UnknownPhase 1

Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02)

China21 participantsStarted 2022-09-28

Plain-language summary

The primary objective of this study is to evaluate the safety of Neo-T in the treatment of advanced solid tumors. The secondary objective of this study is to evaluate preliminarily the effect of Neo-T in the treatment of advanced solid tumors.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Greater than or equal to 18 years of age and less than or equal to 75 years of age; all genders.
✓. Advanced solid tumors including but not limited to some high frequency somatic mutations,such as melanoma,driver mutation-negative non-small cell lung cancer.
✓. Advanced solid tumors patients who are HLA - A0201 /A1101/A2402 subtypes.
✓. Measurable solid tumors with at least one lesion that is resectable or tumor biopsies for DNA extraction.
✓. Patients who failed or were intolerant to standard treatment.
✓. Possess venous access for mononuclear cell collection or intravenous blood collection.
✓. Patients (or their legal representatives) who are able to understand and sign the Informed Consent Form and willing to sign a durable power of attorney.
✓. Clinical performance status of ECOG is 0 or 1.

Exclusion criteria

✕. Pregnant or lactating women.
✕. History of severe immediate hypersensitivity reaction to Neo-T and any of the agents used in this study.
✕. Subjects with a history of organ transplantation.
✕. Subjects with unstable brain metastases.
✕. Any active autoimmune disease or subjects with a history of autoimmune diseases that have been assessed by the investigator to be unsuitable for this study.Including but not limited to the following diseases: such as systemic lupus erythematosus, immune related neuropathy, multiple sclerosis, Guillain Barre syndrome, myasthenia gravis, connective tissue diseases, inflammatory bowel diseases(Crohn's disease and ulcerative colitis), excluding vitiligo, eczema, type I diabetes, rheumatoid arthritis and other joint diseases, Sjogren's syndrome and controlled psoriasis by local medication.
✕. Active systemic infections,for example, acute infections requiring systemic antibiotic, antiviral, or antifungal treatment occur within 2 weeks before enrollment.
✕. Severe liver and kidney function damage(gived treatment is still uncontrollable,and biochemical indicators cannot meet the Exclusion Criteria of 11th), uncontrollable diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or poorly controlled hypertension (systolic pressure\>160mmHg and/or diastolic pressure\>90mmHg); active cardiovascular and cerebrovascular diseases, such as acute stroke,myocardial infarction,unstable angina,congestive heart failure rated as Grade II or above by the New York Heart Association, severe cardiac arrhythmias that cannot be controlled with medication,electrocardiograms show significant abnormalities (three consecutive times with an interval of at least 5 minutes) which have been assessed by the investigator that affect subsequent cellular treatment; mental illness and drug abuse, or any situation that the investigator assessments may increase the risk of this study.
✕. Subjects plan to receive glucocorticoid(the dose of prednisone or alternative drug is more than 10mg per day) or other immunosuppressant within 4 weeks before the administration of lymphocyte clearance.Tips: when there is no active autoimmune disease, it is allowed to use prednisone or alternative drug with a dose less than 10 mg per day; Allowing subjects to use topical, ocular, intra articular, intranasal, and inhaled glucocorticoids for treatment.

What they're measuring

Number of participants with adverse events as assessed by CTCAE v5.0.

Timeframe: one month

Trial details

NCT IDNCT05798546

SponsorBGI, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09

Contact for this trial

Jing Chen, Doctor

027-65650989 bswhunion@163.com

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