← Back to Search

CAR T-cell Therapy

Cohort B (retreatment) 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am positive for HLA-A*02:01 or HLA-A*02:06.
Select...
I am 16 years old or older.
Select...
My tumor tests positive for NY-ESO-1.
Select...
My cancer has spread or returned and cannot be surgically removed.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended phase 2 (RP2D) dose o TBI-1301 when administered following cyclophosphamide and fludarabine pre-treatment
Safety profile (i.e. adverse events, presence/absence of RCR, analysis of clonality and PK of TBI-1301) assessed by CTCAE v.4.0 and laboratory testings.
Secondary outcome measures
Evidence of efficacy (i.e. anti-tumor effect) of TBI-1301 measured using RECIST v1.1

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
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 at a dose of 5x10^9 cells. *Patients will only enter into this cohort if they have already been enrolled in another cohort prior
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
TBI-1301
2017
Completed Phase 2
~10
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,497 Total Patients Enrolled
Takara Bio Inc.Industry Sponsor
13 Previous Clinical Trials
246 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Princess Margaret Cancer Centre
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
2016. "Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02869217.
All > Tb > Synovial Sarcoma
~1 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top