TCR-T Cells for the Treatment NY-ESO-1-positive Advanced Solid Tumors

NCT05648994 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: FJ002
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity

  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

  up to Day28

• Adverse Event

  The severity and incidence of various adverse events and serious adverse events

  up to 24 months

Secondary Outcomes (3)

• Overall response rate (ORR)

  up to 24 months

• Progression free survival (PFS)

  up to 24 months

• Overall survival

  up to 24 months

Study Arms (1)

TCR-T cells

EXPERIMENTAL

TCR-T cells will be infused to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.

Biological: TCR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide Capsules; Drug: Albumin-bound paclitaxel; Drug: IL-2

Interventions

TCR-T cells BIOLOGICAL

patients will be administration of TCR-T cells

TCR-T cells

Fludarabine DRUG

Part of the non-myeloablative lymphocyte-depleting preparative regime

TCR-T cells

Cyclophosphamide Capsules DRUG

Part of the non-myeloablative lymphocyte-depleting preparative regime

TCR-T cells

Albumin-bound paclitaxel DRUG

Part of the non-myeloablative lymphocyte-depleting preparative regime

TCR-T cells

IL-2 DRUG

Following cell infusion, the patient will be administration high-dose IL-2.

TCR-T cells

Eligibility Criteria

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

You may qualify if:

• Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail;
• \~70 years old (gender is not limited;)
• The expected survival period is at least 3 months;
• ECOG score of 0-1;
• Patients with recurrent or metastatic solid tumors confirmed by histopathology;
• 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;
• According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation;
• NY-ESO-1 positive;
• HLA type is HLA-A2 (except HLA-A\*0203);

You may not qualify if:

• Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline;
• Subjects who have had severe allergic reactions to any drug or its components in this trial in the past;
• 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;
• 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;
• Patients who have received adoptive cell therapy in the past;
• According to the judgment of the investigator, the condition of the subject is not suitable for this trial.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Interventions

fludarabine; Cyclophosphamide; Albumin-Bound Paclitaxel; Interleukin-2

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Lymphokines; Biological Factors

Study Officials

• Zhiyong He

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meifang Li

CONTACT

15985795022; 362952772@qq.com

Zhiyong He

CONTACT

13805086391; heyong1015@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: December 13, 2022
• Study Start: December 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2026
• Last Updated: December 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share