Advanced Pancreatic CarcinomaPhase 1/2CAR-TNCT05143151
CD276-targeted Chimeric Antigen Receptor T Cells in Treatment With Advanced Pancreatic Cancer
A Phase 1/2 study testing CD276 CAR-T cells in people with Advanced Pancreatic Carcinoma, run by Shenzhen University General Hospital at 1 site in China.
Trial summary
CD276 (B7-H3) is a member of the B7 costimulatory molecule family. Its mRNA is widely expressed in tissues, but the protein expression is limited. It is expressed in resting fibroblasts, endothelial cells, osteoblasts, amniotic fluid stem cells and other non-immune cells, and The surface of induced antigen-presenting… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Pancreatic Carcinoma
- What is being tested?
- CD276 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to Jul 2024
- Phase
- Phase 1/2
- 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
- Age 18-75 years old (≥18 years old, ≤75 years old), no gender limit;
- The subject voluntarily participates in the study, and he or his legal guardian signs the "Informed Consent";
- Unresectable, locally advanced recurrence or metastatic pancreatic cancer diagnosed by histopathological examination; according to the American Joint Committee on Cancer (AJCC) TNM staging system (2017 version 8), diagnosed as stage III or IV pancreatic cancer ；
- According to the RECIST 1.1 standard, there are clear measurable and evaluable lesions;
- The tumor tissue was confirmed by immunohistochemical staining, and CD276 expression was positive;
- The subject must have received first-line treatment;
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- The subject must be unsuitable for radical treatment, such as radical chemotherapy and/or surgery/immune checkpoint inhibitors, or refuse surgical resection
- Within 2 weeks before cell therapy, have not received antibody drug treatment;
- The ECOG score is 0-2 points;
- The subject has no contraindications for peripheral blood apheresis;
- The expected survival time is more than 3 months
Who cannot join
- Those who have a history of allergies to any of the ingredients in cell products;
- Routine blood examinations have the following conditions: WBC≦1×109/L, absolute centrioles ANC≦0.5×109/L, absolute lymphocyte value ALC≦0.5×109/L, PLT≦25×109/L;
- The following conditions in laboratory tests include, but are not limited to, serum total bilirubin ≥ 1.5 mg/dl; serum ALT or AST greater than 2.5 times the upper limit of normal; blood creatinine ≥ 2.0 mg/dl;
- According to the New York Heart Association (NYHA) cardiac function classification standards, patients with grade III or IV cardiac insufficiency; or echocardiographic examination of left ventricular ejection fraction (LVEF) <50%;
- Abnormal lung function, blood oxygen saturation in indoor air <92%;
- Myocardial infarction, cardiovascular angioplasty or stenting, unstable angina pectoris, or other serious clinical heart diseases within 12 months before enrollment;
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- High blood pressure level 3 and poor blood pressure control with medication;
- Previously suffering from head injury, disturbance of consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
- Patients with autoimmune diseases, immunodeficiencies, or other patients who need immunosuppressive therapy;
- There is an uncontrolled active infection;
- Have used any CAR-T cell products or other genetically modified T cell therapies before;
- Live vaccination within 4 weeks before enrollment;
- HIV, HBV, HCV and TPPA/RPR infected persons, and HBV carriers;
- The subject has a history of alcoholism, drug abuse or mental illness;
- The subject has participated in any other clinical research within 3 months before joining this clinical research;
- Female subjects who have any of the following conditions: a) are pregnant/lactating; or b) have a pregnancy plan during the trial period; or c) have fertility and cannot take effective contraceptive measures;
- The researcher believes that the subject has other conditions that are not suitable for participating in this research
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Li Yu
Shenzhen, Guangdong, 518000
Li Yu, +8675521839178, liyu_gcp@163.com
About this study
Official title: Study on the Efficacy and Safety of CD276-targeted Chimeric Antigen Receptor T Cells (CD276 CAR-T) in Refractory Pancreatic Cancer
CD276 (B7-H3) is a member of the B7 costimulatory molecule family. Its mRNA is widely expressed in tissues, but the protein expression is limited. It is expressed in resting fibroblasts, endothelial cells, osteoblasts, amniotic fluid stem cells and other non-immune cells, and The surface of induced antigen-presenting cells and NK cells. Many studies have revealed that B7-H3 is overexpressed in a variety of tumors, including melanoma, pancreatic cancer, breast cancer, prostate cancer, colorectal cancer and other tumors, and its expression level is closely related to the poor prognosis and clinical outcome of patients . Preclinical studies have confirmed that the expression of CD276 mRNA in pancreatic cancer tissues is significantly higher than that of normal adjacent groups.
