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Recurrent Glioblastoma MultiformePhase 1NCT05868083

The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the Recurrent Glioblastoma

A Phase 1 study testing SNC-109 CAR-T Cells in people with Recurrent Glioblastoma Multiforme, run by Shanghai Simnova Biotechnology Co.,Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single arm clinical study to estimate the safety, tolerability and pharmacokinetic (PK) characteristics of Chimeric Antigen Receptor-modified T cells (CAR-T) SNC-109 in patients with recurrent glioblastoma (r-GBM) and preliminarily evaluate the effectiveness, the immunogenicity of the product, as well as… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Recurrent Glioblastoma Multiforme
What is being tested?
SNC-109 CAR-T Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
24 Jun 2022to Aug 2024
Phase
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 and ≤70，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) ≥60;
  • The estimated survival time is ≥8 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.

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing

    Ling Chen, 8610-66887329, chen_ling301@163.com

    Ling Chen, MD/PhD

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of SNC-109 CAR-T Cell Therapy in Subjects With Recurrent Glioblastoma

This is a single arm clinical study to estimate the safety, tolerability and pharmacokinetic (PK) characteristics of Chimeric Antigen Receptor-modified T cells (CAR-T) SNC-109 in patients with recurrent glioblastoma (r-GBM) and preliminarily evaluate the effectiveness, the immunogenicity of the product, as well as their correlation between the changes of cytokines from baseline level after cellular infusion.

Read the detailed description

It is planned to recruit about 16 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 2×104 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.

Being tested
SNC-109 CAR-T Cells
Keywords
CAR-T, GBM
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SNC-109 CAR-T CellsDrug

    SNC-109 CAR-T Cells, first dose from 2×104 CAR+ T Cells, treatment follows the operation and the next dose would be deiced by SRC

Study groups in NCT05868083
Study groupRoleWhat they receive
SNC-109 CAR-T CellsExperimentalAfter the operation and pre-infusion evaluation, SNC-109 CAR-T Cells will be evaluated.
Receives: Drug: SNC-109 CAR-T Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment related adverse everts

    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

  2. Cmax of SNC-109 Cell count

    SNC-109 cell count maximum (Cmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)

    Measured: within 2 years after first infusion

  3. Tmax of SNC-109 Cell count

    SNC-109 cell count time to Cmax(Tmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)

    Measured: within 2 years after first infusion

  4. AUC of SNC-109 Cell count

    SNC-109 cell count area under the curve (AUC) in peripheral blood (PB) and cerebrospinal fluid (CSF)

    Measured: within 2 years after first infusion

  5. Cmax of SNC-109 CAR vector copy number

    SNC-109 CAR vector copy number (VCN) maximum (Cmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)

    Measured: within 2 years after first infusion

  6. Tmax of SNC-109 CAR vector copy number

    SNC-109 CAR vector copy number (VCN) time to Cmax(Tmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)

    Measured: within 2 years after first infusion

  7. AUC of SNC-109 CAR vector copy number

    SNC-109 CAR vector copy number (VCN) area under the curve (AUC) in peripheral blood (PB) and cerebrospinal fluid (CSF)

    Measured: within 2 years after first infusion

  8. Other relevant PK parameters

    Other relevant PK parameters in peripheral blood (PB) and cerebrospinal fluid (CSF)

    Measured: within 2 years after first infusion

Secondary outcomes (6)

  1. Objective response rate (ORR) after infusion

    The data of objective response rate (ORR) after infusion

    Measured: within 2 years after first infusion

  2. Progression free survival (PFS) after infusion

    The data of Progression free survival (PFS) after infusion

    Measured: within 2 years after first infusion

  3. Overall survival (OS) after infusion

    The data of Overall survival (OS) after infusion

    Measured: within 2 years after first infusion

  4. 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

  5. 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

  6. 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.

  1. First posted22 May 2023
  2. Study start24 Jun 2022
  3. Primary completionMay 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

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
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05868083
Sponsor's protocol ID
SNC-109-101
Status last verified
May 2023
First submitted
18 Apr 2023
Last updated
23 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SNC-109 CAR-T Cells in people with Recurrent Glioblastoma Multiforme, 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: status not confirmed, as of the sponsor's last update on 23 Feb 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment related adverse everts (time frame: Up to 28 days after first infusion). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05868083.

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 23 Feb 2024.

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