Solid TumorNCT05745454
A Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor T-cell (CART) in the Treatment of Solid Tumors
A study testing HER2-E-CART cells in people with Solid Tumor, run by su haichuan.
Trial summary
This is a single-arm, investigator-initiated exploratory study.The study is designed to evaluate the safety and the tolerability of HER2-E-CART cells for the treatment of patients with HER2-positive, refractory advanced solid tumors in three dose groups: low, medium and high. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HER2-E-CART cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Dec 2025
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed an informed consent form and were able to complete the study procedures and follow-up examinations and treatment
- Age ≥ 18 years and ≤ 70 years, regardless of gender
- Weight > 40 kg
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 1
- Patients with refractory advanced solid tumors who have failed or are intolerant of existing standard regimens or whose patients have refused standard regimens
- The presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors 1.1 criteria
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- With good organ function
- Positive HER2 cell membrane expression
- Women of childbearing potential must have a pregnancy test with negative results within 7 days prior to initiation of treatment
Who cannot join
- Any systemic antitumor therapy within 2 weeks prior to the single blood collection
- History of organ transplantation
- Pregnant or lactating women
- Uncontrolled infectious disease, such as baseline Hepatitis B Virus DNA ≥ 1000 IU/ml, anti-HIV positive, Hepatitis C Virus-RNA positive
- Other clinically significant active infections
- Other active malignancies within the previous 5 years, such as basal or squamous skin cancer, superficial bladder cancer, or in situ breast cancer that has been completely cured and does not require follow-up treatment subjects are not included
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- Patients with severe autoimmune or immunodeficiency diseases, such as subjects with a confirmed diagnosis of a severe autoimmune disease requiring systemic immunosuppressive (steroid) therapy for a prolonged period of time (more than 2 months) or with immune-mediated symptomatic diseases, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (e.g., Wegener's granulomatosis), etc
- Subjects with known severe allergic reactions to pretreatment drugs such as injectable cyclophosphamide, injectable paclitaxel (albumin-bound), or CAR-T cell preparations including adjuvants, dimethylsulfoxide
- Any unstable systemic disease: including but not limited to unstable angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification ≥ Class III congestive heart failure, severe arrhythmias poorly controlled by medications, liver, kidney or metabolic disease, and hypertension uncontrolled by standard therapy 10
- Those with active bleeding, thrombotic disorders requiring treatment
- Patients with pericardial, thoracic, or abdominal effusions requiring clinical management or intervention
- The presence of known or suspected brain metastases, including central nervous system and spinal cord compressions or meningeal metastases
- Subjects undergoing treatment with systemic steroids or steroid inhalers
- Subjects with any psychiatric disorder, including dementia, altered mental status, that may interfere with informed consent and understanding of relevant questionnaires
- Having participated in another clinical trial within the previous 30 days
- Have received a live or attenuated vaccine within 4 weeks prior to pretreatment
- Those who have been judged by the investigator to have a serious uncontrollable disease or have other conditions that may interfere with receiving treatment in this study and are considered unsuitable
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor T-cell (CART) in the Treatment of Human Epidermalgrowth Factor Receptor-2 (HER2) Positive and Refractory Advanced Solid Tumors
This is a single-arm, investigator-initiated exploratory study.The study is designed to evaluate the safety and the tolerability of HER2-E-CART cells for the treatment of patients with HER2-positive, refractory advanced solid tumors in three dose groups: low, medium and high.
Read the detailed description
This study was a one-arm,investigator-initiated exploratory study. According to the "3+3" principle, three dose groups with increasing dose were set up, namely low, medium and high dose groups, with separate cell counts. A total of 9-12 subjects were enrolled in the group and given intravenous infusion. Dose-limited toxicity was observed from the beginning of preconditioning to 28 days after CAR T infusion.
- Conditions
- Solid Tumor
- Being tested
- HER2-E-CART cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER2-E-CART cellsBiological
E-CAR-T is a novel second-generation CAR-T product targeting HER2 protein
| Study group | Role | What they receive |
|---|---|---|
| HER2-E-CART cells | Experimental | HER2-E-CART cells were intravenously transfused and followed up to 2 years after the last cell transfusion Receives: Biological: HER2-E-CART cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: Adverse events will be collected from the beginning to the end of the study, up to 2 years after the last cell transfusion
Secondary outcomes (15)
Time to peak of serum cytokine Interleukin-2
Time to peak of serum cytokine Interleukin-2
Measured: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Time to peak of serum cytokine Interleukin-6
Time to peak of serum cytokine Interleukin-6
Measured: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Time to peak of serum cytokine Interleukin-10
Time to peak of serum cytokine Interleukin-10
Measured: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Time to peak of serum cytokine Tumor Necrosis Factor-α
Time to peak of serum cytokine Tumor Necrosis Factor-α
Measured: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Time to peak of serum cytokine Tumor Necrosis Factor-γ
Time to peak of serum cytokine Tumor Necrosis Factor-γ
Measured: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Overall survival (OS)
From randomization to the time of death from any cause
Measured: Baseline up to death event.
Objective Response Rate (ORR)
The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Measured: Baseline up to 144 weeks
Disease Control Rate (DCR)
The percentage of patients with advanced or metastatic cancer who have achieved complete response (CR), partial response (PR) and stable disease (SD) to a cancer treatment in clinical trials
Measured: Baseline up to 144 weeks
Duration of Response (DOR)
The time from the date of first documentation of a CR or PR or PD to the date of first documentation of tumor progression.
