GliomaPhase 1ENHANCINGNCT06355908
IL13Rα2 CAR-T for Patients With r/r Glioma
A Phase 1 study testing IL13Rα2 CAR-T in people with Glioma, run by Yang Zhang at 1 site in China.
Trial summary
This is a dose exploration clinical trial to assess the safety and feasibility of the IL13Ra2-targeted CAR-T in glioma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioma
- What is being tested?
- IL13Rα2 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2024to 1 May 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-75 years (including 18 and 75 years old).
- Karnofsky scale score (KPS)≥50.
- Subjects with WHO grade 4 gliomas who have relapsed or progressed during or after standard treatments such as surgery, radiotherapy, and chemotherapy.
- Tumor with IL13Rα2 positive expression.
- Availability in collecting peripheral blood mononuclear cells (PBMCs).
- Adequate laboratory values and adequate organ function.
- Patients with childbearing/fathering potential must agree to use highly effective contraception.
Who cannot join
- Pregnant or breastfeeding females.
- Contraindication to bevacizumab.
- Within 5 days prior to the infusion of CAR-T cells, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids (not including inhaled corticosteroid).
- Comorbid with other uncontrolled malignancy.
- Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or tuberculosis infection.
- Autoimmune diseases.
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- Severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes.
- Subjects who have previously received cell therapy (such as TCR-T, CAR-T, TIL, etc.).
- Subjects with other conditions that would interfere trial participation at the investigator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability and Efficacy of Enhanced IL-13Rα2 Targeted Chimeric Antigen Receptor T Cell Immunotherapy Against Recurrent/Refractory Grade 4 Glioma
This is a dose exploration clinical trial to assess the safety and feasibility of the IL13Ra2-targeted CAR-T in glioma.
Read the detailed description
Interleukin 13 receptor subunit alpha-2 (IL13Ra2A) is a high-affinity membrane receptor of the anti-inflammatory Th2 cytokine IL13, which is overexpressed in glioma and correlated with poor prognosis.
Chimeric antigen receptor (CAR) T cell therapy is a promising treatment approach for many malignancies. IL13Ra2-targeted CAR-T cells are under investigation in several clinical trials in primary CNS malignancies.
The investigators now designed a new structure CAR targeted IL13Ra2, and initiated a single arm, open, dose exploration clinical trial to evaluate the safety, tolerability, clinical efficacy, and pharmacokinetic characteristics of IL13Rα2 CAR-T for patients with glioma. This clinical trial will enroll 12-30 cases of patients with IL13α2-positive recurrent or refractory WHO grade 4 glioma (r/r WHO4 glioma), aiming to find the maximum tolerable dose (MTD), the recommended phase 2 dose (RP2D) and preliminary efficacy of the new structure IL13Ra2 CAR-T.
- Conditions
- Glioma
- Being tested
- IL13Rα2 CAR-T
- Keywords
- r/r WHO4 glioma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL13Rα2 CAR-TBiological
The IL13Rα2 CAR-T cells will be administered via intraventricular infusion every 2 weekly via an Ommaya reservoir.
| Study group | Role | What they receive |
|---|---|---|
| IL13Rα2 CAR-T | Experimental | Biological: IL13Rα2 CAR-T Receives: Biological: IL13Rα2 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of IL13Rα2 CAR-T
The safety of IL13Rα2 CAR-T will be assessed based on the totality of dose-limiting toxicity (DLT) and adverse event (AE) data collected during this phase.
Measured: Day 0 - Day 730
Secondary outcomes (8)
Overall Response Rate (ORR)
To evaluate the percentage of subjects who have a confirmed partial response (PR) and complete response (CR) per immunotherapy response assessment in neuro-oncology (iRANO) criteria.
Measured: Day 0 - Day 730
Duration of Response (DOR)
To evaluate the duration from the time that criteria are met for CR or PR per iRANO until disease progression or death due to any cause.
Measured: Day 0 - Day 730
Progression Free Survival (PFS)
To evaluate the time from the date of the first CAR-T infusion until disease progression per iRANO or death due to any cause.
Measured: Day 0 - Day 730
Overall Survival (OS)
To evaluate the time from the date of the first CAR-T infusion to death due to any cause.
Measured: Day 0 - Day 730
Overall Survival (OS) at 6 months (OS6)
To evaluate the percentage of survival subjects at 6 months after the first CAR-T infusion.
Measured: Day 0 - Day 180
Overall Survival (OS) at 12 months (OS12)
To evaluate the percentage of survival subjects at 12 months after the first CAR-T infusion.
Measured: Day 0 - Day 365
The levels of IL13Rα2 CAR-T cell and IL13Rα2 CAR in the CSF and peripheral blood
To detect the levels of IL13Rα2 CAR-T cell and IL13Rα2 CAR in the CSF and peripheral blood.
