Neo-T in Treating Patients With Advanced Solid Tumors(GI-NeoT-03)
NCT ID: NCT05798533
Last Updated: 2023-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
6 participants
INTERVENTIONAL
2023-01-10
2024-09-30
Brief Summary
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The secondary objective of this study is to evaluate preliminarily the effect of Neo-T in combination with anti-PD1 in patients with solid tumors.
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Detailed Description
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6 to12 patients will be enrolled to assess the safety and explore recommended dose of Neo-T combined with anti-PD1.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment of Neo-T and anti-PD1
Dose escalation will use a 3+3 design and will enroll cohorts of 3-6 patients with MEL or NSCLC at escalating doses of 1.2×10\^9 cells and 3.6×10\^9 cells.
Neo-T
Patients will receive Neo-T iv on day 0. Three times of cell infusion with an interval of 7 days constitute a cycle,maximum four cycles of treatment for patients.
Toripalimab
3mg/kg iv; Within 7 days after the first PBMC collection (day-38±3), the first dose was administered, and thereafter every 2 weeks.
Toripalimab is recommended for patients with Melanoma.
Tislelizumab
200mg iv; Within 7 days after the first PBMC collection (day-38±3), the first dose was administered, and thereafter every 3 weeks.
Tislelizumab is recommended for patients with NSCLC or other tumor types.
Interventions
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Neo-T
Patients will receive Neo-T iv on day 0. Three times of cell infusion with an interval of 7 days constitute a cycle,maximum four cycles of treatment for patients.
Toripalimab
3mg/kg iv; Within 7 days after the first PBMC collection (day-38±3), the first dose was administered, and thereafter every 2 weeks.
Toripalimab is recommended for patients with Melanoma.
Tislelizumab
200mg iv; Within 7 days after the first PBMC collection (day-38±3), the first dose was administered, and thereafter every 3 weeks.
Tislelizumab is recommended for patients with NSCLC or other tumor types.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Advanced solid tumors including but not limited to some high frequency somatic mutations,such as melanoma,driver mutation-negative non-small cell lung cancer.
3. Advanced solid tumors patients who are HLA - A0201 /A1101/A2402 subtypes.
4. Measurable solid tumors with at least one lesion that is resectable or tumor biopsies for DNA extraction.
5. Patients who failed or were intolerant to standard treatment.
6. Possess venous access for mononuclear cell collection or intravenous blood collection.
7. 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.
8. Clinical performance status of ECOG is 0 or 1.
9. Patients who are able to cooperate to observe adverse reactions and the effect of the treatment,expected lifetime is greater than six month.
10. Patients of both genders must be willing to practice birth control from the time of enrollment to three months after treatment on this study,a fertile woman must have a negative pregnancy test.
11. The laboratory test values and the functions of important organs meet the following requirements:1）Serology: HIV antibody(-), hepatitis B DNA(-), hepatitis C antibody(-) and no active syphilis infection; 2）Hematology: Absolute neutrophil count is greater than or equal to 1.5×10\^9/L; WBC is greater than or equal to 3×10\^9/L; lymphocyte count is greater than or equal to 0.8×10\^9/L; Platelet count is greater than or equal to 80×10\^9/L; Hemoglobin is greater than or equal to 90g/L ; 3）Chemistry: Serum ALT/AST is less than or equal to 3 times ULN,except in patients with liver metastasis who must have ALT/AST less than or equal to 5 times ULN; Serum Creatinine is less than or equal to 1.5 times ULN ; Total bilirubin is less than or equal to 1.5 times ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 times ULN;4）Blood Clotting Parameters:Prothrombin Time(PT) and International Normalised Ratio (INR) are less than or equal to 1.5 times ULN;Activated Partial Thromboplastin Time (APTT) is less than or equal to 1.5 times ULN;For subjects who frequently take anticoagulant drugs,their blood clotting parameters can meet the value range adaptive to this special population;5）Left ventricular ejection fraction（LVEF）is more than or equal to 50%.
12. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the first dose of anti-PD1, and toxicities must have recovered to grade 1 or less (except for toxicities such as alopecia or vitiligo).
Exclusion Criteria
2. History of severe immediate hypersensitivity reaction to Neo-T and any of the agents used in this study.
3. Subjects with a history of organ transplantation.
4. Subjects with brain metastases.
5. 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.
6. Active systemic infections,for example, acute infections requiring systemic antibiotic, antiviral, or antifungal treatment occur within 2 weeks before enrollment.
8. 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 first dose of anti-PD1.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.
9. Subjects plan to receive immunomodulatory drugs (such as interferon, GM-CSF, thymosin, gamma globulin, excluding IL-2) within 4 weeks before the first dose of anti-PD1.
10. The investigator assessed that the subject was unable or unwilling to comply with the requirements of the study protocol.
11. The genes correlated to functional defects in antigen presentation, antigen recognition, and cell killing have been detected.
12. With a history of other malignant tumors within the past 5 years; Excluding basal cell carcinoma, thyroid papillary carcinoma, cervical carcinoma in situ, or breast ductal carcinoma in situ.
13. The subject has any disease or medical condition that may affect the safety or effectiveness evaluation of the study treatment.
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Shanghai 10th People's Hospital
OTHER
BGI, China
OTHER
Responsible Party
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Principal Investigators
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Jian Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Yong Chen, Doctor
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Qing Xu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai 10th People's Hospital
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Shanghai Tenth People's Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Li D, Chen C, Li J, Yue J, Ding Y, Wang H, Liang Z, Zhang L, Qiu S, Liu G, Gao Y, Huang Y, Li D, Zhang R, Liu W, Wen X, Li B, Zhang X, Zhang X, Xu RH. A pilot study of lymphodepletion intensity for peripheral blood mononuclear cell-derived neoantigen-specific CD8 + T cell therapy in patients with advanced solid tumors. Nat Commun. 2023 Jun 10;14(1):3447. doi: 10.1038/s41467-023-39225-7.
Guo Z, Yuan Y, Chen C, Lin J, Ma Q, Liu G, Gao Y, Huang Y, Chen L, Chen LZ, Huang YF, Wang H, Li B, Chen Y, Zhang X. Durable complete response to neoantigen-loaded dendritic-cell vaccine following anti-PD-1 therapy in metastatic gastric cancer. NPJ Precis Oncol. 2022 Jun 3;6(1):34. doi: 10.1038/s41698-022-00279-3.
Other Identifiers
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BGI-004
Identifier Type: -
Identifier Source: org_study_id
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