 months ]
    ORR as determined by investigators is defined as the incidence of a CR or a PR per a modified RECIST v1.1, as determined by study investigators.

  5. Frequency, duration, and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest [ Time Frame: Up to 60 months ]
  6. Disease Control Rate [ Time Frame: Up to 60 months ]
    Disease control rate (DCR), defined as the incidence of CR, PR, or stable disease (SD) per a modified RECIST v1.1 criteria, as determined by central review.

  7. Best Overall Response [ Time Frame: Up to 60 months ]
  8. Time to Response [ Time Frame: Up to 60 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05050006


Locations
Show Show 22 study locations
Sponsors and Collaborators
Instil Bio
Investigators
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Study Director: Instil Study Director Instil Bio, Inc.
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Responsible Party: Instil Bio
ClinicalTrials.gov Identifier: NCT05050006    
Other Study ID Numbers: ITIL-168-101
2020-003862-37 ( EudraCT Number )
First Posted: September 20, 2021    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instil Bio:
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
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas