Advanced Pancreatic CarcinomaNCT05620732
Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T
A study testing Claudin18.2 CAR-T cells in people with Advanced Pancreatic Carcinoma and Advanced Gastric Carcinoma, run by Shenzhen University General Hospital at 1 site in China.
Trial summary
The efficacy of advanced pancreatic cancer and gastric cancer needs to be further improved. Claudin is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in gastric cancer and pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Pancreatic Carcinoma, Advanced Gastric Carcinoma
- What is being tested?
- Claudin18.2 CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18-75 (≥ 18, ≤ 75), regardless of gender;
- Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form;
- Non resectable, locally late recurrent or metastatic gastric cancer or pancreatic cancer confirmed by histopathology; Patients with gastric cancer or pancreatic cancer diagnosed as stage III or IV according to the TNM staging system of the American Joint Commission on Cancer (AJCC) (8th edition in 2017);
- According to RECIST 1.1 standard, there are clearly measurable and evaluable lesions;
- Immunohistochemical staining confirmed that Claudin 18.2 was moderately and highly expressed in tumor tissues;
- Subjects must have received the first and second line standard treatment scheme;
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- The subject must not be suitable for receiving radical treatment methods, such as radical chemotherapy and radiotherapy and/or surgery/immunosuppressant at the checkpoint, or refuse surgical resection
- Within 2 weeks before cell therapy, no antibody drugs were used;
- ECOG score is 0-2;
- The subjects had no contraindication for peripheral blood collection;
- The expected survival period is more than 3 months.
Who cannot join
- People who have a history of allergy to any component in cell products;
- The following conditions occur in blood routine examination: WBC ≤ 1 × 109/L, absolute value of central granulocyte ANC ≤ 0.5 × 109/L, absolute value of lymphocyte ALC ≤ 0.5 × 109/L , PLT≦25 × 109/L ；
- The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg/dl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg/dl;
- According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)<50% by echocardiography;
- Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%;
- Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment;
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- Grade 3 hypertension and poor blood pressure control after drug treatment;
- Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past;
- Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment;
- There is uncontrolled active infection;
- Have used any CAR-T cell product or other genetically modified T cell therapy before;
- Live vaccine inoculation within 4 weeks before enrollment;
- HIV, HBV, HCV and TPPA/RPR positive persons, and HBV carriers;
- Subjects have a history of alcohol abuse, drug abuse or mental illness;
- Subjects have participated in any other clinical research within 3 months before joining this clinical research;
- Female subjects have any of the following conditions: a) are in pregnancy/lactation; Or b) having a pregnancy plan during the trial; Or c) is fertile and unable to take effective contraceptive measures;
- The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Li Yu
Shenzhen, Guangdong, 518000
Li Yu, +8675521839178, liyu_gcp@163.com
About this study
Official title: Efficacy and Safety of Claudin18.2CAR-T in Advanced Pancreatic Cancer and Gastric Carcinoma
The efficacy of advanced pancreatic cancer and gastric cancer needs to be further improved. Claudin is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in gastric cancer and pancreatic cancer. Preclinical studies suggest that Claudin18.2CAR-T can effectively improve the remission rate of patients with advanced solid tumors.
Read the detailed description
The efficacy of advanced pancreatic cancer and gastric cancer needs to be further improved.
Claudin is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in gastric cancer and pancreatic cancer. Preclinical studies suggest that Claudin18.2CAR-T can effectively improve the remission rate of patients with advanced solid tumors.
Investigators aim to testify to the safety and efficacy of Claudin18.2CAR-T cells in advanced pancreatic cancer and gastric cancer.
- Being tested
- Claudin18.2 CAR-T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Claudin18.2 CAR-T cellsBiological
patients treated with Claudin18.2 CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients treated with Claudin 18.2 CAR-T cells. Receives: Biological: Claudin18.2 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE/SAE
adverse events/ severe adverse events
Measured: From date of infusion to 30 days after infusion
Secondary outcomes (1)
ORR
overall response rate
Measured: From admission to the end of follow up, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Oct 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CarcinomaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YuLi, Shenzhen University General Hospital
- Investigators
- Li Yu, Dr, Principal investigator, Shenzhen University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620732
- Sponsor's protocol ID
- HEM-ONCO-025
- Status last verified
- Nov 2022
- First submitted
- 11 Nov 2022
- Last updated
- 22 Nov 2022
- 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 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Claudin18.2CAR-T in Advanced Pancreatic Cancer and Gastric Carcinoma
- ClinicalTrials.gov ID
- NCT05620732
- Acronym / sponsor ID
- HEM-ONCO-025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shenzhen University General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 17 Nov 2022 (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 efficacy of advanced pancreatic cancer and gastric cancer needs to be further improved. Claudin is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in gastric cancer and pancreatic cancer. Preclinical studies suggest that Claudin18.2CAR-T can effectively improve the remission rate of patients with advanced solid tumors.
Detailed description
The efficacy of advanced pancreatic cancer and gastric cancer needs to be further improved.
Claudin is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in gastric cancer and pancreatic cancer. Preclinical studies suggest that Claudin18.2CAR-T can effectively improve the remission rate of patients with advanced solid tumors.
Investigators aim to testify to the safety and efficacy of Claudin18.2CAR-T cells in advanced pancreatic cancer and gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Biological: Claudin18.2 CAR-T cellsPatients treated with Claudin 18.2 CAR-T cells. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75 (≥ 18, ≤ 75), regardless of gender;
- Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form;
- Non resectable, locally late recurrent or metastatic gastric cancer or pancreatic cancer confirmed by histopathology; Patients with gastric cancer or pancreatic cancer diagnosed as stage III or IV according to the TNM staging system of the American Joint Commission on Cancer (AJCC) (8th edition in 2017);
- According to RECIST 1.1 standard, there are clearly measurable and evaluable lesions;
- Immunohistochemical staining confirmed that Claudin 18.2 was moderately and highly expressed in tumor tissues;
Key exclusion criteria (17 listed)
- People who have a history of allergy to any component in cell products;
- The following conditions occur in blood routine examination: WBC ≤ 1 × 109/L, absolute value of central granulocyte ANC ≤ 0.5 × 109/L, absolute value of lymphocyte ALC ≤ 0.5 × 109/L , PLT≦25 × 109/L ；
- The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg/dl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg/dl;
- According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)<50% by echocardiography;
- Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%;
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 |
|---|---|---|
| Claudin18.2 CAR-T cellspatients treated with Claudin18.2 CAR-T cells | Biological | Treatment group |
Primary outcome
AE/SAE
Time frame: From date of infusion to 30 days after infusion
adverse events/ severe adverse events
1 secondary outcome
ORR
Time frame: From admission to the end of follow up, up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- 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.
Li Yu, Dr principal investigator
Shenzhen University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Claudin18.2 CAR-T cells in people with Advanced Pancreatic Carcinoma and Advanced Gastric Carcinoma, run by Shenzhen University General Hospital 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 11 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: looking for participants now, as of the sponsor's last update on 22 Nov 2022. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Yu, Dr (+8675521839178, liyu@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE/SAE (time frame: From date of infusion to 30 days after infusion). 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 22 Nov 2022.