TIL Therapy for Patients With Advanced Solid Tumors

NCT06107894 | Not Yet Recruiting Phase 1

• 1 other identifier: NEOG-N100-K01
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Breast Cancer; Advanced Lung Cancer

Keywords

TIL, IL-2, advanced breast and lung cancer

Outcome Measures

Primary Outcomes (5)

• 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.

  4 weeks

• 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.

  6 months

• Body temperature

  Evaluation of change in vital signs (body temperature).

  6 months

• Respiratory frequency

  Evaluation of change in vital signs (respiratory frequency).

  6 months

• Body pressure

  Evaluation of change in vital signs (body pressure).

  6 months

Secondary Outcomes (5)

• Objective response rate (ORR)

  6 months from baseline of last subject

• Duration of responase (DOR)

  6 months from baseline of last subject

• Progression free survival (PFS)

  6 months from baseline of last subject

• Overall survival (OS)

  6 months from baseline of last subject

• Immune monitoring

  24 weeks

Study Arms (2)

Cohort 1

EXPERIMENTAL

Autologous Tumor-infiltrating lymphocytes

Biological: Tumor-infiltrating lymphocytes

Cohort 2

EXPERIMENTAL

Autologous Tumor-infiltrating lymphocytes, Low dose IL-2

Biological: Tumor-infiltrating lymphocytes; Drug: IL-2

Interventions

Tumor-infiltrating lymphocytes BIOLOGICAL

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

Also known as: NEOG-100

Cohort 1; Cohort 2

IL-2 DRUG

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

Also known as: Aldesleukin

Cohort 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be greater than or equal to 20 years of age on day of singning informed consent.
• Subjects who have at least one breast or lung cancer lesion greater than 1 cm in diameter that has been confirmed imagically within the last 3 months and is scheduled to have tumor tissue collected from the lesion through surgery or biopsy.
• Be willing and able to provide written informed consent for manufacturing.
• Be greater than or equal to 20 years of age.
• Subjects who have histologically and/or cytologically confirmed locally advanced and/or metastatic breast or lung cancer that is not amenable to curative surgical resection
• Subjects who are currently unable to receive standard treatment due to confirmed disease progression or intolerance or imcompatibility after standard treatment which is known to have clinical benefit.
• Have at least one evaluable lesion based on RECIST 1.1 at the time of screening.
• Subjects whose pre-TILs are produced successfully and the possibility of NEOG-100 production is confirmed based on the result of IPC.
• Have a performance status of 0 or 1 on the ECOG Performance Scale.
• Have a life expectancy of at least 12 weeks.
• Hematology at the time of screening and enrollment
• Absolute neotrophil count ≥ 1000/uL without the support of granulocyte colony stimulating factor (G-CSF) within two weeks.
• Hemoglobin ≥ 9.0 g/dL without blood transfusion within two weeks.
• Platelet ≥ 100,000/uL without blood transfusion within two weeks.
• Chemistry at the time of screening and enrollment

You may not qualify if:

• 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
• 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
• 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.
• Unstable antigna and/or myocardial infarction within 12 months prior to screening.
• Thromboembloism or pulmonary embolism within 6 months prior to screening.
• Hypoxia, clinically significant pleural effusion, or electrocardiographic findings within 6 months prior to screening.

Sponsors & Collaborators

• NeogenTC: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Interleukin-2; aldesleukin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Sung-Bae Kim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NeogenTC

CONTACT

82-2-2039-8451; yakim@neogentc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 30, 2023
• Study Start: January 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: May 1, 2026
• Last Updated: October 30, 2023

Record last verified: 2023-10