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Solid TumorsPhase 1NCT02366546

Investigator Initiated Phase 1 Study of TBI-1301

A Phase 1 study testing TBI-1301, Cyclophosphamide and Fludarabine in people with Solid Tumors, run by Mie University at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Following pre-treatment with cyclophosphamide and/or fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to the patients with NY-ESO-1-expressing solid tumors. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Solid Tumors
What is being tested?
TBI-1301, Cyclophosphamide and Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteJapan
Study dates
Mar 2015to Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed solid tumors
  • Solid tumor, which is unresectable, refractory to standard therapy (chemotherapy, radiotherapy, etc)
  • HLA-A*02:01 or HLA-A*02:06 positive
  • NY-ESO-1-expression by PCR or immunohistochemistry
  • ECOG Performance Status, 0 or 1
  • Age >=20 years on consent
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  • No treatment (surgery, chemotherapy, radiotherapy, etc.) and expected sufficient recovery from the treatment at the time of the lymphocytes collection for gene transfer.
  • Life expectancy >=16 weeks after consent
  • No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria:
  • WBC >= 2,500/μL
  • Hemoglobin >= 8.0g/dL
  • Platelets >= 75,000/μL
  • T. bilirubin < 1.5 x ULN
  • AST(GOT), ALT(GPT) < 3.0 x ULN
  • Creatinine < 1.5 x ULN
  • Ability to understand the study contents and to give a written consent at his/her free will.

Who cannot join

  • The following serious complications are excluded from the study;
  • Unstable angina, cardiac infarction, or heart failure
  • Uncontrolled diabetes or hypertension
  • Active infection
  • Obvious interstitial pneumonia or lung fibrosis by chest X-ray
  • Active autoimmune disease requiring steroids or immunosuppressive therapy.
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  • Serious hypersensitivity
  • Tumor cell invasion into CNS
  • Active multiple cancer
  • Positive for HBs antigen or HBV-DNA observed in serum
  • Positive for HCV antibody and HCV-RNA observed in serum
  • Positive for antibodies against HIV or HTLV-1
  • Left Ventricular Ejection Fraction (LVEF): <= 50％
  • Percutaneous Oxygen saturation: < 94％
  • History of serious hypersensitivity reactions to bovine or murine derived substances.
  • History of hypersensitivity reaction to drugs used in this study.
  • Psychological disorder or drug dependency which may have impact on the consent.
  • Pregnant females, lactating females (except when they cease and don't resume lactation) or female and male patients who cannot agree to practice the adequate birth control after the consent during the study
  • Clinically significant systemic illness that in the judgment of the PI or sub-investigator would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Mie University Hospital

    Tsu, Mie-ken

Other trials in Japan

About this study

Official title: Multi-center, Investigator Initiated Phase 1 Study of NY-ESO-1 Specific TCR Gene Transferred T Lymphocytes With Solid Tumors

Following pre-treatment with cyclophosphamide and/or fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to the patients with NY-ESO-1-expressing solid tumors.

Read the detailed description

Following pre-treatment with cyclophosphamide alone or in combination with fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to HLA-A*02:01 or HLA-A*02:06 positive patients with solid tumors which are 1) unresectable, refractory to standard therapy (chemotherapy, radiotherapy, etc), and 2) NY-ESO-1-expressing. The primary objective is to evaluate the safety and in vivo kinetics, and the secondary is to evaluate clinical effect.

Conditions
Solid Tumors
Being tested
TBI-1301, Cyclophosphamide, Fludarabine
Keywords
Adoptive cell transfer, Cell therapy, Immunotherapy, NY-ESO-1, Esophageal cancer, Melanoma, Head and neck cancer, Ovarian cancer, Synovial sarcoma, TCR gene therapy
Medical subject headings
Esophageal Neoplasms, Melanoma, Head and Neck Neoplasms, Ovarian Neoplasms, Sarcoma, Synovial

What participants receive

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

  • TBI-1301Drug

    Also called NY-ESO-1-specific TCR gene transduced T lymphocytes

    TBI-1301(5*10^8 or 5*10^9) is administered.

  • CyclophosphamideDrug

    Also called Endoxan

    Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.

  • FludarabineDrug

    Also called Fludara

    Fludarabine (20mg/m2 x 5 days Intravenous(IV)) is administered as pre-treatment medication of TBI-1301 in combination with cyclophosphamide.

Study groups in NCT02366546
Study groupRoleWhat they receive
Low dose TBI-1301 with pre-treatment 1ExperimentalTBI-1301(5*10^8) single-dose administration with pre-treatment of cyclophosphamide alone.
Receives: Drug: TBI-1301; Drug: Cyclophosphamide
High dose TBI-1301 with pre-treatment 1ExperimentalTBI-1301(5*10^9) single-dose administration with pre-treatment of cyclophosphamide alone.
Receives: Drug: TBI-1301; Drug: Cyclophosphamide
High dose TBI-1301 with pre-treatment 2ExperimentalTBI-1301(5*10^9) single-dose administration with pre-treatment of cyclophosphamide and fludarabine.
Receives: Drug: TBI-1301; Drug: Cyclophosphamide; Drug: Fludarabine
TBI-1301 with pre-treatment 1 or 2ExperimentalArm1, 2 or 3, which is considered as optimal.
Receives: Drug: TBI-1301; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

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

  1. Incidence and grade of adverse events (CTCAE)

    • Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.

    Measured: 4 weeks

  2. Appearance of replication competent retrovirus by PCR

    Confirm no replication competent retrovirus observed.

    Measured: 4 weeks

  3. Appearance of clonality by LAM-PCR

    Confirm no clonality is observed.

    Measured: 4 weeks

  4. Kinetics of TBI-1301 in blood by realtime-PCR

    Evaluate persistence and expansion of transferred TBI-1301.

    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 posted19 Feb 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionSep 2018

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
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02366546
Sponsor's protocol ID
1301-01
Status last verified
Oct 2018
First submitted
12 Feb 2015
Last updated
24 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Ishihara M, Kitano S, Kageyama S, Miyahara Y, Yamamoto N, Kato H, Mishima H, Hattori H, Funakoshi T, Kojima T, Sasada T, Sato E, Okamoto S, Tomura D, Nukaya I, Chono H, Mineno J, Kairi MF, Diem Hoang Nguyen P, Simoni Y, Nardin A, Newell E, Fehlings M, Ikeda H, Watanabe T, Shiku H. NY-ESO-1-specific redirected T cells with endogenous TCR knockdown mediate tumor response and cytokine release syndrome. J Immunother Cancer. 2022 Jun;10(6):e003811. doi: 10.1136/jitc-2021-003811.

    PubMed 35768164

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TBI-1301, Cyclophosphamide and Fludarabine in people with Solid Tumors, run by Mie University at 1 site in Japan.

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 16 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 24 Oct 2018. 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 Japan. 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?

Results are not available in the source record.

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?

Incidence and grade of adverse events (CTCAE) (time frame: 4 weeks). The study lists 4 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 NCT02366546, which also lists 1 linked publication.

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 24 Oct 2018.

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