Solid TumorPhase 1NCT05798546
Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02)
A Phase 1 study testing Neo-T, Cyclophosphamide and Fludarabine in people with Solid Tumor, run by BGI, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Neo-T, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2022to Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430023
Jing Chen, Doctor, 027-65650989, bswhunion@163.com
About this study
Official title: The Safety,Tolerance and Efficacy of Neoantigen Targeting T Cells Suspension for Intravenous Infusion(Neo-T) to Advanced Solid Tumor
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.
Read the detailed description
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
- Solid Tumor
- Being tested
- Neo-T, Cyclophosphamide, Fludarabine, Interleukin-2
- Keywords
- Melanoma, non-small cell lung cancer, NSCLC, Neoantigen, Adoptive T cell Therapy
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-TBiological
Also called Neoantigen targeting T cells Suspension for Intravenous Infusion
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.
CyclophosphamideDrug
Also called CTX
Cyclophosphamide 500 mg/m2/day iv on day-5 for one day.
FludarabineDrug
Also called FDR
Fludarabine 25 mg/m2/day iv on day-5 and day-4 for two days.
Interleukin-2Drug
Also called IL-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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Neo-T; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (5)
Objective Response Rate(ORR)
ORR is defined as the proportion of participants with tumor size reduction(CR,PR) assessed by RECIST 1.1 and iRECIST.
Measured: one year
Disease Control Rate(DCR)
DCR is defined as the proportion of participants with tumor size reduction(CR,PR) and stable disease(SD) assessed by RECIST 1.1 and iRECIST.
Measured: one year
overall survival(OS)
The time from the first infusion of Investigational Product until death.
Measured: one year
progression-free survival(PFS)
PFS is defined as the time from the first infusion of Investigational Product until objective tumor progression, as assessed by RECIST 1.1 and iRECIST, or death, whichever occurs first.
Measured: one year
Duration of Response(DOR)
DOR refers to the period from the first evaluation of tumor as CR or PR to the first evaluation as PD(Progressive Disease) per RECIST1.1 and iRECIST.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start28 Sep 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BGI, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Chen, Doctor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798546
- Sponsor's protocol ID
- BGI-003
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety,Tolerance and Efficacy of Neoantigen Targeting T Cells Suspension for Intravenous Infusion(Neo-T) to Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT05798546
- Acronym / sponsor ID
- BGI-003
- Conditions
- Solid Tumor
- Keywords
- Melanoma, non-small cell lung cancer, NSCLC, Neoantigen, Adoptive T cell Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- BGI, ChinaUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treament of Neo-T | Experimental | Biological: Neo-T, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-2Part 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neo-TAlso: Neoantigen targeting T cells Suspension for Intravenous InfusionPatients 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. | Biological | Treament of Neo-T |
| CyclophosphamideAlso: CTXCyclophosphamide 500 mg/m2/day iv on day-5 for one day. | Drug | Treament of Neo-T |
| FludarabineAlso: FDRFludarabine 25 mg/m2/day iv on day-5 and day-4 for two days. | Drug | Treament of Neo-T |
| Interleukin-2Also: IL-2500,000IU/m2 SC,after each cell infusion,IL-2 will start within 24 hours and every 8-12 hours for up to 6 doses. | Drug | Treament of Neo-T |
Primary outcome
Number of participants with adverse events as assessed by CTCAE v5.0.
Time frame: one month
Keep records the adverse events experienced by subjects in 28 days after the first infusion.
5 secondary outcomes
Objective Response Rate(ORR)
Time frame: one year
Disease Control Rate(DCR)
Time frame: one year
overall survival(OS)
Time frame: one year
progression-free survival(PFS)
Time frame: one year
Duration of Response(DOR)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Chen, Doctor principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neo-T, Cyclophosphamide and Fludarabine in people with Solid Tumor, run by BGI, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Chen, Doctor (027-65650989, bswhunion@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as assessed by CTCAE v5.0. (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.