Advanced Solid TumorsPhase 1NCT05881525
NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors
A Phase 1 study testing TC-N201 cells, IL-2 and Fludarabine in people with Advanced Solid Tumors, run by TCRCure Biopharma Ltd. at 1 site in China.
Trial summary
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a cancer-testis antigen (CTA) which is expressed in various tumors. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- TC-N201 cells, IL-2 and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial;
- Age ≥ 18 years and ≤ 70 years;
- Expected survival time > 3 months;
- ECOG score 0-1;
- Metastatic or recurrent solid tumors confirmed by histopathology;
- Refractory to standard treatment evaluated by radiological assessment;
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- Be able provide fresh or preserved tissue specimen;
- At least 1 measurable lesion (according to RECIST 1.1);
- NY-ESO-1 expression positive: Immunohistochemical staining positive cells ≥25% and positive staining intensity is "++" or above;
- HLA typing is HLA-A2 (excluding HLA-A*0203);
- Hematology should at least meet the following criteria:
- Absolute neutrophil count (ANC) ≥ 1.5× 109/L (±20%)；
- Platelet (PLT） ≥ 75× 109/L (±20%）；
- Hemoglobin (HGB) ≥ 90 g/L (±20%).
- Liver and kidney function are normal:
- Serum creatinine (Cr) ≤ 1.5 times of upper limit of normal (ULN) or creatine clearance ≥ 60 ml/min;
- Serum Alanine aminotransferase (ALT) or/and Aspartate aminotransferase (AST) ≤ 2.5 times of upper limit of normal;
- Total bilirubin (TBIL) ≤ 15 times of upper limit of normal.
- Blood coagulation function is normal: Prothrombin time (PT) ≤ 1.5 ULN, International Normalized Ratio (INR) ≤ 1.5 ULN, or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 ULN;
- Echocardiogram results show: Left ventricular ejection fraction >45%;
- Women of childbearing potential should be ascetic or take contraception since the signing of ICF to 24 weeks or later after the last administration of drug Note: Women of childbearing age who have undergone surgical sterilization or who have already experienced menopause are considered to have no possibility of pregnancy.
- Before the TC-N201 injection was reconstituted, the toxic effects of standard treatment had already recovered, and the corresponding adverse events were judged by the researcher to not pose a safety risk;
- Catheter insertion is feasible and No White Blood Cells collection contraindications.
Who cannot join
- Under pregnancy or lactation, or positive based on blood pregnancy test;
- Severe allergic to related ingredients in the clinical trial;
- Received any other investigational treatment within 4 weeks before the first administration or enrolled in another clinical trial the same time;
- History of other known malignant tumors within the previous 5 years, including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate; Except for localized tumors that have been cured;
- Primary central nerve system (CNS) cancer, or subjects with CNS metastasis after localized treatment;
- Subjects with any active autoimmune disease, a history of autoimmune disease, or a history or syndrome requiring treatment with systemic steroids or immunosuppressive drugs;
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- Immunodeficiency including HIV positive, harvested or natural immunodeficiency;
- Subjects with ≥ grade 3 thromboembolic events within 2 years or under thrombolysis treatment;
- Subjects with hereditary or acquired hemorrhagic disease;
- Have clinical cardiovascular disease or symptoms;
- Subjects with active infection: active infection requiring systemic anti-infective treatment (except topical antibiotics), fever caused by cancer could be enrolled according to the investigator's judgment;
- Subjects with active pulmonary tuberculosis infection detected by medical history or Computed Tomography (CT), or a history of active pulmonary tuberculosis infection within 1 year before enrollment, or a history of active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment;
- Subjects with positive hepatitis B surface antigen or positive hepatitis B core antibody or positive hepatitis C virus antibody;
- Treponema pallidum antibody positive;
- Subjects received major surgery or under severe injury within 4 weeks before TC-N201 cell infusion;
- Subjects who received live vaccine or attenuated live vaccine 28 days before leukapheresis;
- Subjects who have drug addiction history, or alcoholism, drug users;
- Subjects who received cell therapy before enrollment，such as TCR-T，CAR-T and TIL;
- Subjects who have previously received treatment targeting NY-ESO-1;
- Subjects not suitable for the clinical trial according to investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
TCRCure Biopharma Ltd.
Chongqing
xiaochun cheng, 18883244981
miaomiao wang, 18716369572
About this study
Official title: A Phase I/II Clinical Study of TC-N201 Injection for the Treatment of Advanced Solid Tumors With HLA-A2 Expression and Positive NY-ESO-1.
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a cancer-testis antigen (CTA) which is expressed in various tumors. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. The genetically engineered cells are called NY-ESO-1 TCR-T cells. Then the engineered cells are re-infused to the cancer patients to cure the disease or prolong life.
