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NY-ESO-1 Expressing Solid Tumors in HLA-A2 Positive PatientsPhase 1NCT02869217

Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors

A Phase 1 study testing Cyclophosphamide, TBI-1301 and Fludarabine in people with NY-ESO-1 Expressing Solid Tumors in HLA-A2 Positive Patients and Synovial Sarcoma, run by University Health Network, Toronto at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The target populations for this phase I study with TBI-1301 are patients with advanced solid tumors. Patients' tumors will be required to express NY-ESO-1, which include but is not limited to ovarian cancer, synovial sarcoma, esophageal cancer, lung cancer, bladder cancer, liver cancer, and malignant melanoma. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
Cyclophosphamide, TBI-1301 and Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteCanada
Study dates
Sep 2016to Nov 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed metastatic or recurrent unresectable solid tumor.
  • HLA-A*02:01 or HLA-A*02:06 positive.
  • Tumor NY-ESO-1 expression by immunohistochemistry.
  • No anti-cancer chemotherapy, radiation therapy or immunotherapy within 2 weeks or 5 half-lives of PBMC harvest.
  • The treating investigator should consider the patient to have disease that is incurable and that the patient would be a reasonable candidate for future treatment with TBI-1301.
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >10 mm with CT scan, MRI, or calipers by clinical exam. Patients must have radiographic evidence of disease progression following the most recent line of treatment. Areas of previous radiation may not serve as measurable disease unless there is evidence of progression post radiation.
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  • ECOG Performance Status 0 or 1.
  • Age ≥16 years on consent.
  • Life expectancy greater than 4 months.
  • The following laboratory requirements must be met (within 14 days prior to phlebotomy for generation of TBI-1301):
  • Absolute neutrophil count (ANC) ≥1.5 x10^9/L (1500/μL) without G-CSF support
  • WBC ≥ 2.5x10^9/L (2,500/μl)
  • Lymphocytes ≥ 0.5x10^9/L (500/μl)
  • Hemoglobin ≥ 80 g/L
  • Platelets ≥ 75x10^9/L (75,000/μl)
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤2.5X if Gilbert's disease)
  • AST(SGOT), ALT(SGPT) < 3.0 x ULN (< 5 x ULN with known liver metastases)
  • Creatinine ≥ 60 ml/min (calculated by Cockcroft and Gault)
  • Adequate renal function
  • Consent must be appropriately obtained in accordance with applicable local and regulatory requirements.

Who cannot join

  • Uncontrolled intercurrent illnesses or medical conditions that may interfere with trial participation such as ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, severe active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirement or compromise the ability of the subject to give written informed consent.
  • Patients who are receiving any other investigational agents.
  • Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with vitiligo, Grave's disease, Hashimoto's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
  • Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
  • No evidence of active uncontrolled infection (patients on antibiotics are eligible).
  • History of primary immunodeficiency.
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  • History of organ transplant that requires use of immunosuppressives.
  • Known allergy or reaction to a known component of TBI-1301.
  • Untreated central nervous system metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids. If treated lesions are shown to be stable for 1 month the subject may be eligible.
  • Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured.
  • Current or prior use of immunosuppressive medication within 14 days before phlebotomy, with the exceptions of intranasal, topical, and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent. Oral steroid use as premedication to prevent allergic reactions to radiologic contrast is allowed.
  • Any condition that, in the opinion of the investigator, would interfere with the evaluation of TBI-1301 or interpretation of subject safety or study results.
  • Known history of tuberculosis.
  • HIV positive.
  • Active HTLV or syphilis infection.
  • Active hepatitis B infection (hepatitis B surface antigen or HBV DNA positive).
  • Active hepatitis C infection (if hepatitis C antibody positive, HCV RNA positive).
  • Has no known active central nervous system metastases and/or carcinomatous meningitis.
  • Ongoing prior toxicities related to previous anti-cancer treatments (surgery, radiotherapy or adjuvant chemo-radiation) must be recovered to < grade 1 or baseline
  • Pregnant women are excluded.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Phase Ib Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors

The target populations for this phase I study with TBI-1301 are patients with advanced solid tumors. Patients' tumors will be required to express NY-ESO-1, which include but is not limited to ovarian cancer, synovial sarcoma, esophageal cancer, lung cancer, bladder cancer, liver cancer, and malignant melanoma. Patients must be positive for HLA-A*02:01 or HLA-A*02:06 and the patient's tumor tissue must be positive for NY-ESO-1 antigen expression. The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells.

The manufacturing of T cells takes about 1 month to complete. The T cells will be given back to the subject through an intravenous infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with advanced solid tumors.

The purpose of this study is to evaluate the safety profile of TBI-1301, to determine the recommended phase 2 (RP2D) dose of TBI-1301 when administered following cyclophosphamide and fludarabine pre-treatment, to evaluate the safety of repeat dosing of TBI-1301, to assess the presence/absence of RCR appearance after TBI-1301 infusion, to assess the presence or absence of clonality by LAM-PCR, and to evaluate evidence of efficacy of TBI-1301 using RECIST v1.1.

Being tested
Cyclophosphamide, TBI-1301, Fludarabine
Keywords
NY-ESO-1 expressing solid tumors in HLA-A2 positive patients
Medical subject headings
Sarcoma, Synovial, Melanoma, Esophageal Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Urinary Bladder Neoplasms, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02869217
Study groupRoleWhat they receive
Cohort B (retreatment)ExperimentalCyclophosphamide 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
Receives: Drug: Cyclophosphamide; Biological: TBI-1301; Drug: Fludarabine
Cohort C (double infusion)ExperimentalCyclophosphamide 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.
Receives: Drug: Cyclophosphamide; Biological: TBI-1301; Drug: Fludarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks

  2. Recommended phase 2 (RP2D) dose o TBI-1301 when administered following cyclophosphamide and fludarabine pre-treatment

    Measured: 8 weeks

Secondary outcomes (1)

  1. Evidence of efficacy (i.e. anti-tumor effect) of TBI-1301 measured using RECIST v1.1

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02869217
Sponsor's protocol ID
1301-02
Status last verified
Nov 2025
First submitted
9 Aug 2016
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cyclophosphamide, TBI-1301 and Fludarabine in people with NY-ESO-1 Expressing Solid Tumors in HLA-A2 Positive Patients and Synovial Sarcoma, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02869217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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