Measured: Day 0 - Day 730
The levels of cytokines in the CSF and peripheral blood
To detect levels of cytokines in the CSF and peripheral blood, cytokines will include IL-2, IL-6, IFN-γ, TNF-α, etc.
Measured: Day 0 - Day 730
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start21 Mar 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Why it stopped: Temporarily suspended for HGRAC filing requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- TCRCure Biopharma Ltd.
- Responsible party
- Sponsor-investigator, Yang Zhang, Beijing Tiantan Hospital
- Investigators
- Nan Ji, MD, PhD, Principal investigator, Beijing Tiantan HospitalYang Zhang, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355908
- Sponsor's protocol ID
- TT002
- Acronym
- ENHANCING
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Efficacy of Enhanced IL-13Rα2 Targeted Chimeric Antigen Receptor T Cell Immunotherapy Against Recurrent/Refractory Grade 4 Glioma
- ClinicalTrials.gov ID
- NCT06355908
- Acronym / sponsor ID
- ENHANCING / TT002
- Conditions
- Glioma
- Keywords
- r/r WHO4 glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporarily suspended for HGRAC filing requirements
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yang ZhangUniversity, hospital or other
- Collaborators
- TCRCure Biopharma Ltd.
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 10 Apr 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.
This is a dose exploration clinical trial to assess the safety and feasibility of the IL13Ra2-targeted CAR-T in glioma.
Detailed description
Interleukin 13 receptor subunit alpha-2 (IL13Ra2A) is a high-affinity membrane receptor of the anti-inflammatory Th2 cytokine IL13, which is overexpressed in glioma and correlated with poor prognosis.
Chimeric antigen receptor (CAR) T cell therapy is a promising treatment approach for many malignancies. IL13Ra2-targeted CAR-T cells are under investigation in several clinical trials in primary CNS malignancies.
The investigators now designed a new structure CAR targeted IL13Ra2, and initiated a single arm, open, dose exploration clinical trial to evaluate the safety, tolerability, clinical efficacy, and pharmacokinetic characteristics of IL13Rα2 CAR-T for patients with glioma. This clinical trial will enroll 12-30 cases of patients with IL13α2-positive recurrent or refractory WHO grade 4 glioma (r/r WHO4 glioma), aiming to find the maximum tolerable dose (MTD), the recommended phase 2 dose (RP2D) and preliminary efficacy of the new structure IL13Ra2 CAR-T.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IL13Rα2 CAR-T | Experimental | Biological: IL13Rα2 CAR-TBiological: IL13Rα2 CAR-T |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged 18-75 years (including 18 and 75 years old).
- Karnofsky scale score (KPS)≥50.
- Subjects with WHO grade 4 gliomas who have relapsed or progressed during or after standard treatments such as surgery, radiotherapy, and chemotherapy.
- Tumor with IL13Rα2 positive expression.
- Availability in collecting peripheral blood mononuclear cells (PBMCs).
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding females.
- Contraindication to bevacizumab.
- Within 5 days prior to the infusion of CAR-T cells, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids (not including inhaled corticosteroid).
- Comorbid with other uncontrolled malignancy.
- Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or tuberculosis infection.
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 |
|---|---|---|
| IL13Rα2 CAR-TThe IL13Rα2 CAR-T cells will be administered via intraventricular infusion every 2 weekly via an Ommaya reservoir. | Biological | IL13Rα2 CAR-T |
Primary outcome
Safety of IL13Rα2 CAR-T
Time frame: Day 0 - Day 730
The safety of IL13Rα2 CAR-T will be assessed based on the totality of dose-limiting toxicity (DLT) and adverse event (AE) data collected during this phase.
8 secondary outcomes
Overall Response Rate (ORR)
Time frame: Day 0 - Day 730
Duration of Response (DOR)
Time frame: Day 0 - Day 730
Progression Free Survival (PFS)
Time frame: Day 0 - Day 730
Overall Survival (OS)
Time frame: Day 0 - Day 730
Overall Survival (OS) at 6 months (OS6)
Time frame: Day 0 - Day 180
Overall Survival (OS) at 12 months (OS12)
Time frame: Day 0 - Day 365
The levels of IL13Rα2 CAR-T cell and IL13Rα2 CAR in the CSF and peripheral blood
Time frame: Day 0 - Day 730
The levels of cytokines in the CSF and peripheral blood
Time frame: Day 0 - Day 730
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Nan Ji, MD, PhD principal investigator
Beijing Tiantan Hospital
Yang Zhang principal investigator
Beijing Tiantan Hospital
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 IL13Rα2 CAR-T in people with Glioma, run by Yang Zhang 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 7 inclusion and 9 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: paused, as of the sponsor's last update on 1 Oct 2026. 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?
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?
Safety of IL13Rα2 CAR-T (time frame: Day 0 - Day 730). 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 1 Oct 2026.