Read the detailed description
This is a single-center, open-label, Phase I clinical study of TCR-T cells for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.
Objective:
To evaluate the safety and efficacy of TCR-T cells for the treatment of advanced solid tumors.
Eligibility:
Adults aging 18-70 with advanced solid tumors
Design:
Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.
Patients will have leukapheresis. Blood will be removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm.
Engineered T cells will be re-infused into the patient. Patients will stay in hospital and be evaluated
- Conditions
- Advanced Solid Tumors
- Being tested
- TC-N201 cells, IL-2, Fludarabine, Cyclophosphamide, Nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-N201 cellsBiological
T cells genetically engineered with a TCR targeting NY-ESO-1 (NY-ESO-1 TCR) that displays specific reactivity against HLA-A2+, NY-ESO-1+ target cells.
IL-2Drug
Following cell infusion, the patient receives intravenous IL-2. IL-2 improves the survival of TC-N201 cells after infusion.
FludarabineDrug
Part of the non-myeloablative lymphocyte-depleting preparative regimen.
CyclophosphamideDrug
Part of the non-myeloablative lymphocyte-depleting preparative regimen.
Nab-paclitaxelDrug
Part of the non-myeloablative lymphocyte-depleting preparative regimen.
| Study group | Role | What they receive |
|---|---|---|
| dose escalation | Experimental | This study uses the "3+3" dose escalation method. The initial dose is Dose 1, the maximum dose that patients can tolerate is determined as the phase II recommended dose (RPIID), and at least 6 patients are receiving RPIID treatment. If patients develop intolerance in Dose 1 (≥3 subjects with DLT), then the subsequent enrolled patients will receive Dose -1 infusion.
Interventions:
Biological: TCR-T cells Drug: IL-2 Drug: Fludarabine Drug: Cyclophosphamide Drug: Nab-Paclitaxel Receives: Biological: TC-N201 cells; Drug: IL-2; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity or Maximum Tolerated Dose (MTD)
Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality, and should be possibly related to TC-N201 cell therapy, and should be unrelated to the disease itself, disease progression, concomitant diseases or concomitant medication. MTD is defined as the highest dose at which ≤1 of 6 patients experienced a DLT or the highest dose level studied if DLTs are not observed at any of the dose levels.
Measured: Day 28 after the first TC-N201 infusion
Overall response rate
The efficacy of TC-N201 will be assessed by the objective response rate (ORR) evaluated according to RECIST 1.1 and iRECIST. ORR is described as patients assessed with partial response (PR) and complete response (CR).
Measured: Day 0 - Day 730
Treatment-related adverse events as assessed by National Cancer Institute general terminology standard for adverse events (NCI CTCAE) v5.0
The type, incidence and severity of adverse events include abnormal laboratory examination results with clinical significance after treatment, abnormal physical examination and blood examination results, bone marrow examination results, etc. Clinical and laboratory adverse events will be classified according to the CTCAE v5.0.
Measured: Day 0 - Day 730
Secondary outcomes (7)
Duration of response
The efficacy of TC-N201 will be assessed by duration of response (DOR). DOR refers to the length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.
Measured: Day 0 - Day 730
Progression free survival
The efficacy of TC-N201 will be assessed by progression free survival (PFS). PFS refers to the time from treatment to progressive disease or death for any reason.
Measured: Day 0 - Day 730
Overall survival
The efficacy of TC-N201 will be assessed by overall survival (OS). OS refers to the time from treatment to death.
Measured: Day 0 - Day 730
Maximum Persistence (Cmax) of TC-N201
Blood samples were collected to measure persistence of infused TC-N201 using polymerase chain reaction of a vector specific sequence in deoxyribonucleic acid (DNA) extracted from peripheral blood mononuclear cell (PBMC).
Measured: Day 0 - Day 730
Time to Maximum Persistence
Blood samples were collected to measure persistence of infused TC-N201 using polymerase chain reaction of a vector specific sequence in DNA extracted from PBMC.
Measured: Day 0 - Day 730
Area Under the Plasma Concentration-time Curve From Zero to Day 28 (AUC [0-28])
Blood samples were collected to measure persistence of infused TC-N201 using polymerase chain reaction of a vector specific sequence in DNA extracted from PBMC.
Measured: Day 28 after the first TC-N201 infusion
Anti-PD-1 single chain antibody concentration
The pharmacodynamics of TC-N201 will be assessed by anti-PD-1 scFv.
Measured: Day 0 - Day 730
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jun 2023
- Primary completion10 Nov 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TCRCure Biopharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ning Li, PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881525
- Sponsor's protocol ID
- TC-N201-ST
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study of TC-N201 Injection for the Treatment of Advanced Solid Tumors With HLA-A2 Expression and Positive NY-ESO-1.
