Hepatocellular Carcinoma , CholangiocarcinomaEarly Phase 1NCT04951141
Clinical Study of Intratumoral Injection of CAR-T Cells in the Treatment of Advanced Liver Tumors
A Early Phase 1 study testing anti-GPC3 CAR-T cells in people with Hepatocellular Carcinoma , Cholangiocarcinoma, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.
Trial summary
Objective to study the safety and preliminary efficacy of intratumoral injection of CAR-T cells in the treatment of advanced liver tumors. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Hepatocellular Carcinoma , Cholangiocarcinoma
- What is being tested?
- anti-GPC3 CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 21 Dec 2023
- Phase
- Early 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GPC3 expression was positive by histological examination;
- 18-69 years old;
- The patients with advanced liver tumor who can not be operated and the effect of chemotherapy is poor;
- The patients who received traditional palliative therapy had an expected survival period of more than 4 months;
- Organ status allows clinical application.a. Creatinine < 1.5mg/dl; b. Cardiac ejection index > 55%; c. Heme > 9g / dl, bilirubin < 2.0mg/dl;
- No bleeding and coagulation disorders were found;
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- There was no allergy to contrast medium;
- Contraception: contraceptive measures were taken during clinical application and within 3 months after the last cells transfusion;
- There is no other contraindication for lymphocyte collection;
- Sign informed consent.
Who cannot join
- Pregnant or lactating women;
- Patients need systemic steroids therapy;
- At present, the treatment conditions are as follows : a. Within 30 days before the collection of peripheral blood mononuclear cells,patiens were in other anti-tumor clinical observation period; b. Patients have not recovered from the acute side effects of previous treatment;
- Patients received radiotherapy within 4 weeks after enrollment;
- Patients received other cell modification therapy in the early stage;
- In the screening stage, patients with lymphocyte transfection rate less than 5%, or T cell culture can not expand (< 5 times) patients;
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- Uncontrolled symptoms or other diseases include, but are not limited to, infection, congestive heart failure, unstable angina pectoris, arrhythmia, psychosis, or limiting the social environment that meets the requirements, or the researchers believe that they may bring unpredictable risks;
- Patients with severe acute allergic reactions;
- Patients who participated in other clinical trials;
- Researchers believe that patients are not suitable to participate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, 100039
Yin ying Lu, M.D., luyinying1973@163.com
About this study
Official title: Beijing Immunochina Medical Science & Technology Co., Ltd.
Objective to study the safety and preliminary efficacy of intratumoral injection of CAR-T cells in the treatment of advanced liver tumors.
- Being tested
- anti-GPC3 CAR-T cells
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-GPC3 CAR-T cellsBiological
A single arm, open-label pilot study is designed to determine the safety and efficacy of anti-GPC3 CAR-T cells in patients with GPC3-positive advanced liver cancer.
| Study group | Role | What they receive |
|---|---|---|
| anti-GPC3 CAR-T | Experimental | Not described Receives: Biological: anti-GPC3 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events attributed to the administration of the anti-GPC3 CAR-T cells
Measured: 2 years
Secondary outcomes (2)
Objective response rate (ORR)
Measured: 2 years
Overall survival (OS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Jan 2019
- Primary completion30 Sep 2023 (estimated)
- Study completion21 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma , CholangiocarcinomaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yin ying Lu, M.D., Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951141
- Sponsor's protocol ID
- 2017-003-D
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 6 Jul 2021
- 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 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- ClinicalTrials.gov ID
- NCT04951141
- Acronym / sponsor ID
- 2017-003-D
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 21 Dec 2023 (estimated)
- First posted
- 6 Jul 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.
Objective to study the safety and preliminary efficacy of intratumoral injection of CAR-T cells in the treatment of advanced liver tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-GPC3 CAR-T | Experimental | Biological: anti-GPC3 CAR-T cells |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- GPC3 expression was positive by histological examination;
- 18-69 years old;
- The patients with advanced liver tumor who can not be operated and the effect of chemotherapy is poor;
- The patients who received traditional palliative therapy had an expected survival period of more than 4 months;
- Organ status allows clinical application.a. Creatinine < 1.5mg/dl; b. Cardiac ejection index > 55%; c. Heme > 9g / dl, bilirubin < 2.0mg/dl;
Key exclusion criteria (10 listed)
- Pregnant or lactating women;
- Patients need systemic steroids therapy;
- At present, the treatment conditions are as follows : a. Within 30 days before the collection of peripheral blood mononuclear cells,patiens were in other anti-tumor clinical observation period; b. Patients have not recovered from the acute side effects of previous treatment;
- Patients received radiotherapy within 4 weeks after enrollment;
- Patients received other cell modification therapy in the early stage;
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 |
|---|---|---|
| anti-GPC3 CAR-T cellsA single arm, open-label pilot study is designed to determine the safety and efficacy of anti-GPC3 CAR-T cells in patients with GPC3-positive advanced liver cancer. | Biological | anti-GPC3 CAR-T |
Primary outcome
Adverse events attributed to the administration of the anti-GPC3 CAR-T cells
Time frame: 2 years
2 secondary outcomes
Objective response rate (ORR)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
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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.
Yin ying Lu, M.D. principal investigator
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing anti-GPC3 CAR-T cells in people with Hepatocellular Carcinoma , Cholangiocarcinoma, run by Beijing Immunochina Medical Science & Technology Co., Ltd. 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 10 inclusion and 10 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 6 Jul 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Fei Wu (+8615801390058, wufei@immunochina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events attributed to the administration of the anti-GPC3 CAR-T cells (time frame: 2 years). 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 6 Jul 2021.