Glioblastoma Multiforme, AdultEarly Phase 1NCT05333588
The Safety Study of Autologous TILs Therapy for Patients With Glioblastoma Multiforme.
A Early Phase 1 study testing Tumor Infiltrating Lymphocytes (TIL) in people with Glioblastoma Multiforme, Adult, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
The study is to evaluate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy for patients with maligant glioblastoma multiforme. Autologous TiLs should be given by intravenous infusion after 5 days of lymphodepletion treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioblastoma Multiforme, Adult
- What is being tested?
- Tumor Infiltrating Lymphocytes (TIL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2022to 15 Feb 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 80 years old;
- Has at least one measurable tumor foci;
- ECOG score range : 0-2;
- Expected survival time: ≥ 3 months;
- All screening labs should be performed 7 days prior to registration.The laboratory results need to meet below criteria:
- Absolute white blood cell counts (WBC) ≥ 3.0×10^9/L；
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- Platelet count (PLT) ≥ 100×10^9/L；
- Hematological Absolute neutrophil count (ANC) ≥ 1.5×10^9/L；
- Hemoglobin (HGB) ≥ 90g/L;
- Albumin (absolute) ≥ 2.8g/dL;
- Serum ALT/AST ≤ 2.5×ULN (for patients with liver metastasis ≤ 5×ULN);
- Total bilirubin (TBIL) ≤ 1.5×ULN (for patients with liver metastasis ≤ 2×ULN);
- Renal Serum creatinine OR measured or calculated a creatinine clearance (CR) ≤1.5×ULN OR≥ 50 mL/min for participant;
- AST/ALT (SGOT) ≤ 2.5×ULN (for patients with liver metastasis ≤ 5×ULN);
- International Normalized Ratio (INR) ≤ 1.5;
- Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN;
- Female participant of childbearing potential should have a negative result of human chorionic gonadotropin (HCG) test. The participants must take contraception during the entire clinical follow-up.
- Be willing and able to provide written informed consent/assent for the trial.
Who cannot join
- Has systemic active infection and requiring treatment;
- Has severe physical or mental illness;
- Has active rheumatic disease;
- Has any kinds of organ transplantation;
- Being pregnant or lactating;
- Enrolled in other clinical trials within 4 weeks prior to registration;
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- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C;
- Other conditions that the researcher considered to be excluded;
- Has taken blow treatment before enrollment:
- Received systemic immunosuppressive treatments, aside from corticosteroids within 14 days of treatment;
- Plan to get inactivated vaccine 28 days prior/during, or 60 days post the treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of HeBei Medical University
Shijiazhuang, Hebei, 050000
Na Kuang, +8618630160116, Kuangna@senlangbio.com
About this study
Official title: The Safety and Efficacy Study of Autologous Tumor-infiltrating Lymphocyte (TILs) Therapy Combined With Conventional Chemotherapy for Patients With Advanced Stage of Glioblastoma Multiforme.
The study is to evaluate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy for patients with maligant glioblastoma multiforme. Autologous TiLs should be given by intravenous infusion after 5 days of lymphodepletion treatment.
- Conditions
- Glioblastoma Multiforme, Adult
- Being tested
- Tumor Infiltrating Lymphocytes (TIL)
- Keywords
- glioma, TiLs, Glioblastoma Multiforme
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Infiltrating Lymphocytes (TIL)Biological
Also called TILs
The autologous TILs will be intravenous infused into patients.
| Study group | Role | What they receive |
|---|---|---|
| Tumor infiltrating lymphocyte | Experimental | 1x10^9-5x10^10 of autologous TILs will be adoptive transfer to patients. Receives: Biological: Tumor Infiltrating Lymphocytes (TIL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events related to TiLs infusion
The primary outcome measure of this clinical trial is accessed by the safety of the TILs product. The safety profile for TILs is characterized by its incidence of the adverse events.
Measured: 1 month
Secondary outcomes (2)
Progressional free of survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression. All patients will be followed for a minimum of 2 years.
Measured: Up to 24 months
Objective response rate (ORR)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start15 Feb 2022
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme, AdultStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chunyan Li, academician, Principal investigator, Member of the Chinese Academy of Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333588
- Sponsor's protocol ID
- TILs for Glioblastoma
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2022
- Last updated
- 19 Apr 2022
- 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 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy Study of Autologous Tumor-infiltrating Lymphocyte (TILs) Therapy Combined With Conventional Chemotherapy for Patients With Advanced Stage of Glioblastoma Multiforme.
- ClinicalTrials.gov ID
- NCT05333588
- Acronym / sponsor ID
- TILs for Glioblastoma
- Conditions
- Glioblastoma Multiforme, Adult
- Keywords
- glioma, TiLs, Glioblastoma Multiforme
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 19 Apr 2022 (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.
The study is to evaluate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy for patients with maligant glioblastoma multiforme. Autologous TiLs should be given by intravenous infusion after 5 days of lymphodepletion treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor infiltrating lymphocyte | Experimental | Biological: Tumor Infiltrating Lymphocytes (TIL)1x10^9-5x10^10 of autologous TILs will be adoptive transfer to patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age: 18 to 80 years old;
- Has at least one measurable tumor foci;
- ECOG score range : 0-2;
- Expected survival time: ≥ 3 months;
- All screening labs should be performed 7 days prior to registration.The laboratory results need to meet below criteria:
Key exclusion criteria (11 listed)
- Has systemic active infection and requiring treatment;
- Has severe physical or mental illness;
- Has active rheumatic disease;
- Has any kinds of organ transplantation;
- Being pregnant or lactating;
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 |
|---|---|---|
| Tumor Infiltrating Lymphocytes (TIL)Also: TILsThe autologous TILs will be intravenous infused into patients. | Biological | Tumor infiltrating lymphocyte |
Primary outcome
Number of adverse events related to TiLs infusion
Time frame: 1 month
The primary outcome measure of this clinical trial is accessed by the safety of the TILs product. The safety profile for TILs is characterized by its incidence of the adverse events.
2 secondary outcomes
Progressional free of survival (PFS)
Time frame: Up to 24 months
Objective response rate (ORR)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
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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.
Chunyan Li, academician principal investigator
Member of the Chinese Academy of Engineering
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 Tumor Infiltrating Lymphocytes (TIL) in people with Glioblastoma Multiforme, Adult, run by Hebei Senlang Biotechnology Inc., 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 18 inclusion and 11 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 19 Apr 2022. 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 Na Kuang (+8618630160116, kuangna@senlangbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events related to TiLs infusion (time frame: 1 month). 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 19 Apr 2022.