Recurrent Malignant GliomaPhase 1APIC-RGNCT07481721

IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody for Recurrent Malignant Glioma

A Phase 1 study testing IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody in people with Recurrent Malignant Glioma, run by Ming Yang at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Malignant Glioma
What is being tested?: IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 1 May 2026to 31 Dec 2027
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

Recurrent malignant glioma (WHO grade IV)
Pathologically confirmed and imaging-defined recurrent glioma
ECOG score of 0-2
Age >=18 years
Male or female
Life expectancy >3 months

Who cannot join

Severe immune suppression or autoimmune diseases
Severe cardiac, liver, kidney, or other major organ dysfunction
Pregnant or breastfeeding women
Prior treatment with immune checkpoint inhibitors or other immunotherapies
Other conditions posing significant risk to the patient or preventing adherence to the study protocol

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ming Yang, Medical Doctor contact

+86 138 1065 5237

yangming@cicams.ac.cn

China1 site

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Hongliang Mao, Medical Doctor, +86 18756909374, Mao.HL@hotmail.com

Other trials in China

About this study

Official title: A Multicenter, Open-Label, Non-Randomized, Single-Arm Investigator-Initiated Trial to Evaluate the Safety and Efficacy of IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody in Patients With Recurrent Malignant Glioma

This clinical study is designed to evaluate the safety and efficacy of IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody in patients with recurrent malignant glioma. This trial is a multicenter, open-label, non-randomized, single-arm investigator-initiated trial (IIT). Patients who have recurrent malignant glioma will receive IL13Rα2 CAR-T cell therapy and will be monitored for safety, adverse events (AEs), and efficacy outcomes, including overall survival (OS) and progression-free survival (PFS). The study will help assess the potential of this innovative therapy in the treatment of glioma and its ability to control tumor growth by targeting both IL13Rα2 and PD-L1.

Read the detailed description

The primary aim of this study is to evaluate the safety and efficacy of IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody for the treatment of recurrent malignant glioma. Malignant gliomas are aggressive brain tumors with limited treatment options and poor prognosis. Immunotherapy, including CAR-T cells, has shown promise in various cancers, but its application in glioma treatment remains under investigation.

This study will involve patients with recurrent glioma who have failed prior treatments. Participants will receive a single infusion of IL13Rα2 CAR-T cells, which are engineered to recognize and target tumor cells expressing IL13Rα2. The CAR-T cells will be combined with the secretion of anti-PD-L1 antibodies, aimed at overcoming the immune checkpoint inhibition in the tumor microenvironment.

Safety will be assessed by monitoring adverse events (AEs) and cytokine release syndrome (CRS). The efficacy will be evaluated by measuring tumor response, progression-free survival (PFS), and overall survival (OS) over a follow-up period of several months. The study will also assess changes in the immune microenvironment, including immune cell infiltration and expression of immune checkpoint markers.

The trial will be conducted across multiple centers, including major hospitals in China. It aims to provide valuable data on the potential of this dual-target CAR-T therapy in treating gliomas and to assess its feasibility as a clinical treatment option.

Conditions: Recurrent Malignant Glioma
Being tested: IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody
Keywords: IL13Rα2 CAR-T, PD-L1-secreting CAR-T, Recurrent Malignant Glioma, Cell Therapy, Immunotherapy
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-T Cells Secreting Anti-PD-L1 AntibodyBiological
Autologous IL13Rα2-targeted CAR-T cells engineered to secrete anti-PD-L1 antibody will be administered after lymphodepleting pretreatment. The study includes peripheral intravenous infusion alone or peripheral intravenous infusion combined with intraventricular injection. Peripheral dose-escalation levels are 1×10^6 cells/kg, 3×10^6 cells/kg, and 1×10^7 cells/kg. In the combined administration strategy, the intraventricular dose is 20%-30% of the peripheral dose, with adjustment based on patient tolerability. Patients will be monitored in the ICU or a dedicated inpatient setting during infusion and for adverse events including CRS and ICANS after infusion.

