Advanced GliomaNCT05752877
Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced Glioma
A study testing Targeted IL-13 Rα2 UCAR-T cell injection and Targeted B7-H3 UCAR-T cell injection in people with Advanced Glioma and Complication of Chimeric Antigen Receptor (CAR-T) Cell Therapy, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The goal of this clinical trial is to estimate the safety, tolerance and initial efficacy of target IL-13Rα2 or B7-H3 UCAR-T cell injection in the treatment of patients with advanced glioma, as well as the pharmacokinetic characteristics of its metabolites after single and multiple administrations and the biomarkers… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Glioma, Complication of Chimeric Antigen Receptor (CAR-T) Cell Therapy
- What is being tested?
- Targeted IL-13 Rα2 UCAR-T cell injection and Targeted B7-H3 UCAR-T cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 30 Apr 2026
- Phase
- Interventional
- 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
- 18-70 years old, male or female, and the expected survival period is not less than 3 months.
- Advanced, locally advanced or recurrent tumor diagnosed histologically or cytologically.
- Failed in previous standard treatment or gived up treatment for various reasons after failure of first-line treatment.
- Failed in therapy by PD-1 or PD-L1 antibody or stopped administration of PD-1 or PD-L1 antibody for more than 4 weeks.
- At least 1 measurable target lesion (RECIST v1.1).
- 0-2 in ECOG physical state score.
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- Available initial or recurrent tumor tissue for at least 10 stanable and detectable sections.
- Blood routine test: WBC ≥ 3×10^9/L, lymphocyte percentage (LY%) ≥ 15%, hemoglobin Hbo (Hb) ≥ 90g/L, platelet (PLT) ≥ 60×10^9/L.
- Liver and kidney functions: alanine transaminase (ALT) and aspartate transaminase (AST) < 3 times of the normal value, total bilirubin (TBiL) < 1.5 times of the normal value, serum creatinine (SCR) < 1.5 times of the normal value.
- IL-13Rα2 or B7-H3 antigen expression > 50%.
- Volunteered to enroll this study and signed the informed consent with good compliance and cooperation with follow-up.
- Experienced radiotherapy and chemotherapy with an interval of more than 4 week.
Who cannot join
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer ≥ 5 × 10^2 copies/L; HCV antibody and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; CMV DNA test positive; Syphilis test positive.
- Experienced any gene therapy previously.
- Needing long-term immunosuppressants for any reason.
- Any serious and uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and temporal arteritis.
- Severe heart, lung, liver and kidney insufficiency or severe debilitating lung disease; Cardiac function: Grade III or above according to NYHA standard; Liver function: grade C in Child-Puge grading standard; Renal function: chronic kidney disease (CKD) more than stage 4; Renal insufficiency above stage Ⅲ; Lung function: symptoms of severe respiratory failure, involving other organs; Brain function: abnormality of central nervous system or disturbance of consciousness.
- Administrating of systematical steroids currently (except usage inhaled steroids recently or currently).
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- Pregnancy and lactation (the safety of this treatment for unborn children is not clear, and female participants with reproductive potential must have negative serum or urine pregnancy test within 48 hours before administration).
- Allergy to immunotherapy and related drugs.
- Complicated with another tumor.
- History of organ transplantation or waiting for organ transplantation.
- After evaluation by researcher,noncompliance with the requirements of the study protocol was confirmed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Qing Lan, Doctor, 051267784087, szlq006@163.com
About this study
Official title: Clinical Study on Evaluation of Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T Cell Injection in Treatment of Advanced Glioma
The goal of this clinical trial is to estimate the safety, tolerance and initial efficacy of target IL-13Rα2 or B7-H3 UCAR-T cell injection in the treatment of patients with advanced glioma, as well as the pharmacokinetic characteristics of its metabolites after single and multiple administrations and the biomarkers related to efficacy, safety and drug metabolism.
- Being tested
- Targeted IL-13 Rα2 UCAR-T cell injection, Targeted B7-H3 UCAR-T cell injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted IL-13 Rα2 UCAR-T cell injectionBiological
local administration (intracranial cavity or intravertebral injection after surgery): 1 ampoule (about 2-5 ml, 1-5×10^7 cells) for 1-2 minutes each time.
