Clinical trial · Interventional
TCR-T Cells for the Treatment NY-ESO-1-positive Advanced Solid Tumors
A Single-arm, Open-label, Dose-finding Clinical Study of TCR-T Cells in Patients With HLA-A2-expressing and NY-ESO-1-positive Recurrent or Metastatic Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a Cancer-Testis Antigen (CTA) which is expressed in various tumors. After selected the high affinity TCR gene to NY-ESO-1, the researchers insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. Then the engineered cells are re-infused in the patients with tumors for curing the tumor patient or prolonging life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin-bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Cyclophosphamide Capsules | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| IL-2 | Drug | — | UNRESOLVED |
| TCR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TCR-T cells
- description
- TCR-T cells will be infused to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.
- interventionNames
- Biological: TCR-T cells
- Drug: Fludarabine
- Drug: Cyclophosphamide Capsules
- Drug: Albumin-bound paclitaxel
- Drug: IL-2
Primary outcomes (2)
- measure
- Dose Limiting Toxicity
- timeFrame
- up to Day28
- description
- Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by Investigators, and should be possibly related to TCR-T cells therapy
- measure
- Adverse Event
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail; 2. 18 \~70 years old (gender is not limited;) 3. The expected survival period is at least 3 months; 4. ECOG score of 0-1; 5. Patients with recurrent or metastatic solid tumors confirmed by histopathology; 6. Subjects who failed standard treatment in the past or have no standard treatment currently tor who are judged by the investigator to be unsuitable for current standard treatment for other reasons, and the objective imaging assessment is disease progression; 7. According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation; 8. NY-ESO-1 positive; 9. HLA type is HLA-A2 (except HLA-A\*0203); Exclusion Criteria: 1. Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline; 2. Subjects who have had severe allergic reactions to any drug or its components in this trial in the past; 3. Subjects who have received any investigational drug within 28 days before the infusion of TIL cells, or participated in another clinical study at the same time; 4. Subjects who have other known history of malignant tumors in the past 5 years, except for localized tumors that have been cured, including in situ cervical carcinoma, basal cell carcinoma of the skin, and in situ prostate carcinoma; 5. Patients who have received adoptive cell therapy in the past; 6. According to the judgment of the investigator, the condition of the subject is not suitable for this trial.
References
Publications (0)
Data not yet available