Study groups in NCT07481721
Study group	Role	What they receive
Single Treatment Arm	Experimental	Participants with recurrent malignant glioma will receive IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody within a single-arm, open-label study framework. Two administration strategies are planned according to investigator assessment and protocol procedures: peripheral intravenous infusion alone, or peripheral intravenous infusion combined with intraventricular injection. Dose escalation is planned, including 1×10^6 cells/kg, 3×10^6 cells/kg, and 1×10^7 cells/kg for peripheral infusion. For the combined administration strategy, the intraventricular dose is 20%-30% of the peripheral dose, adjusted according to tolerability. Receives: Biological: IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody

What is being measured

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

Incidence of Grade 3 or Higher Treatment-Related Adverse Events
Incidence of Grade 3 or higher treatment-related adverse events after infusion of IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody, including serious adverse events. Adverse event severity will be graded according to CTCAE version 5.0.
Measured: From first CAR-T cell infusion through Day 28
Progression-Free Survival
Progression-free survival, defined as the time from first CAR-T cell infusion to documented disease progression or death from any cause, whichever occurs first.
Measured: Up to 2 years after first CAR-T cell infusion

Secondary outcomes (10)

Incidence and Maximum Grade of Cytokine Release Syndrome
Incidence and maximum grade of cytokine release syndrome following CAR-T cell infusion, graded according to ASTCT consensus criteria.
Measured: From first CAR-T cell infusion through Day 28
Incidence and Maximum Grade of Immune Effector Cell-Associated Neurotoxicity Syndrome
Incidence and maximum grade of immune effector cell-associated neurotoxicity syndrome following CAR-T cell infusion, graded according to ASTCT consensus criteria.
Measured: From first CAR-T cell infusion through Day 28
Overall Survival
Overall survival, defined as the time from first CAR-T cell infusion to death from any cause.
Measured: Up to 2 years after first CAR-T cell infusion
Objective Response Rate by MRI/PET-CT
Objective response rate, defined as the proportion of participants achieving complete response or partial response based on imaging assessment using multimodal MRI and/or PET-CT.
Measured: Assessed at Day 56, Day 84, and every 3 months thereafter up to 2 years
Change in Tumor Volume on Imaging
Change in tumor volume from baseline measured by multimodal MRI and/or PET-CT.
Measured: Baseline, Day 7, Day 28, Day 56, Day 84, and every 3 months thereafter up to 2 years
Change in Quality of Life Score Measured by EORTC QLQ-C30
Change from baseline in quality of life as assessed by the EORTC QLQ-C30 questionnaire.
Measured: Baseline, Day 28, Day 56, Day 84, and every 3 months thereafter up to 2 years
Change in Karnofsky Performance Status Score
Change from baseline in Karnofsky Performance Status score.
Measured: Baseline, Day 28, Day 56, Day 84, and every 3 months thereafter up to 2 years
Change in Modified Rankin Scale Score
Change from baseline in modified Rankin Scale score.
Measured: Baseline, Day 28, Day 56, Day 84, and every 3 months thereafter up to 2 years
Persistence of CAR-T Cells in Peripheral Blood
Persistence of IL13Rα2 CAR-T cells in peripheral blood measured by flow cytometry and/or real-time PCR.
Measured: Baseline and multiple post-infusion time points through 2 years
Persistence of CAR-T Cells in Cerebrospinal Fluid
Persistence of IL13Rα2 CAR-T cells in cerebrospinal fluid, when available, is measured by flow cytometry and/or real-time PCR.
Measured: Post-infusion time points through 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202631 Dec 2027

