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Advanced Breast CancerPhase 1NCT06107894

TIL Therapy for Patients With Advanced Solid Tumors

A Phase 1 study testing Tumor-infiltrating lymphocytes and IL-2 in people with Advanced Breast Cancer and Advanced Lung Cancer, run by NeogenTC.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is a phase I clinical trial to investigate the safety and tolerability of NEOG-100 in patients with advanced breast cancer and lung cancer. NEOG-100, an autologous tumor infiltrating lymphocytes (TILs), is infused intravenously into the patient after non-myeloablative (NMA) lymphodepletion treatment. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Advanced Breast Cancer, Advanced Lung Cancer
What is being tested?
Tumor-infiltrating lymphocytes and IL-2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
Jan 2024to May 2026
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

None listed.

Who cannot join

  • Subjects who have a history of hypersensitivity to cyclohosphomide, fludarabine, NEOG-100 and its components or who are contraindicated in administration.
  • ex) Cyclophosphamide: subjects taking pentostatin
  • Components of NEOG-100 : 5% human serum albumin, 0.9% saline
  • Cohort 2 only
  • Subjects who have a history of hypersensitivity to aldesleukin (IL-2) and its components or who are contraindicated in administration.
  • Contraindication to dopamine or other pressor-agents
Show all 34Show fewer
  • Have a history of hypersensitivity to phosphoproteins such as recombinant IL-2
  • Have a history of organ allograft or cell therpy
  • Subjects with or who have a history of disease as follow
  • 4-1. Blood cancer including lymphoma, or other malignant tumor except for breast cancer and lung cancer. The enrollment is possible in the following cases;
  • Basal cell carcinoma, squamous carcinoma of the skin, cervical cancer, or in situ carcinoma of breast, that has been cured with no recurrence within the last 3 years prior to screening.
  • Primary tumor in complete remission for more than 5 years prior to screening.
  • 4-2. Unstable antigna and/or myocardial infarction within 12 months prior to screening.
  • 4-3. Thromboembloism or pulmonary embolism within 6 months prior to screening.
  • 4-4. Hypoxia, clinically significant pleural effusion, or electrocardiographic findings within 6 months prior to screening.
  • Brain or central nervous system (CNS) metastases or seizures. Solitary brain metastases may be included if signs of inactivity are confirmed MRI and clinically at least 1 month after completing curative surgery or stereotactic radiotherapy.
  • Heart failure or left ventricular ejection fraction (LVEF) < 45% (NYHA class III/IV).
  • Partial pressure of oxygen in arterial blood (PaO2) < 60mmHg, when resting.
  • Forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) < 0.7.
  • Severe infection or uncontrolled active infection requiring administration of other antibiotics, antifungals, antivirals, etc.
  • Any forms of primary immunodeficiency (ex. severe combined immunodeficiency disease, acquired immunodeficiency syndrome).
  • Active autoimmune disease (ex. autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome, Addion's disease, Hashimoto's thyroiditis Grave's disease).
  • Centrifugal urethral obstruction, cystitis.
  • Decompensation, hemolytic anemia.
  • Subjects who have received or require systemic stroid therapy or other immunosuppressive therapy within 14 days prior to screening. Subjects who have received or require physiologic replacement dose of hydrocortisone or equivalent dose (hydrocortosone up to 30 mg daily, dexamethasone up to 2 mg daily, or prednisone up to 10 mg daily) can enroll.
  • Subjects who have received live or attenuated vaccines within 28 days prior to enrollment.
  • Subjects who have received anti-cancer treatment (ex, chemotherapy, immunotherapy, targeted therapy, hormone therapy, or radiation (chemo) therapy, etc.) within 28 days prior to enrollment.
  • Women who are pregnant or breastfeeding
  • Women of chid-bearing potential or men who do not agree to practice abstinence or to use effective contraception for at least 6 months after administration of NEOG-100. The effective contraception is as follow
  • Hormonal contraception (subcutaneous implants, contraceptives, etc)
  • Implantation of an intrauterine device or system (Loop, hormone-containing intrauterine system)
  • Infertility treatment or surgery (vasectomy, tubal ligation, etc) for subject or subject's spouse
  • Subjects who have received drugs or medical devices for any other clinical trials within 4 weeks before receiving NEOG-100.
  • Subjects who, as determined by the researcher, are inappropriate or impossible for the clinical study.