Read the detailed description
Traditional treatments have limited efficacy in patients with pancreatic cancer, and molecular targeted therapy also has limited benefits. According to the results of the CONKO-005 clinical trial, compared with the single-agent Gemcitabine (Gemcitabine) treatment, the combined use of Erlotinib (Erolotinib) did not prolong the survival time of pancreatic cancer patients in postoperative adjuvant treatment. However, another phase III clinical result for patients with advanced pancreatic cancer found that compared with gemcitabine monotherapy, the survival of patients in the combined gemcitabine and erlotinib treatment group was significantly improved (6.24 months VS 5.91 months). The one-year survival rate has also improved (23% VS 17%). As a result, the FDA approved the "gemcitabine + erlotinib" combination regimen in 2005 for patients with locally advanced unresectable pancreatic cancer or distant metastases. However, this program only improves survival for about 10 days, making it difficult for the targeted drug erlotinib to achieve greater clinical benefit in the treatment of pancreatic cancer. In February 2019, the FDA approved olapa, an inhibitor that targets poly-ADP ribose polymerase, for the maintenance treatment of patients with metastatic pancreatic cancer who carry BRCA gene mutations, and then the population of patients with metastatic pancreatic cancer who carry BRCA gene mutations The limited quantity limits the scope of clinical application of olaparib. Therefore, it is necessary to explore new anti-pancreatic cancer therapeutic targets.
CD276 (B7-H3) is a member of the B7 costimulatory molecule family. Its mRNA is widely expressed in tissues, but the protein expression is limited. It is expressed in resting fibroblasts, endothelial cells, osteoblasts, amniotic fluid stem cells and other non-immune cells, and The surface of induced antigen-presenting cells and NK cells. Many studies have revealed that B7-H3 is overexpressed in a variety of tumors, including melanoma, pancreatic cancer, breast cancer, prostate cancer, colorectal cancer and other tumors, and its expression level is closely related to the poor prognosis and clinical outcome of patients . Preclinical studies have confirmed that the expression of CD276 mRNA in pancreatic cancer tissues is significantly higher than that of normal adjacent groups.
- Conditions
- Advanced Pancreatic Carcinoma
- Being tested
- CD276 CAR-T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD276 CAR-T cellsBiological
CD276 CAR-T cells infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | CD276 targeted chimeric antigen receptor cells treatment Receives: Biological: CD276 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: up to 1 year
Secondary outcomes (1)
Overall survival rate (OS)
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 posted3 Dec 2021
- Study start1 Jul 2021
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT05143151
- Sponsor's protocol ID
- HEM-ONCO-013
- Acronym
- CAR-T
- Status last verified
- Jul 2021
- First submitted
- 22 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of CD276-targeted Chimeric Antigen Receptor T Cells (CD276 CAR-T) in Refractory Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05143151
- Acronym / sponsor ID
- CAR-T / HEM-ONCO-013
- Conditions
- Advanced Pancreatic Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shenzhen University General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 3 Dec 2021 (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.
CD276 (B7-H3) is a member of the B7 costimulatory molecule family. Its mRNA is widely expressed in tissues, but the protein expression is limited. It is expressed in resting fibroblasts, endothelial cells, osteoblasts, amniotic fluid stem cells and other non-immune cells, and The surface of induced antigen-presenting cells and NK cells. Many studies have revealed that B7-H3 is overexpressed in a variety of tumors, including melanoma, pancreatic cancer, breast cancer, prostate cancer, colorectal cancer and other tumors, and its expression level is closely related to the poor prognosis and clinical outcome of patients . Preclinical studies have confirmed that the expression of CD276 mRNA in pancreatic cancer tissues is significantly higher than that of normal adjacent groups.
