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CAR T-cell Therapy

ITIL-168 for Non-Small Cell Lung Cancer (DELTA-2 Trial)

Phase 1
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
Cohort 2: Participants with HNSCC whose disease progressed during or after chemotherapy that must have included a platinum agent and previous CPI.
Histologically documented advanced (metastatic and/or unresectable) cervical cancer, HNSCC, or NSCLC.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

DELTA-2 Trial Summary

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

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Cervical Cancer
  • Head and Neck Squamous Cell Carcinoma

DELTA-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

DELTA-2 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
Frequency and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
Secondary outcome measures
Duration of response
Objective response rate
Overall Survival
+1 more

DELTA-2 Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
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.
Group II: Cohort 2Experimental Treatment1 Intervention
Participants with head and neck squamous-cell carcinoma (HNSCC) whose disease has progressed during or after platinum-based chemotherapy and previous CPI.
Group III: Cohort 1Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Instil BioLead Sponsor
2 Previous Clinical Trials
80 Total Patients Enrolled
Instil Study DirectorStudy DirectorInstil Bio, Inc.
2 Previous Clinical Trials
80 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 clearance to ITIL-168?

"Given the lack of robust evidence for safety and efficacy, ITIL-168 was assigned a rating of 1 on our team's numerical scale."

Answered by AI

Are any additional participants being enrolled into this research project?

"According to clinicaltrials.gov, recruitment for this medical trial closed after the study was posted on August 15th 2022 and updated last November 1st. Nonetheless, there are currently 2462 other studies that require participants."

Answered by AI
~0 spots leftby Mar 2025