Trial locations and contacts

No sites are listed yet.

NeogenTC contact

82-2-2039-8451

yakim@neogentc.com

About this study

Official title: Phase I Clinical Trial to Evaluate the Safety and Tolerability of NEOG-100 in Patients With Advanced Breast Cancer and Lung Cancer

This study is a phase I clinical trial to investigate the safety and tolerability of NEOG-100 in patients with advanced breast cancer and lung cancer. NEOG-100, an autologous tumor infiltrating lymphocytes (TILs), is infused intravenously into the patient after non-myeloablative (NMA) lymphodepletion treatment.

Read the detailed description

Study treatment will begin with intravenous NMA lymphodepleiting regimen composed by cyclophosphamide and fludarabine, followed by infusion of NEOG-100. Cyclophosphamide will administered for two days and fludarabine for five days. Patients in Cohort 1 will receive NEOG-100 and patients in Cohort 2 will receive NEOG-100 plus low-dose (2 MIU) IL-2.

Being tested
Tumor-infiltrating lymphocytes, IL-2
Keywords
TIL, IL-2, advanced breast and lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Tumor-infiltrating lymphocytesBiological

    Also called NEOG-100

    After NMA Lymphodepletion, autologous TILs will be intravenous infused into patients.

  • IL-2Drug

    Also called Aldesleukin

    IL-2 will be subcutaneous administrated for 14 days following TILs infusion.

Study groups in NCT06107894
Study groupRoleWhat they receive
Cohort 1ExperimentalAutologous Tumor-infiltrating lymphocytes
Receives: Biological: Tumor-infiltrating lymphocytes
Cohort 2ExperimentalAutologous Tumor-infiltrating lymphocytes, Low dose IL-2
Receives: Biological: Tumor-infiltrating lymphocytes; Drug: IL-2

What is being measured

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

  1. Dose limiting toxicity (DLT)

    DLT is assessed by NCI-CTCAE Ver 5.0.

    For DLT that occurred according to the cohort, the frequency and percentage of each cohort are presented and the optimal use method is identified.

    Measured: 4 weeks

  2. Adverse events

    Analyze adverse evens that occurred after administration of clinical trial drugs.

    Incidence of treatment-emergent adverse events as assessed by NCI-CTCAE Ver 5.0.

    Measured: 6 months

  3. Body temperature

    Evaluation of change in vital signs (body temperature).

    Measured: 6 months

  4. Respiratory frequency

    Evaluation of change in vital signs (respiratory frequency).

    Measured: 6 months

  5. Body pressure

    Evaluation of change in vital signs (body pressure).

    Measured: 6 months

Secondary outcomes (5)

  1. Objective response rate (ORR)

    Evaluation of ORR accorting to RECIST version 1.1 criteria.

    Proportion of subjects with ORR = proportion of subjects with complete response (CR) + proportion of subjects with partial response (PR)

    Measured: 6 months from baseline of last subject

  2. Duration of responase (DOR)

    Evaluation of DOR accorting to RECIST version 1.1 criteria.

    Measured: 6 months from baseline of last subject

  3. Progression free survival (PFS)

    Evaluation of PFS accorting to RECIST version 1.1 criteria.

    Measured: 6 months from baseline of last subject

  4. Overall survival (OS)

    OS is defined as the time from baseline until death from any cause.

    Measured: 6 months from baseline of last subject

  5. Immune monitoring

    Immune monitoring of the peripheral blood by analysis of T cell, T cell receptor (TCR) repertoire, and cytokine release.

    Measured: 24 weeks

Timeline

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

  1. First posted30 Oct 2023
  2. Study startJan 2024 (estimated)
  3. Primary completionSep 2025 (estimated)
  4. Study completionMay 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
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06107894
Sponsor's protocol ID
NEOG-N100-K01
Status last verified
Oct 2023
First submitted
23 Oct 2023
Last updated
30 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tumor-infiltrating lymphocytes and IL-2 in people with Advanced Breast Cancer and Advanced Lung Cancer, run by NeogenTC.

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 0 inclusion and 34 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 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact NeogenTC (82-2-2039-8451, yakim@neogentc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: 4 weeks). The study lists 5 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 NCT06107894.

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 30 Oct 2023.

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