Measured: Baseline up to 144 weeks
Progression Free Survival (PFS)
The time from the first dose to the first documentation of progressive disease (PD) or death from any cause,whichever occurs first
Measured: Baseline up to 144 weeks
Effects on subjects' health-related quality of life
Quality of life related scale ，for questions 1 to 28, choose a number from 1 to 4, 1 means none and 4 means very good. For questions 29 and 30, choose a number from 1 to 7, with 1 being very poor and 7 being very good.
Measured: Baseline up to 144 weeks
Peak concentration (Cmax)
Maximum plasma drug concentration
Measured: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Area Under The Curve（AUC）
Area under the plasma concentration-time curve Single dose
Measured: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Time to Maximum Plasma Concentration（Tmax）
The time required to reach peak concentration after administration
Measured: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Elimination half-life (t1/2)-Single dose
t1/2 is time it takes for the blood concentration of HER2-E-CART cells or metabolite(s) to drop by half
Measured: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2025 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- su haichuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, su haichuan, Tang-Du Hospital
- Investigators
- Haichuan Su, Doctor, Principal investigator, The Second Affiliated Hospital of PLA Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745454
- Sponsor's protocol ID
- HER2-E-CART
- Status last verified
- Feb 2023
- First submitted
- 8 Dec 2022
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor T-cell (CART) in the Treatment of Human Epidermalgrowth Factor Receptor-2 (HER2) Positive and Refractory Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05745454
- Acronym / sponsor ID
- HER2-E-CART
- Conditions
- Solid Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- su haichuanUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Feb 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.
This is a single-arm, investigator-initiated exploratory study.The study is designed to evaluate the safety and the tolerability of HER2-E-CART cells for the treatment of patients with HER2-positive, refractory advanced solid tumors in three dose groups: low, medium and high.
Detailed description
This study was a one-arm,investigator-initiated exploratory study. According to the "3+3" principle, three dose groups with increasing dose were set up, namely low, medium and high dose groups, with separate cell counts. A total of 9-12 subjects were enrolled in the group and given intravenous infusion. Dose-limited toxicity was observed from the beginning of preconditioning to 28 days after CAR T infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2-E-CART cells | Experimental | Biological: HER2-E-CART cellsHER2-E-CART cells were intravenously transfused and followed up to 2 years after the last cell transfusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily signed an informed consent form and were able to complete the study procedures and follow-up examinations and treatment
- Age ≥ 18 years and ≤ 70 years, regardless of gender
- Weight > 40 kg
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 1
- Patients with refractory advanced solid tumors who have failed or are intolerant of existing standard regimens or whose patients have refused standard regimens
Key exclusion criteria (17 listed)
- Any systemic antitumor therapy within 2 weeks prior to the single blood collection
- History of organ transplantation
- Pregnant or lactating women
- Uncontrolled infectious disease, such as baseline Hepatitis B Virus DNA ≥ 1000 IU/ml, anti-HIV positive, Hepatitis C Virus-RNA positive
- Other clinically significant active infections
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 |
|---|---|---|
| HER2-E-CART cellsE-CAR-T is a novel second-generation CAR-T product targeting HER2 protein | Biological | HER2-E-CART cells |
Primary outcome
Occurence of Adverse event rate
Time frame: Adverse events will be collected from the beginning to the end of the study, up to 2 years after the last cell transfusion
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
15 secondary outcomes
Time to peak of serum cytokine Interleukin-2
Time frame: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Time to peak of serum cytokine Interleukin-6
Time frame: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Time to peak of serum cytokine Interleukin-10
Time frame: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Time to peak of serum cytokine Tumor Necrosis Factor-α
Time frame: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Time to peak of serum cytokine Tumor Necrosis Factor-γ
Time frame: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Overall survival (OS)
Time frame: Baseline up to death event.
Objective Response Rate (ORR)
Time frame: Baseline up to 144 weeks
Disease Control Rate (DCR)
Time frame: Baseline up to 144 weeks
Duration of Response (DOR)
Time frame: Baseline up to 144 weeks
Progression Free Survival (PFS)
Time frame: Baseline up to 144 weeks
Effects on subjects' health-related quality of life
Time frame: Baseline up to 144 weeks
Peak concentration (Cmax)
Time frame: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Area Under The Curve（AUC）
Time frame: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Time to Maximum Plasma Concentration（Tmax）
Time frame: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Elimination half-life (t1/2)-Single dose
Time frame: Within 72 hours before lymphodepletion pretreatment, within 24 hours before and 1 hour after reinfusion, 24 hours, Day 4, Day 7, Day 10, Day 14, Day 28, Day 60, Day 90, Day 180, Day 270, Day 360.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
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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.
Haichuan Su, Doctor principal investigator
The Second Affiliated Hospital of PLA Air Force Medical University
Questions about this trial
What is this clinical trial studying?
A study testing HER2-E-CART cells in people with Solid Tumor, run by su haichuan.
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 9 inclusion and 17 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 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Haichuan Su, Doctor (18629190366, cntdgcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of Adverse event rate (time frame: Adverse events will be collected from the beginning to the end of the study, up to 2 years after the last cell transfusion). 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 27 Feb 2023.