- ClinicalTrials.gov ID
- NCT05881525
- Acronym / sponsor ID
- TC-N201-ST
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- TCRCure Biopharma Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a cancer-testis antigen (CTA) which is expressed in various tumors. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. The genetically engineered cells are called NY-ESO-1 TCR-T cells. Then the engineered cells are re-infused to the cancer patients to cure the disease or prolong life.
Detailed description
This is a single-center, open-label, Phase I clinical study of TCR-T cells for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.
Objective:
To evaluate the safety and efficacy of TCR-T cells for the treatment of advanced solid tumors.
Eligibility:
Adults aging 18-70 with advanced solid tumors
Design:
Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.
Patients will have leukapheresis. Blood will be removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm.
Engineered T cells will be re-infused into the patient. Patients will stay in hospital and be evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose escalation | Experimental | Biological: TC-N201 cells, Drug: IL-2, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Nab-paclitaxelThis study uses the "3+3" dose escalation method. The initial dose is Dose 1, the maximum dose that patients can tolerate is determined as the phase II recommended dose (RPIID), and at least 6 patients are receiving RPIID treatment. If patients develop intolerance in Dose 1 (≥3 subjects with DLT), then the subsequent enrolled patients will receive Dose -1 infusion. Interventions: Biological: TCR-T cells Drug: IL-2 Drug: Fludarabine Drug: Cyclophosphamide Drug: Nab-Paclitaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial;
- Age ≥ 18 years and ≤ 70 years;
- Expected survival time > 3 months;
- ECOG score 0-1;
- Metastatic or recurrent solid tumors confirmed by histopathology;
Key exclusion criteria (20 listed)
- Under pregnancy or lactation, or positive based on blood pregnancy test;
- Severe allergic to related ingredients in the clinical trial;
- Received any other investigational treatment within 4 weeks before the first administration or enrolled in another clinical trial the same time;
- History of other known malignant tumors within the previous 5 years, including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate; Except for localized tumors that have been cured;
- Primary central nerve system (CNS) cancer, or subjects with CNS metastasis after localized treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TC-N201 cellsT cells genetically engineered with a TCR targeting NY-ESO-1 (NY-ESO-1 TCR) that displays specific reactivity against HLA-A2+, NY-ESO-1+ target cells. | Biological | dose escalation |
| IL-2Following cell infusion, the patient receives intravenous IL-2. IL-2 improves the survival of TC-N201 cells after infusion. | Drug | dose escalation |
| FludarabinePart of the non-myeloablative lymphocyte-depleting preparative regimen. | Drug | dose escalation |
| CyclophosphamidePart of the non-myeloablative lymphocyte-depleting preparative regimen. | Drug | dose escalation |
| Nab-paclitaxelPart of the non-myeloablative lymphocyte-depleting preparative regimen. | Drug | dose escalation |
Primary outcome
Dose Limiting Toxicity or Maximum Tolerated Dose (MTD)
Time frame: Day 28 after the first TC-N201 infusion
Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality, and should be possibly related to TC-N201 cell therapy, and should be unrelated to the disease itself, disease progression, concomitant diseases or concomitant medication. MTD is defined as the highest dose at which ≤1 of 6 patients experienced a DLT or the highest dose level studied if DLTs are not observed at any of the dose levels.
Overall response rate
Time frame: Day 0 - Day 730
The efficacy of TC-N201 will be assessed by the objective response rate (ORR) evaluated according to RECIST 1.1 and iRECIST. ORR is described as patients assessed with partial response (PR) and complete response (CR).
Treatment-related adverse events as assessed by National Cancer Institute general terminology standard for adverse events (NCI CTCAE) v5.0
Time frame: Day 0 - Day 730
The type, incidence and severity of adverse events include abnormal laboratory examination results with clinical significance after treatment, abnormal physical examination and blood examination results, bone marrow examination results, etc. Clinical and laboratory adverse events will be classified according to the CTCAE v5.0.
7 secondary outcomes
Duration of response
Time frame: Day 0 - Day 730
Progression free survival
Time frame: Day 0 - Day 730
Overall survival
Time frame: Day 0 - Day 730
Maximum Persistence (Cmax) of TC-N201
Time frame: Day 0 - Day 730
Time to Maximum Persistence
Time frame: Day 0 - Day 730
Area Under the Plasma Concentration-time Curve From Zero to Day 28 (AUC [0-28])
Time frame: Day 28 after the first TC-N201 infusion
Anti-PD-1 single chain antibody concentration
Time frame: Day 0 - Day 730
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ning Li, PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TC-N201 cells, IL-2 and Fludarabine in people with Advanced Solid Tumors, run by TCRCure Biopharma Ltd. at 1 site in China.
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 23 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ning Li, PhD (010-87788713, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity or Maximum Tolerated Dose (MTD) (time frame: Day 28 after the first TC-N201 infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.