Detailed description
Traditional treatments have limited efficacy in patients with pancreatic cancer, and molecular targeted therapy also has limited benefits. According to the results of the CONKO-005 clinical trial, compared with the single-agent Gemcitabine (Gemcitabine) treatment, the combined use of Erlotinib (Erolotinib) did not prolong the survival time of pancreatic cancer patients in postoperative adjuvant treatment. However, another phase III clinical result for patients with advanced pancreatic cancer found that compared with gemcitabine monotherapy, the survival of patients in the combined gemcitabine and erlotinib treatment group was significantly improved (6.24 months VS 5.91 months). The one-year survival rate has also improved (23% VS 17%). As a result, the FDA approved the "gemcitabine + erlotinib" combination regimen in 2005 for patients with locally advanced unresectable pancreatic cancer or distant metastases. However, this program only improves survival for about 10 days, making it difficult for the targeted drug erlotinib to achieve greater clinical benefit in the treatment of pancreatic cancer. In February 2019, the FDA approved olapa, an inhibitor that targets poly-ADP ribose polymerase, for the maintenance treatment of patients with metastatic pancreatic cancer who carry BRCA gene mutations, and then the population of patients with metastatic pancreatic cancer who carry BRCA gene mutations The limited quantity limits the scope of clinical application of olaparib. Therefore, it is necessary to explore new anti-pancreatic cancer therapeutic targets.
CD276 (B7-H3) is a member of the B7 costimulatory molecule family. Its mRNA is widely expressed in tissues, but the protein expression is limited. It is expressed in resting fibroblasts, endothelial cells, osteoblasts, amniotic fluid stem cells and other non-immune cells, and The surface of induced antigen-presenting cells and NK cells. Many studies have revealed that B7-H3 is overexpressed in a variety of tumors, including melanoma, pancreatic cancer, breast cancer, prostate cancer, colorectal cancer and other tumors, and its expression level is closely related to the poor prognosis and clinical outcome of patients . Preclinical studies have confirmed that the expression of CD276 mRNA in pancreatic cancer tissues is significantly higher than that of normal adjacent groups.
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: CD276 CAR-T cellsCD276 targeted chimeric antigen receptor cells treatment |
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 years old (≥18 years old, ≤75 years old), no gender limit;
- The subject voluntarily participates in the study, and he or his legal guardian signs the "Informed Consent";
- Unresectable, locally advanced recurrence or metastatic pancreatic cancer diagnosed by histopathological examination; according to the American Joint Committee on Cancer (AJCC) TNM staging system (2017 version 8), diagnosed as stage III or IV pancreatic cancer ；
- According to the RECIST 1.1 standard, there are clear measurable and evaluable lesions;
- The tumor tissue was confirmed by immunohistochemical staining, and CD276 expression was positive;
Key exclusion criteria (17 listed)
- Those who have a history of allergies to any of the ingredients in cell products;
- Routine blood examinations have the following conditions: WBC≦1×109/L, absolute centrioles ANC≦0.5×109/L, absolute lymphocyte value ALC≦0.5×109/L, PLT≦25×109/L;
- The following conditions in laboratory tests include, but are not limited to, serum total bilirubin ≥ 1.5 mg/dl; serum ALT or AST greater than 2.5 times the upper limit of normal; blood creatinine ≥ 2.0 mg/dl;
- According to the New York Heart Association (NYHA) cardiac function classification standards, patients with grade III or IV cardiac insufficiency; or echocardiographic examination of left ventricular ejection fraction (LVEF) <50%;
- Abnormal lung function, blood oxygen saturation in indoor air <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 |
|---|---|---|
| CD276 CAR-T cellsCD276 CAR-T cells infusion | Biological | Treatment group |
Primary outcome
Objective response rate (ORR)
Time frame: up to 1 year
1 secondary outcome
Overall survival rate (OS)
Time frame: From admission to the end of follow up, up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- 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.
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 Phase 1/2 study testing CD276 CAR-T cells in people with Advanced Pancreatic 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: status not confirmed, as of the sponsor's last update on 3 Dec 2021. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Li Yu (+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?
Objective response rate (ORR) (time frame: up to 1 year). 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 3 Dec 2021.