ITIL-168 for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Malignant Neoplasms+7 More
ITIL-168 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions

  • Non-small Cell Lung Cancer
  • Cervical Cancers
  • Malignant Neoplasms

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 60 months

Up to 24 months
Frequency and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
Up to 60 months
Duration of response
Objective response rate
Overall Survival
Progression-free Survival

Trial Safety

Trial Design

3 Treatment Groups

Cohort 1
1 of 3
Cohort 2
1 of 3
Cohort 3
1 of 3
Experimental Treatment

27 Total Participants · 3 Treatment Groups

Primary Treatment: ITIL-168 · No Placebo Group · Phase 1

Cohort 1
Biological
Experimental Group · 1 Intervention: ITIL-168 · Intervention Types: Biological
Cohort 2
Biological
Experimental Group · 1 Intervention: ITIL-168 · Intervention Types: Biological
Cohort 3
Biological
Experimental Group · 1 Intervention: ITIL-168 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 60 months
Closest Location: Massachusetts General Hospital · Boston, MA
Photo of Massachusetts General Hospital 1Photo of Massachusetts General Hospital 2Photo of Massachusetts General Hospital 3
1993First Recorded Clinical Trial
0 TrialsResearching Malignant Neoplasms
2427 CompletedClinical Trials

Who is running the clinical trial?

Instil BioLead Sponsor
2 Previous Clinical Trials
181 Total Patients Enrolled
Instil Study DirectorStudy DirectorInstil Bio, Inc
2 Previous Clinical Trials
181 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Cohort 1: Participants with cervical cancer whose disease progressed during or after at least 1 prior line of chemotherapy.
The patient must have had a tumor resection for TIL harvest
You have a performance status of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.