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Search / Trial NCT05648994

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

Launched by FUJIAN CANCER HOSPITAL · Dec 12, 2022

Trial Information

Current as of January 22, 2025

Not yet recruiting

Keywords

ClinConnect Summary

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.

TCR-T cells are expanded from peripheral blood, and after ex vivo modification, and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

The primary purpose of this study is to evaluate the safety and tolerability of TCR-T cells in patients with recurrent/metastatic solid tumors.

The second purpose of this study is to preliminarily explore the effectivenes...

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

Zhiyong He

Principal Investigator

Fujian Cancer Hospital

About Fujian Cancer Hospital

Fujian Cancer Hospital is a leading institution in oncology research and treatment, dedicated to advancing cancer care through innovative clinical trials and comprehensive patient support. Located in Fuzhou, China, the hospital is recognized for its commitment to integrating cutting-edge medical technology with evidence-based practices. With a multidisciplinary team of experts, Fujian Cancer Hospital actively engages in clinical research aimed at developing novel therapeutic approaches and improving patient outcomes in cancer treatment. Their focus on collaboration and excellence positions them as a key player in the global effort to enhance cancer care and contribute to the scientific understanding of oncology.

Locations

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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