Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the safety of Neo-T in the treatment of advanced solid tumors.
The secondary objective of this study is to evaluate preliminarily the effect of Neo-T in the treatment of advanced solid tumors.
This is a single arm, open label and non-randomized clinical study with two parts.
In Part A, 6 subjects with advanced solid tumors will be enrolled to assess the safety and explore maximum tolerated dose(MTD) or recommended dose of Neo-T.
Depending on results in Part A, the study may proceed to Part B, where 15 subjects with advanced solid tumors will be enrolled to evaluate the effect of Neo-T.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treament of Neo-T | Experimental | Part A dose escalation will use a 3+3 design and will enroll cohorts of 3-6 patients with MEL or NSCLC at escalating doses of 1.2×10^9 cells and 2.4×10^9 cells. Part B will enroll 15 patients with MEL and 5 patients with NSCLC. The administration dose will be identified by the safty of Part A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neo-T | Biological | Patients will recive Neo-T iv on day 0. Three times of cell infusion with an interval of 7 days constitute a cycle,maximum four cycles of treatment for patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as assessed by CTCAE v5.0. | Keep records the adverse events experienced by subjects in 28 days after the first infusion. | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | ORR is defined as the proportion of participants with tumor size reduction(CR,PR) assessed by RECIST 1.1 and iRECIST. | one year |
| Disease Control Rate(DCR) | DCR is defined as the proportion of participants with tumor size reduction(CR,PR) and stable disease(SD) assessed by RECIST 1.1 and iRECIST. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Chen, Doctor | Contact | 027-65650989 | bswhunion@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Chen, Doctor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430023 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D007262 | Infusions, Intravenous |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cyclophosphamide | Drug | Cyclophosphamide 500 mg/m2/day iv on day-5 for one day. |
|
|
| Fludarabine | Drug | Fludarabine 25 mg/m2/day iv on day-5 and day-4 for two days. |
|
|
| Interleukin-2 | Drug | 500,000IU/m2 SC,after each cell infusion,IL-2 will start within 24 hours and every 8-12 hours for up to 6 doses. |
|
|
| one year |
| overall survival(OS) | The time from the first infusion of Investigational Product until death. | one year |
| progression-free survival(PFS) | PFS is defined as the time from the first infusion of Investigational Product until objective tumor progression, as assessed by RECIST 1.1 and iRECIST, or death, whichever occurs first. | one year |
| Duration of Response(DOR) | DOR refers to the period from the first evaluation of tumor as CR or PR to the first evaluation as PD(Progressive Disease) per RECIST1.1 and iRECIST. | one year |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007263 |
| Infusions, Parenteral |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |