Phase I Clinical Trial to Evaluate the Safety and Tolerability of NEOG-100 in Patients With Advanced Breast Cancer and Lung Cancer
Overview
- Phase
- Phase 1
- Intervention
- Tumor-infiltrating lymphocytes
- Conditions
- Advanced Breast Cancer
- Sponsor
- NeogenTC
- Enrollment
- 12
- Primary Endpoint
- Body temperature
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Infusion Inclusion Criteria:
- •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.
Exclusion Criteria
- •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;
Arms & Interventions
Cohort 1
Autologous Tumor-infiltrating lymphocytes
Intervention: Tumor-infiltrating lymphocytes
Cohort 2
Autologous Tumor-infiltrating lymphocytes, Low dose IL-2
Intervention: Tumor-infiltrating lymphocytes
Cohort 2
Autologous Tumor-infiltrating lymphocytes, Low dose IL-2
Intervention: IL-2
Outcomes
Primary Outcomes
Body temperature
Time Frame: 6 months
Evaluation of change in vital signs (body temperature).
Respiratory frequency
Time Frame: 6 months
Evaluation of change in vital signs (respiratory frequency).
Body pressure
Time Frame: 6 months
Evaluation of change in vital signs (body pressure).
Dose limiting toxicity (DLT)
Time Frame: 4 weeks
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.
Adverse events
Time Frame: 6 months
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.
Secondary Outcomes
- Progression free survival (PFS)(6 months from baseline of last subject)
- Overall survival (OS)(6 months from baseline of last subject)
- Objective response rate (ORR)(6 months from baseline of last subject)
- Immune monitoring(24 weeks)
- Duration of responase (DOR)(6 months from baseline of last subject)