RecruitingEarly Phase 1NCT05438667

TCR-T Cell Therapy on Advanced Solid Tumors

A Prospective, One Arm Clinical Study on the Safety, Efficacy and Pharmacokinetics of KRAS Mutant Antigen Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

18 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The primary aim of this study is to evaluate the efficacy of KRAS mutant antigen specific TCR-T cells in the treatment of patients with advanced solid tumors. The secondary aim is to evaluate the pharmacokinetic/pharmacodynamic characteristics of TCR-T cell therapy in patients with advanced solid tumors and the survival of TCR-T cells. The investigators will evaluate the changes of tumor microenvironment after treatment of advanced solid tumors with KRAS mutant antigen specific TCR-T cells; Evaluating the correlation between cytokines and the occurrence of CRS and neurotoxicity


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of personalized immune cell therapy called TCR-T cell therapy in people with advanced solid tumors (including lung, pancreatic, and colorectal cancers) that have not responded to standard treatments. TCR-T therapy uses your own immune cells that are genetically engineered to recognize specific cancer proteins. **You may be eligible if:** - You are over 18 years old - You have an advanced solid tumor confirmed by biopsy or cytology - Your cancer has stopped responding to standard treatments or no standard treatment exists - Specific tumor types include: non-small cell lung cancer after platinum-based chemotherapy, pancreatic cancer after at least one systemic therapy, colorectal cancer after at least two prior treatment regimens, or other advanced solid tumors **You may NOT be eligible if:** - Your cancer has not yet been tried on standard therapy options - Your overall health or organ function does not meet study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTCR-T therapy

1.Preprocessing strategy: 1. Cyclophosphamide: 300-450mg/m², dissolved in 100ml 0.9% sodium chloride saline, intravenous drip for 60minutes, and 0.4g Mesna injected at 0hour, 4hours and 8 hours after cyclophosphamide,4days and 5 days before TCR-T cell infusion. 2. Fludarabine: 30mg/m² , dissolved in 100ml 0.9% sodium chloride saline, intravenous drip for 30minutes before 3 to 5days before TCR-T cell infusion. 2.Within 3-5 days after pretreatment, subjects will receive a single TCR-T reinfusion with an infusion dose of about 1 × 10⁹~1 × 10¹⁰. 3.Once every 12 hours within 24 hours after TCR-T cell infusion, recombinant human interleukin-2 (injection unit: 500000 units /m², once every 12 hours, subcutaneous injection) will be injected intravenously for 5 days (10 times in total). 4.After 3 months of treatment, If the subject did not occur tumor progression and did not occur adverse events (AEs) of level 3 or higher, a second TCR-T cell reinfusion can be performed.


Locations(1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

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NCT05438667


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