NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors

NCT05881525 | Recruiting Phase 1

• 1 other identifier: TC-N201-ST
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  Day 0 - Day 730

Secondary Outcomes (7)

• Duration of response

  Day 0 - Day 730

• Progression free survival

  Day 0 - Day 730

• Overall survival

  Day 0 - Day 730

• Maximum Persistence (Cmax) of TC-N201

  Day 0 - Day 730

• Time to Maximum Persistence

  Day 0 - Day 730

Study Arms (1)

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

Biological: TC-N201 cells; Drug: IL-2; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Nab-paclitaxel

Interventions

TC-N201 cells BIOLOGICAL

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.

dose escalation

IL-2 DRUG

Following cell infusion, the patient receives intravenous IL-2. IL-2 improves the survival of TC-N201 cells after infusion.

dose escalation

Fludarabine DRUG

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

dose escalation

Cyclophosphamide DRUG

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

dose escalation

Nab-paclitaxel DRUG

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

dose escalation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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:

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• TCRCure Biopharma Ltd.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

TCRCure Biopharma Ltd.

Chongqing, China

RECRUITING

MeSH Terms

Interventions

Interleukin-2; fludarabine; Cyclophosphamide; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• ning Li, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ning Li, PhD

CONTACT

010-87788713; lining@cicams.ac.cn

Study Design

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

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 31, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)