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

NCT05798546 | Unknown Phase 1 DMC

• 1 other identifier: BGI-003
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Keywords

Melanoma; non-small cell lung cancer; NSCLC; Neoantigen; Adoptive T cell Therapy

Outcome Measures

Primary Outcomes (1)

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

  Keep records the adverse events experienced by subjects in 28 days after the first infusion.

  one month

Secondary Outcomes (5)

• Objective Response Rate(ORR)

  one year

• Disease Control Rate(DCR)

  one year

• overall survival(OS)

  one year

• progression-free survival(PFS)

  one year

• Duration of Response(DOR)

  one year

Study Arms (1)

Treament of Neo-T

EXPERIMENTAL

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.

Biological: Neo-T; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2

Interventions

Neo-T 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.

Also known as: Neoantigen targeting T cells Suspension for Intravenous Infusion

Treament of Neo-T

Cyclophosphamide DRUG

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

Also known as: CTX

Treament of Neo-T

Fludarabine DRUG

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

Also known as: FDR

Treament of Neo-T

Interleukin-2 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.

Also known as: IL-2

Treament of Neo-T

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who are able to cooperate to observe adverse reactions and the effect of the treatment,expected lifetime is greater than six month.
• 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.
• 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%.
• 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).

You may not qualify if:

• 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.
• 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.
• 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.
• The investigator assessed that the subject was unable or unwilling to comply with the requirements of the study protocol.
• The genes correlated to functional defects in antigen presentation, antigen recognition, and cell killing have been detected.
• 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.
• The subject has any disease or medical condition that may affect the safety or effectiveness evaluation of the study treatment.

Sponsors & Collaborators

• BGI, China: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430023, China

RECRUITING

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung

Interventions

Infusions, Intravenous; Cyclophosphamide; fludarabine; Interleukin-2

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Jing Chen, Doctor

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Chen, Doctor

CONTACT

027-65650989; bswhunion@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: September 28, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)