Targeted B7-H3 UCAR-T cell injectionBiological
local administration (intracranial cavity or intravertebral injection after surgery): 1 ampoule (about 2-5 ml, 1-5×10^7 cells) for 1-2 minutes each time.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Not described Receives: Biological: Targeted IL-13 Rα2 UCAR-T cell injection; Biological: Targeted B7-H3 UCAR-T cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The proportion of patients whose tumor size decreases to the expected value and can continue to meet the expected minimum time limit。
Measured: Up to 5 years or complete the follow-up of the last enrolled patient, whichever comes first.
Secondary outcomes (1)
Progression-Free Survival
The time from enrolling into the trial to the first occurrence of disease progression or death from any cause。
Measured: Up to 5 years or complete the follow-up of the last enrolled patient, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 May 2021
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced GliomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Collaborators
- Soochow T-Maximun Biotechnology Co. LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752877
- Sponsor's protocol ID
- SJWKtumor001
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2023
- Last updated
- 3 Mar 2023
- 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 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Evaluation of Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T Cell Injection in Treatment of Advanced Glioma
- ClinicalTrials.gov ID
- NCT05752877
- Acronym / sponsor ID
- SJWKtumor001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Soochow T-Maximun Biotechnology Co. LTD
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 3 Mar 2023 (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 goal of this clinical trial is to estimate the safety, tolerance and initial efficacy of target IL-13Rα2 or B7-H3 UCAR-T cell injection in the treatment of patients with advanced glioma, as well as the pharmacokinetic characteristics of its metabolites after single and multiple administrations and the biomarkers related to efficacy, safety and drug metabolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Biological: Targeted IL-13 Rα2 UCAR-T cell injection, Biological: Targeted B7-H3 UCAR-T cell injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18-70 years old, male or female, and the expected survival period is not less than 3 months.
- Advanced, locally advanced or recurrent tumor diagnosed histologically or cytologically.
- Failed in previous standard treatment or gived up treatment for various reasons after failure of first-line treatment.
- Failed in therapy by PD-1 or PD-L1 antibody or stopped administration of PD-1 or PD-L1 antibody for more than 4 weeks.
- At least 1 measurable target lesion (RECIST v1.1).
Key exclusion criteria (11 listed)
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer ≥ 5 × 10^2 copies/L; HCV antibody and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; CMV DNA test positive; Syphilis test positive.
- Experienced any gene therapy previously.
- Needing long-term immunosuppressants for any reason.
- Any serious and uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and temporal arteritis.
- Severe heart, lung, liver and kidney insufficiency or severe debilitating lung disease; Cardiac function: Grade III or above according to NYHA standard; Liver function: grade C in Child-Puge grading standard; Renal function: chronic kidney disease (CKD) more than stage 4; Renal insufficiency above stage Ⅲ; Lung function: symptoms of severe respiratory failure, involving other organs; Brain function: abnormality of central nervous system or disturbance of consciousness.
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 |
|---|---|---|
| Targeted IL-13 Rα2 UCAR-T cell injectionlocal administration (intracranial cavity or intravertebral injection after surgery): 1 ampoule (about 2-5 ml, 1-5×10^7 cells) for 1-2 minutes each time. | Biological | Interventional Group |
| Targeted B7-H3 UCAR-T cell injectionlocal administration (intracranial cavity or intravertebral injection after surgery): 1 ampoule (about 2-5 ml, 1-5×10^7 cells) for 1-2 minutes each time. | Biological | Interventional Group |
Primary outcome
Objective Response Rate
Time frame: Up to 5 years or complete the follow-up of the last enrolled patient, whichever comes first.
The proportion of patients whose tumor size decreases to the expected value and can continue to meet the expected minimum time limit。
1 secondary outcome
Progression-Free Survival
Time frame: Up to 5 years or complete the follow-up of the last enrolled patient, whichever comes first.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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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 study testing Targeted IL-13 Rα2 UCAR-T cell injection and Targeted B7-H3 UCAR-T cell injection in people with Advanced Glioma and Complication of Chimeric Antigen Receptor (CAR-T) Cell Therapy, run by Second Affiliated Hospital of Soochow University 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 12 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 3 Mar 2023. 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.
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 Qing Lan, Doctor (+86-512-67784087, szlq006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to 5 years or complete the follow-up of the last enrolled patient, whichever comes first.). 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 3 Mar 2023.