Recurrent Glioblastoma Multiforme (GBM)Phase 1NCT06616727
The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the rGBM
A Phase 1 study testing SNC109 in people with Recurrent Glioblastoma Multiforme (GBM), run by Shanghai Simnova Biotechnology Co.,Ltd. at 1 site in China.
Trial summary
A phase I study to evaluate the safety, tolerance and pharmacokinetics of SNC109 in patients with rGBM Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma Multiforme (GBM)
- What is being tested?
- SNC109
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2023to 31 Dec 2026
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18，both sexes;
- Diagnosed with a history of glioblastoma, and the recurrent glioblastoma has confirmed by histological/molecular pathology (including astrocytoma World Health Organization (WHO) Grade 4);
- Karnofsky (KPS) ≥50;
- The estimated survival time is ≥12 weeks;
- Blood pregnancy tests for women of childbearing age are negative;
- The patient himself/herself, and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form.
Who cannot join
- Known allergies to study drugs or drugs that may be used in the study;
- Severe concurrent diseases in the heart, lungs, liver, or other vital organs;
- Hypertension is poorly controlled or accompanied by hypertensive crisis or hypertensive encephalopathy;
- In addition to the glioblastoma, with other severe central nervous system diseases or complications or aggressive malignancies;
- Long-term use of immunosuppressant drugs, or large doses of steroids;
- Received live or attenuated vaccine or other surgery had no related to GBM within 4 weeks prior to Lymphocytes apheresis;
- Lymphocytes apheresis or cell infusion combined with infection or unexplained fever.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SNC109 in Patients With Recurrent Glioblastoma
A phase I study to evaluate the safety, tolerance and pharmacokinetics of SNC109 in patients with rGBM
Read the detailed description
It is planned to recruit about 50 patients with rGBM subjects. The protocol consists of screening period, Lymphocytes apheresis period, Operation period, pre-infusion evaluation (-2~-1 days), infusion (day 0), infusion observation (day 1-post infusion), and follow-up period (last infusion-720 days). The incidence of dose limitation toxicity (DLT) will be observed within 28 days after the first infusion. Subjects in this study will receive multiple infusions, starting with 5×104 CAR+ T cells/dose in the first subject, and the Safety Review Committee (SRC) will evaluate the subsequent dosing regimen, dose, infusion interval, and number of treatment cycles. Subsequent subjects will be evaluated by the SRC on the basis of available PK and safety data, and the SRC will determine the dosing regimen, dose, infusion interval and number of treatment cycles based on observed evidences.
- Conditions
- Recurrent Glioblastoma Multiforme (GBM)
- Being tested
- SNC109
- Keywords
- GBM
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNC109Drug
SNC-109 CAR-T Cells, first dose from 5×104 CAR+ T Cells, treatment follows the operation and the next dose would be deiced by SRC
| Study group | Role | What they receive |
|---|---|---|
| SNC109 CART | Experimental | After the screening and evaluation, SNC-109 CAR-T Cells will be infusion. Receives: Drug: SNC109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related adverse events
Incidence of adverse events associated with CAR-T cell transfusion within 28 days of the first infusion, abnormal and clinical significant laboratory results
Measured: Up to 28 days after first infusion
DLT
Incidence of DLT associated with CAR-T cell transfusion within 28 days of the first infusion
Measured: Up to 28 days after first infusion
Secondary outcomes (8)
Overall survival (OS) after infusion
The data of Overall survival (OS) after infusion
Measured: within 2 years after first infusion
Time maximum of SNC-109 Cell count and CAR vector copy number
Pharmacokinetic (PK) profile/parameter Tmax
Measured: within 2 years after first infusion
Pharmacokinetic (PK) profile/parameters Peak Plasma Concentration (Cmax) of SNC-109 Cell count and CAR vector copy number
Peak Plasma Concentration (Cmax)
Measured: within 2 years after first infusion
Pharmacokinetic (PK) profile/parameters Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC) of SNC-109 Cell count
Measured: within 2 years after first infusion
Progression free survival (PFS) after infusion
The data of Overall survival (OS) after infusion
Measured: within 2 years after first infusion
Efficacy assesment for the treatment according to iRANO
Assessment of disease response rates according to the Immunological Response Assessment in Neuro-Oncology (iRANO)
Measured: within 2 years after first infusion
Pharmacodynamic (PD) profile/parameters Changes of Cytokines after infusion
Changes of cytokines (such as Interleukin-6, Interleukin-8 etc.) in peripheral blood (PB) and cerebrospinal fluid (CSF) pre-and post- infusion and at each of the main follow-up time points, and the time to recovery
Measured: within 2 years after first infusion
Concentration of Human anti-chimeric antibody (HACA)
Detection of changes in peripheral blood and cerebrospinal fluid Human anti-chimeric antibody (HACA)
Measured: within 2 years after first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start26 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Glioblastoma Multiforme (GBM)Studies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Simnova Biotechnology Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616727
- Sponsor's protocol ID
- SNC109-102
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 27 Sep 2024
- 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SNC109 in Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT06616727
- Acronym / sponsor ID
- SNC109-102
- Conditions
- Recurrent Glioblastoma Multiforme (GBM)
- Keywords
- GBM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Simnova Biotechnology Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Sep 2024 (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.
