Recurrent GlioblastomaEarly Phase 1NCT04045847
CD147-CART Cells in Patients With Recurrent Malignant Glioma.
A Early Phase 1 study testing CD147-CART in people with Recurrent Glioblastoma and CD147 Positive, run by Xijing Hospital at 1 site in China.
Trial summary
This is a single-center, single-arm, open label and dose escalation clinical study of anti-CD147 CART cells in patients with recurrent malignant glioma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Glioblastoma, CD147 Positive
- What is being tested?
- CD147-CART
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2019to 30 May 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 year and ≤ 65 years, both male and female;
- Recurrent glioblastoma patients confirmed by histology or cytology, which have received standard care of STUPP protocol (TMZ concurrent chemoradiotherapy and adjuvant chemotherapy protocol) after surgery;
- Cerebral ventricle was not opened after glioma surgery;
- More than 6 months after the first glioma surgery;
- Tumor lesions that can be evaluated or measured according to RANO criteria (Measurable enhancement lesions were defined as enhancement lesions with clear upper boundary of CT or MRI, capable of developing on ≥2 axial films with layer thickness of 5 mm, and the length and diameter of each other were >10 mm. If the scanning layer thickness is large, the minimum measurable lesion should be >2 times thick);
- CD147+ was confirmed by histologically diagnosis (IHC staining).
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- Adequate PBMC can be obtained according to the requirements of cell preparation, and there are no other contraindications for lymphocyte collection;
- KPS score ≥70;
- Patient with a life expectancy of greater than three months;
- Patients with entirely informed consent and voluntarily sign the informed consent by themselves or their legal representative.
Who cannot join
- Patients who have received radiotherapy after recurrence;
- Patients who have received corticosteroids or other immunosuppressive agents in the past 2 weeks;
- Patients who have received live vaccine in the past 4 weeks and/or plan to receive live vaccine after participating in the trial;
- Patients who have received chemotherapy in addition to lymphocyte clearance in the past 2 weeks;
- Patients who have not recover from adverse events caused by previous anti-tumor therapy (≤1 according to CTCAE v5.0) prior to enrollment, except for hair loss；
- Patients who have received gene therapy, cell therapy or immune therapy；
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- Patients who have received organ transplantation；
- Patients who cannot able to perform craniocerebral MRI examination;
- Patients with following abnormalities:
- Absolute neutrophil count (ANC)<1.5×109/L， platelet (PLT)<80×109/L or hemoglobin(HGB)<100 g/dL；
- Prothrombin time (PT), activated partial thromboplastin time (APTT) or international normalized ratio (INR) > 1.5×ULN (upper normal value);
- Total bilirubin(TBIL) > 2×ULN; ALT, AST or ALP>3×ULN;
- Serum creatinine (Cr)≥1.5×ULN or glomerular filtration rate (GFR) < 60mL/min×1.73m2；
- Syphilis test (TRUST) positive, Anti-HIV positive, Anti-HCV positive with HCV-RNA level higher than the lower limit of detection (LOD), or HBcAb positive with HBV-DNA level higher than the LOD;
- Left ventricular ejection fraction (LVEF) < 50%;
- An acute bacterial or fungal infection that requires intravenous antibiotics during CAR-T cell therapy;
- Patients who presented with negligent compensatory heart failure (NYHA grade III and IV), unstable angina pectoris, acute myocardial infarction, persistent and clinically significant arrhythmia within 3 months;
- Patients who requires supplemental oxygen to keep saturation greater than 95% and the situation is not expected to resolve within 2 weeks;
- Patients with other malignant tumors that have not been effectively controlled within the past five years;
- Patients who suffering from tuberculosis and not cured;
- Patients with a history of allergic reactions attributed to any agents or compounds involved in this study;
- Patients allergic to contrast agents;
- Patients with a history of mental disorders;
- Patients with a history of drug abuse;
- Pregnant and lactating women, or planning to become pregnant during the study;
- Patients of childbearing age who unwilling or unable to use effective and adequate contraception during and 3 months after the study;
- Patients who enrolled in other clinical trials within 30 days;
- Patients who were considered not suitable for this clinical trial by investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Translational Science Center for Molecular Medicine & Department of Cell Biology
Xi'an, Shaanxi, 710032
Zhinan Chen, PhD, znchen@fmmu.edu.cn
About this study
Official title: A Clinical Study to Investigate the Safety, Tolerance and Efficacy Evaluation of Single-centre, Open-label of Local Treatment of CD147-CART in Recurrent Glioblastoma.
This is a single-center, single-arm, open label and dose escalation clinical study of anti-CD147 CART cells in patients with recurrent malignant glioma.
Read the detailed description
Patients autologous T cells are activated and then engineered to express chimeric antigen receptors (CARs) specific for CD147(CD147-CART). CAR-T cells are expanded in culture and returned to the patient by Ommaya Reservoir at specific cell doses. Three CD147-CART doses patient are planned at 1-week intervals. Serum cytokine level and CAR-T cell number will be measured in whole treatment session.
