DELTA-2: ITIL-168 in Advanced Solid Tumors
Study Details
Study Description
Brief Summary
DELTA-2 is a phase 1 clinical trial to evaluate the safety, feasibility, and preliminary efficacy of ITIL-168 with pembrolizumab in participants with advanced cancer whose disease has progressed after standard therapy. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Cohort 1 Participants with cervical cancer whose disease has progressed during or after treatment with platinum-based chemotherapy. Participants with combined positive score ≥ 1 should also have disease that has progressed during or after treatment with CPI. |
Biological: ITIL-168
ITIL-168 is a cell therapy product derived from a participant's own TILs. A portion of tumor is resected to make a personalized ITIL-168 product. If appropriate, participants may receive bridging therapy after recovering from the tumor resection during ITIL-168 manufacturing. Once ITIL-168 has been made, the participant is treated with up to 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.
Drug: Pembrolizumab Participants will receive 1 dose of pembrolizumab following tumor resection prior to receiving ITIL-168, and additional doses for up to a year after ITIL-168 infusion.
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Experimental: Cohort 2 Participants with head and neck squamous-cell carcinoma (HNSCC) whose disease has progressed during or after platinum-based chemotherapy and previous CPI. |
Biological: ITIL-168
ITIL-168 is a cell therapy product derived from a participant's own TILs. A portion of tumor is resected to make a personalized ITIL-168 product. If appropriate, participants may receive bridging therapy after recovering from the tumor resection during ITIL-168 manufacturing. Once ITIL-168 has been made, the participant is treated with up to 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.
Drug: Pembrolizumab Participants will receive 1 dose of pembrolizumab following tumor resection prior to receiving ITIL-168, and additional doses for up to a year after ITIL-168 infusion.
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Experimental: Cohort 3 Participants with non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK) are required to have disease which has progressed on targeted therapy and platinum-based chemotherapy. |
Biological: ITIL-168
ITIL-168 is a cell therapy product derived from a participant's own TILs. A portion of tumor is resected to make a personalized ITIL-168 product. If appropriate, participants may receive bridging therapy after recovering from the tumor resection during ITIL-168 manufacturing. Once ITIL-168 has been made, the participant is treated with up to 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.
Drug: Pembrolizumab Participants will receive 1 dose of pembrolizumab following tumor resection prior to receiving ITIL-168, and additional doses for up to a year after ITIL-168 infusion.
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Outcome Measures
Primary Outcome Measures
- Frequency and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest [Up to 24 months]
Secondary Outcome Measures
- Objective response rate [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 investigator review.
- Duration of response [Up to 60 months]
For participants 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 [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 [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.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Histologically documented advanced (metastatic and/or unresectable) cervical cancer, HNSCC, or NSCLC.
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Cohort 1: Participants with cervical cancer whose disease progressed during or after at least 1 prior line of chemotherapy.
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Cohort 2: Participants with HNSCC whose disease progressed during or after chemotherapy that must have included a platinum agent and previous CPI.
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Cohort 3: Participants with NSCLC whose disease progressed during or after 1 prior line of platinum-based chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK) are required to have progressed on targeted therapy and platinum-based chemotherapy
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Medically suitable for surgical resection of tumor tissue
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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
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Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
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Adequate bone marrow and organ function
Key Exclusion Criteria:
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History of another primary malignancy within the previous 3 years
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Neuroendocrine carcinoma, nasopharyngeal carcinoma, squamous cell carcinoma of the lip, or histopathology with neuroendocrine differentiation
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Previously received an allogeneic stem cell transplant or organ allograft
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Previously received TIL or engineered cell therapy (eg, CAR T-cell)
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Significant cardiac disease
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Stroke or transient ischemic attack within 12 months of enrollment
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History of significant central nervous system (CNS) disorder
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Symptomatic and/or untreated CNS metastases
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History of significant autoimmune disease within 2 years prior to enrollment
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Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, IL-2, of CPI
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
2 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Instil Bio
Investigators
- Study Director: Instil Study Director, Instil Bio, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ITIL-168-102