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CAR T-cell Therapy

Genetically Modified T Cells for Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HLA-A*02:01 or HLA-A*02:06 positive

Age ≥16 years on consent

Must not have

Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

History of organ transplant that requires use of immunosuppressives

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trialtests safety of genetically modified T cells to attack and destroy cancer in ppl with advanced solid tumors (ovarian, synovial sarcoma, esophageal, lung, bladder, liver, and malignant melanoma). Subjects' T cells are modified and given back to them through an IV infusion.

Who is the study for?

This trial is for adults with advanced solid tumors expressing NY-ESO-1, including lung, ovarian, and liver cancers. Participants must have a specific immune system marker (HLA-A*02:01 or HLA-A*02:06), an ECOG status of 0 or 1 indicating they are fully active or restricted in physically strenuous activity but ambulatory, measurable disease progression post-treatment, and adequate organ function. Pregnant women and those with autoimmune diseases, uncontrolled infections, recent immunosuppressants use (except certain steroids), HIV/HTLV/syphilis/hepatitis B/C infections are excluded.

What is being tested?

The study tests TBI-1301 therapy where patients' own T cells are genetically modified to target cancer cells expressing the NY-ESO-1 antigen. The safety of these engineered T cells will be evaluated along with their effect on tumor size using RECIST v1.1 criteria after pre-treatment with cyclophosphamide and fludarabine.

What are the potential side effects?

Potential side effects include reactions related to immune response such as inflammation in various organs due to the targeted attack by modified T cells against cancerous tissues; infusion-related reactions from receiving the cells back into the body; fatigue; blood disorders; increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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I am positive for HLA-A*02:01 or HLA-A*02:06.

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I am 16 years old or older.

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My tumor tests positive for NY-ESO-1.

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My cancer has spread or returned and cannot be surgically removed.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had Crohn's disease or ulcerative colitis.

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I have had an organ transplant and take drugs to suppress my immune system.

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I don't have any severe illnesses that could affect my participation in the trial.

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I do not have cancer spread to my brain or spinal cord.

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I have a history of tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort C (double infusion)Experimental Treatment3 Interventions

Cyclophosphamide will be given intravenously (by vein) at a fixed dose of 750mg/m\^2/d for 2 days. Fludarabine will be given intravenously at a fixed dose of 30mg/m\^2/d for 2 days. TBI-1301 cells will be infused on Day 0 and Day 14 at a dose of 5x10\^9 cells.

Group II: Cohort B (retreatment)Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

TBI-1301

2017

Completed Phase 2