- Conditions
- Recurrent Glioblastoma, CD147 Positive
- Being tested
- CD147-CART
- Keywords
- glioma, CD147, CAR-T
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD147-CARTBiological
Also called anti-CD147 chimeric antigen receptor T cells
Three doses of CD147-CART cells were injection to intracavity by Ommaya Reservoir.
| Study group | Role | What they receive |
|---|---|---|
| CD147-CART | Experimental | CD147-CAR modified T cells, intracavity injection, 3+3 design with de-escalation in half step, every 7 days for 3 weeks Receives: Biological: CD147-CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and type of adverse events induced by CD147-CART
To assess the safety and tolerability of CD147-CART (anti-CD147 CAR-T cell) for glioma which measured by number and type of adverse events.
Measured: 12 weeks
Secondary outcomes (3)
DLT and MTD of CD147-CART cell
To determine the dose limited toxicity (DLT) and maximum tolerated dose (MTD) of CD147-CART.
Measured: 12 weeks
Clinical Activity of CD147-CART cell
To evaluate treatment response of CD147-CART for glioma
Measured: 2 years
CD147-CART detection in Peripheral Blood
Quantification of CD147-CART cells in blood samples.
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 Aug 2019
- Study start30 May 2019
- Primary completion30 Oct 2020 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045847
- Sponsor's protocol ID
- Chen Zhinan-2
- Status last verified
- May 2019
- First submitted
- 4 Aug 2019
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Investigate the Safety, Tolerance and Efficacy Evaluation of Single-centre, Open-label of Local Treatment of CD147-CART in Recurrent Glioblastoma.
- ClinicalTrials.gov ID
- NCT04045847
- Acronym / sponsor ID
- Chen Zhinan-2
- Conditions
- Recurrent Glioblastoma, CD147 Positive
- Keywords
- glioma, CD147, CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 6 Aug 2019 (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-center, single-arm, open label and dose escalation clinical study of anti-CD147 CART cells in patients with recurrent malignant glioma.
Detailed description
Patients autologous T cells are activated and then engineered to express chimeric antigen receptors (CARs) specific for CD147(CD147-CART). CAR-T cells are expanded in culture and returned to the patient by Ommaya Reservoir at specific cell doses. Three CD147-CART doses patient are planned at 1-week intervals. Serum cytokine level and CAR-T cell number will be measured in whole treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD147-CART | Experimental | Biological: CD147-CARTCD147-CAR modified T cells, intracavity injection, 3+3 design with de-escalation in half step, every 7 days for 3 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 year and ≤ 65 years, both male and female;
- Recurrent glioblastoma patients confirmed by histology or cytology, which have received standard care of STUPP protocol (TMZ concurrent chemoradiotherapy and adjuvant chemotherapy protocol) after surgery;
- Cerebral ventricle was not opened after glioma surgery;
- More than 6 months after the first glioma surgery;
- Tumor lesions that can be evaluated or measured according to RANO criteria (Measurable enhancement lesions were defined as enhancement lesions with clear upper boundary of CT or MRI, capable of developing on ≥2 axial films with layer thickness of 5 mm, and the length and diameter of each other were >10 mm. If the scanning layer thickness is large, the minimum measurable lesion should be >2 times thick);
Key exclusion criteria (28 listed)
- Patients who have received radiotherapy after recurrence;
- Patients who have received corticosteroids or other immunosuppressive agents in the past 2 weeks;
- Patients who have received live vaccine in the past 4 weeks and/or plan to receive live vaccine after participating in the trial;
- Patients who have received chemotherapy in addition to lymphocyte clearance in the past 2 weeks;
- Patients who have not recover from adverse events caused by previous anti-tumor therapy (≤1 according to CTCAE v5.0) prior to enrollment, except for hair loss；
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 |
|---|---|---|
| CD147-CARTAlso: anti-CD147 chimeric antigen receptor T cellsThree doses of CD147-CART cells were injection to intracavity by Ommaya Reservoir. | Biological | CD147-CART |
Primary outcome
Incidence and type of adverse events induced by CD147-CART
Time frame: 12 weeks
To assess the safety and tolerability of CD147-CART (anti-CD147 CAR-T cell) for glioma which measured by number and type of adverse events.
3 secondary outcomes
DLT and MTD of CD147-CART cell
Time frame: 12 weeks
Clinical Activity of CD147-CART cell
Time frame: 2 years
CD147-CART detection in Peripheral Blood
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 7 May 2020.
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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.
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 CD147-CART in people with Recurrent Glioblastoma and CD147 Positive, run by Xijing 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 10 inclusion and 28 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 7 May 2020. 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 Zhinan Chen, PhD (029-84774547, znchen@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and type of adverse events induced by CD147-CART (time frame: 12 weeks). 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 7 May 2020.