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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 weeks
Treatment ~ Varies
Follow Up ~2 years or disease progression
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years or disease progression for reporting.

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
Cyclophosphamide
FDA approved
Aldesleukin
FDA approved

Find a Location

Who is running the clinical trial?

Intima Bioscience, Inc.Lead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
Masonic Cancer Center, University of MinnesotaOTHER
269 Previous Clinical Trials
14,576 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

Tumor-Infiltrating Lymphocytes (TIL) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04426669 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: CISH CRISPR TIL / Phase I Arm, CISH CRISPR TIL / Phase II Arm
Pancreatic Cancer Clinical Trial 2023: Tumor-Infiltrating Lymphocytes (TIL) Highlights & Side Effects. Trial Name: NCT04426669 — Phase 1 & 2
Tumor-Infiltrating Lymphocytes (TIL) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04426669 — Phase 1 & 2

Frequently Asked Questions

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

What benefits does Tumor-Infiltrating Lymphocytes (TIL) provide for patients?

"TIL therapy can be utilized to fight multiple sclerosis, leukemia, myelocytic and acute retinoblastoma."

Answered by AI

Who is the ideal population to recruit for this experiment?

"This medical trial is recruiting around 20 people who are within the ages of 18 and 70, as well as those suffering from gastrointestinal neoplasms."

Answered by AI

Can geriatrics partake in this research endeavor?

"As specified by the inclusion criteria, only patients between 18 and 70 years of age can join this trial. However, there are 376 trials available for minors and 2512 studies suitable for senior citizens."

Answered by AI

Are there available vacancies for participants in this experiment?

"According to the data hosted on clinicaltrials.gov, this medical trial is still recruiting participants since it was initially posted May 15th 2020 with an update on September 30th 2022."

Answered by AI

Could you provide an overview of the clinical trials that have tested Tumor-Infiltrating Lymphocytes (TIL) as a treatment?

"Presently, there are 913 clinical studies being conducted on Tumor-Infiltrating Lymphocytes (TIL), with 163 of those in the advanced Phase 3. The majority are found within Philadelphia, Pennsylvania, though a total of 28673 locations have trials running for this therapy."

Answered by AI

What is the current estimated enrollment of this medical trial?

"Affirmative. According to information hosted on clinicaltrials.gov, this trial is currently seeking participants and was first posted on May 15th 2020. It requires 20 patients from one medical centre for enrollment before September 30th 2022."

Answered by AI
Recent research and studies
~4 spots leftby Mar 2025