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CAR T-cell Therapy
CRISPR-Edited TIL Therapy for Gastrointestinal Cancer
Phase 1 & 2
Recruiting
Led By Emil Lou, MD, PhD
Research Sponsored by Intima Bioscience, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years or disease progression
Awards & highlights
Study Summary
This trial is testing whether genetically-engineered TIL cells, which have been edited with CRISPR to turn off the CISH checkpoint, are safe and effective at treating GI cancer.
Who is the study for?
Adults aged 18-70 with metastatic gastrointestinal cancers who've had at least one standard treatment can join. They need a measurable tumor for TIL generation, stable brain metastases if present, good organ function, no systemic steroids or recent investigational drugs, and must stay near the University of Minnesota post-treatment.Check my eligibility
What is being tested?
The trial is testing genetically-engineered Tumor Infiltrating Lymphocytes (TIL) where CISH gene is CRISPR-edited to boost immune response against cancer. It includes pre-treatment with Fludarabine and Cyclophosphamide followed by Aldesleukin after TIL infusion.See study design
What are the potential side effects?
Possible side effects include reactions to cell infusions like fever or chills, low blood counts leading to increased infection risk, nausea from chemotherapy drugs, and fatigue. Serious complications may involve organ inflammation due to immune overactivity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years or disease progression
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years or disease progression
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Preliminary efficacy of tumor reactive autologous lymphocytes with knockout of CISH gene in patients with refractory metastatic gastrointestinal epithelial cancers: changes in diameter
Safety of tumor reactive autologous lymphocytes with knockout of the CISH gene - Incidence of Adverse Events
Secondary outcome measures
Overall Survival (OS)
Progression-Free Survival (PFS)
Toxicity profiles resulting from treatment using these engineered tumor-infiltrating lymphocytes
Trial Design
2Treatment groups
Experimental Treatment
Group I: CISH CRISPR TIL / Phase II ArmExperimental Treatment4 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MTD of CISH inactivated TIL
Group II: CISH CRISPR TIL / Phase I ArmExperimental Treatment4 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine +escalating doses of CISH inactivated TIL + high-dose aldesleukin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Aldesleukin
FDA approved
Cyclophosphamide
FDA approved
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaOTHER
275 Previous Clinical Trials
14,790 Total Patients Enrolled
Intima Bioscience, Inc.Lead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
Emil Lou, MD, PhDPrincipal InvestigatorDivision of Hematology, Oncology and Transplantation, University of Minnesota
1 Previous Clinical Trials
70 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: CISH CRISPR TIL / Phase I Arm
- Group 2: CISH CRISPR TIL / Phase II Arm
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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