First posted19 Mar 2026
Study start1 May 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Recurrent Malignant 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
Model description: This is a multicenter, open-label, non-randomized, single-arm investigator-initiated trial. Eligible patients with recurrent malignant glioma will receive IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody. Two administration strategies are planned within the single-group study framework: peripheral intravenous infusion alone, or peripheral intravenous infusion combined with intraventricular injection, with dose-escalation and safety monitoring.
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07481721
Sponsor's protocol ID: NCC5972
Other IDs: 2024-I2M-3-014
Acronym: APIC-RG
Status last verified: Mar 2026
First submitted: 9 Mar 2026
Last updated: 19 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: At this stage, we have not made definitive plans to share individual participant data (IPD). However, data will be made available to qualified researchers upon request after the completion of the study and publication of the results, subject to applicable privacy and ethical guidelines.

Publications

Li X, Shang X, Liu J, Zhang Y, Jia X, Li H, Wang Y, Gao J, Ma X, Zhang X, Rong X, Gan W, Zhang Y, Chen J, Wang L, Bao Z, He L, Yan X, Liu Y, Shao J, Xiao Z, Wang Z, Zhu H, Wang Z, Wu Y, Huang Y. Intrathecal CRISPR-edited allogeneic IL-13Ralpha2 CAR T Cells for recurrent high-grade Glioma: preclinical characterization and phase I trial. Nat Commun. 2026 Jan 6;17(1):1362. doi: 10.1038/s41467-025-68112-6.
PubMed 41495049
Law I, Albert NL, Arbizu J, Boellaard R, Drzezga A, Galldiks N, la Fougere C, Langen KJ, Lopci E, Lowe V, McConathy J, Quick HH, Sattler B, Schuster DM, Tonn JC, Weller M. Joint EANM/EANO/RANO practice guidelines/SNMMI procedure standards for imaging of gliomas using PET with radiolabelled amino acids and [18F]FDG: version 1.0. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):540-557. doi: 10.1007/s00259-018-4207-9. Epub 2018 Dec 5.
PubMed 30519867
Long AH, Haso WM, Shern JF, Wanhainen KM, Murgai M, Ingaramo M, Smith JP, Walker AJ, Kohler ME, Venkateshwara VR, Kaplan RN, Patterson GH, Fry TJ, Orentas RJ, Mackall CL. 4-1BB costimulation ameliorates T cell exhaustion induced by tonic signaling of chimeric antigen receptors. Nat Med. 2015 Jun;21(6):581-90. doi: 10.1038/nm.3838. Epub 2015 May 4.
PubMed 25939063
Portnow J, Wang D, Blanchard MS, Tran V, Alizadeh D, Starr R, Dodia R, Chiu V, Brito A, Kilpatrick J, McNamara P, Forman SJ, Badie B, Synold TW, Brown CE. Systemic Anti-PD-1 Immunotherapy Results in PD-1 Blockade on T Cells in the Cerebrospinal Fluid. JAMA Oncol. 2020 Dec 1;6(12):1947-1951. doi: 10.1001/jamaoncol.2020.4508.
PubMed 33030521

Interested in taking part?

Ming Yang, Medical Doctor

+86 138 1065 5237

yangming@cicams.ac.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label, Non-Randomized, Single-Arm Investigator-Initiated Trial to Evaluate the Safety and Efficacy of IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody in Patients With Recurrent Malignant Glioma
ClinicalTrials.gov ID: NCT07481721
Acronym / sponsor ID: APIC-RG / NCC5972
Conditions: Recurrent Malignant Glioma
Keywords: IL13Rα2 CAR-T, PD-L1-secreting CAR-T, Recurrent Malignant Glioma, Cell Therapy, Immunotherapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: Ming YangUniversity, hospital or other
Collaborators: Peking Union Medical College Hospital, Emergency General Hospital, Department of Neurosurgery, Peking University International Hospital
Study start: 1 May 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 19 Mar 2026 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a multicenter, open-label, non-randomized, single-arm investigator-initiated trial. Eligible patients with recurrent malignant glioma will receive IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody. Two administration strategies are planned within the single-group study framework: peripheral intravenous infusion alone, or peripheral intravenous infusion combined with intraventricular injection, with dose-escalation and safety monitoring.

