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CAR T-cell Therapy

ITIL-168 for Melanoma (DELTA-1 Trial)

Phase 2
Waitlist Available
Research Sponsored by Instil Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate bone marrow and organ function.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

DELTA-1 Trial Summary

This trial is testing a new treatment for melanoma that uses the patient's own immune cells.

Eligible Conditions
  • Melanoma

DELTA-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your bone marrow and organs are working properly.
Select...
You have a disease that did not improve after stopping PD-1 treatment because of side effects. If you have a specific BRAF gene mutation, you must have tried targeted therapy and your disease has still worsened.

DELTA-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate
Secondary outcome measures
Best Overall Response
Disease Control Rate
Duration of Response
+5 more

DELTA-1 Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
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.
Group II: Cohort 2Experimental Treatment1 Intervention
Patients who were intolerant to a PD-1 inhibitor and have persistent disease after stopping PD-1 therapy.
Group III: Cohort 1Experimental Treatment1 Intervention
Patients who relapsed after or were refractory to at least 1 prior line of systemic therapy including a PD-1 inhibitor.

Find a Location

Who is running the clinical trial?

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its blessing to ITIL-168?

"ITIL-168's safety was rated a 2 by our Power company team. Phase 2 trials have shown some evidence of safety, but there is no data currently backing the efficacy of ITIL-168."

Answered by AI

Are we still looking for individuals to participate in this research?

"From what is publicly available on clinicaltrials.gov, it seems that this particular medical trial has stopped enrolling new patients. The first posting was on October 7th 2021 with the most recent update being November 1st 2022. However, there are 783 other trials which are still recruiting patients."

Answered by AI

Could you please tell me how many hospitals are participating in this research?

"Trial sites for this research include University of Colorado - Anschutz Cancer Pavilion in Aurora, Colorado, UCLA Health-Westwood Cancer Care in Los Angeles, California, and Georgetown University Medical Center in Washington D.C., amongst 22 other locations."

Answered by AI
~8 spots leftby Mar 2025