A phase I study to evaluate the safety, tolerance and pharmacokinetics of SNC109 in patients with rGBM
Detailed description
It is planned to recruit about 50 patients with rGBM subjects. The protocol consists of screening period, Lymphocytes apheresis period, Operation period, pre-infusion evaluation (-2~-1 days), infusion (day 0), infusion observation (day 1-post infusion), and follow-up period (last infusion-720 days). The incidence of dose limitation toxicity (DLT) will be observed within 28 days after the first infusion. Subjects in this study will receive multiple infusions, starting with 5×104 CAR+ T cells/dose in the first subject, and the Safety Review Committee (SRC) will evaluate the subsequent dosing regimen, dose, infusion interval, and number of treatment cycles. Subsequent subjects will be evaluated by the SRC on the basis of available PK and safety data, and the SRC will determine the dosing regimen, dose, infusion interval and number of treatment cycles based on observed evidences.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNC109 CART | Experimental | Drug: SNC109After the screening and evaluation, SNC-109 CAR-T Cells will be infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18，both sexes;
- Diagnosed with a history of glioblastoma, and the recurrent glioblastoma has confirmed by histological/molecular pathology (including astrocytoma World Health Organization (WHO) Grade 4);
- Karnofsky (KPS) ≥50;
- The estimated survival time is ≥12 weeks;
- Blood pregnancy tests for women of childbearing age are negative;
Key exclusion criteria (7 listed)
- Known allergies to study drugs or drugs that may be used in the study;
- Severe concurrent diseases in the heart, lungs, liver, or other vital organs;
- Hypertension is poorly controlled or accompanied by hypertensive crisis or hypertensive encephalopathy;
- In addition to the glioblastoma, with other severe central nervous system diseases or complications or aggressive malignancies;
- Long-term use of immunosuppressant drugs, or large doses of steroids;
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 |
|---|---|---|
| SNC109SNC-109 CAR-T Cells, first dose from 5×104 CAR+ T Cells, treatment follows the operation and the next dose would be deiced by SRC | Drug | SNC109 CART |
Primary outcome
Incidence of treatment related adverse events
Time frame: Up to 28 days after first infusion
Incidence of adverse events associated with CAR-T cell transfusion within 28 days of the first infusion, abnormal and clinical significant laboratory results
DLT
Time frame: Up to 28 days after first infusion
Incidence of DLT associated with CAR-T cell transfusion within 28 days of the first infusion
8 secondary outcomes
Overall survival (OS) after infusion
Time frame: within 2 years after first infusion
Time maximum of SNC-109 Cell count and CAR vector copy number
Time frame: within 2 years after first infusion
Pharmacokinetic (PK) profile/parameters Peak Plasma Concentration (Cmax) of SNC-109 Cell count and CAR vector copy number
Time frame: within 2 years after first infusion
Pharmacokinetic (PK) profile/parameters Area under the plasma concentration versus time curve (AUC)
Time frame: within 2 years after first infusion
Progression free survival (PFS) after infusion
Time frame: within 2 years after first infusion
Efficacy assesment for the treatment according to iRANO
Time frame: within 2 years after first infusion
Pharmacodynamic (PD) profile/parameters Changes of Cytokines after infusion
Time frame: within 2 years after first infusion
Concentration of Human anti-chimeric antibody (HACA)
Time frame: within 2 years after first infusion
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 27 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNC109 in people with Recurrent Glioblastoma Multiforme (GBM), run by Shanghai Simnova Biotechnology 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 6 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 27 Sep 2024. 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?
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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment related adverse events (time frame: Up to 28 days after first infusion). The study lists 2 primary outcomes in all. 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 Sep 2024.