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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-28

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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This is a single arm, open label and non-randomized clinical study with two parts.

In Part A, 6 subjects with advanced solid tumors will be enrolled to assess the safety and explore maximum tolerated dose(MTD) or recommended dose of Neo-T.

Depending on results in Part A, the study may proceed to Part B, where 15 subjects with advanced solid tumors will be enrolled to evaluate the effect of Neo-T.

Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treament of Neo-T

Part A 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 2.4×10\^9 cells.

Part B will enroll 15 patients with MEL and 5 patients with NSCLC. The administration dose will be identified by the safty of Part A.

Group Type EXPERIMENTAL

Neo-T

Intervention Type BIOLOGICAL

Patients will recive 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.

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide 500 mg/m2/day iv on day-5 for one day.

Fludarabine

Intervention Type DRUG

Fludarabine 25 mg/m2/day iv on day-5 and day-4 for two days.

Interleukin-2

Intervention Type DRUG

500,000IU/m2 SC,after each cell infusion,IL-2 will start within 24 hours and every 8-12 hours for up to 6 doses.

Interventions

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Neo-T

Patients will recive 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.

Intervention Type BIOLOGICAL

Cyclophosphamide

Cyclophosphamide 500 mg/m2/day iv on day-5 for one day.

Intervention Type DRUG

Fludarabine

Fludarabine 25 mg/m2/day iv on day-5 and day-4 for two days.

Intervention Type DRUG

Interleukin-2

500,000IU/m2 SC,after each cell infusion,IL-2 will start within 24 hours and every 8-12 hours for up to 6 doses.

Intervention Type DRUG

Other Intervention Names

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Neoantigen targeting T cells Suspension for Intravenous Infusion CTX FDR IL-2

Eligibility Criteria

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Inclusion Criteria

1. Greater than or equal to 18 years of age and less than or equal to 75 years of age; all genders.
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 adptive 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 lymphodepletion regimen, and toxicities must have recovered to grade 1 or less (except for toxicities such as alopecia or vitiligo).

Exclusion Criteria

1. Pregnant or lactating women.
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 unstable 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 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.
9. Subjects plan to receive immunomodulatory drugs (such as interferon, GM-CSF, thymosin, gamma globulin, excluding IL-2) within 4 weeks before the administration of lymphocyte clearance.
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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No