ITIL-168 in Advanced Melanoma (DELTA-1)
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ClinicalTrials.gov Identifier: NCT05050006 |
Recruitment Status :
Terminated
(Business Decision)
First Posted : September 20, 2021
Last Update Posted : April 16, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Cutaneous Melanoma | Biological: ITIL-168 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 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 |
Actual Primary Completion Date : | February 27, 2023 |
Actual Study Completion Date : | February 27, 2023 |
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.
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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. |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 ]
- 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.
- Best Overall Response [ Time Frame: Up to 60 months ]
- Time to Response [ Time Frame: Up to 60 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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
Study Director: | Instil Study Director | Instil Bio, Inc. |
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: | April 16, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Skin Neoplasms Neoplasms by Site Skin Diseases |