Arm	Type	Receives
Single Treatment Arm	Experimental	Biological: IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 AntibodyParticipants with recurrent malignant glioma will receive IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody within a single-arm, open-label study framework. Two administration strategies are planned according to investigator assessment and protocol procedures: peripheral intravenous infusion alone, or peripheral intravenous infusion combined with intraventricular injection. Dose escalation is planned, including 1×10^6 cells/kg, 3×10^6 cells/kg, and 1×10^7 cells/kg for peripheral infusion. For the combined administration strategy, the intraventricular dose is 20%-30% of the peripheral dose, adjusted according to tolerability.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Recurrent malignant glioma (WHO grade IV)
Pathologically confirmed and imaging-defined recurrent glioma
ECOG score of 0-2
Age >=18 years
Male or female

Key exclusion criteria (5 listed)

Severe immune suppression or autoimmune diseases
Severe cardiac, liver, kidney, or other major organ dysfunction
Pregnant or breastfeeding women
Prior treatment with immune checkpoint inhibitors or other immunotherapies
Other conditions posing significant risk to the patient or preventing adherence to the study protocol

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-T Cells Secreting Anti-PD-L1 AntibodyAutologous IL13Rα2-targeted CAR-T cells engineered to secrete anti-PD-L1 antibody will be administered after lymphodepleting pretreatment. The study includes peripheral intravenous infusion alone or peripheral intravenous infusion combined with intraventricular injection. Peripheral dose-escalation levels are 1×10^6 cells/kg, 3×10^6 cells/kg, and 1×10^7 cells/kg. In the combined administration strategy, the intraventricular dose is 20%-30% of the peripheral dose, with adjustment based on patient tolerability. Patients will be monitored in the ICU or a dedicated inpatient setting during infusion and for adverse events including CRS and ICANS after infusion.	Biological	Single Treatment Arm

Primary outcome

Incidence of Grade 3 or Higher Treatment-Related Adverse Events
Time frame: From first CAR-T cell infusion through Day 28
Incidence of Grade 3 or higher treatment-related adverse events after infusion of IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody, including serious adverse events. Adverse event severity will be graded according to CTCAE version 5.0.
Progression-Free Survival
Time frame: Up to 2 years after first CAR-T cell infusion
Progression-free survival, defined as the time from first CAR-T cell infusion to documented disease progression or death from any cause, whichever occurs first.

10 secondary outcomes

Incidence and Maximum Grade of Cytokine Release Syndrome
Time frame: From first CAR-T cell infusion through Day 28
Incidence and Maximum Grade of Immune Effector Cell-Associated Neurotoxicity Syndrome
Time frame: From first CAR-T cell infusion through Day 28
Overall Survival
Time frame: Up to 2 years after first CAR-T cell infusion
Objective Response Rate by MRI/PET-CT
Time frame: Assessed at Day 56, Day 84, and every 3 months thereafter up to 2 years
Change in Tumor Volume on Imaging
Time frame: Baseline, Day 7, Day 28, Day 56, Day 84, and every 3 months thereafter up to 2 years
Change in Quality of Life Score Measured by EORTC QLQ-C30
Time frame: Baseline, Day 28, Day 56, Day 84, and every 3 months thereafter up to 2 years
Change in Karnofsky Performance Status Score
Time frame: Baseline, Day 28, Day 56, Day 84, and every 3 months thereafter up to 2 years
Change in Modified Rankin Scale Score
Time frame: Baseline, Day 28, Day 56, Day 84, and every 3 months thereafter up to 2 years
Persistence of CAR-T Cells in Peripheral Blood
Time frame: Baseline and multiple post-infusion time points through 2 years
Persistence of CAR-T Cells in Cerebrospinal Fluid
Time frame: Post-infusion time points through 2 years

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 19 Mar 2026.
Background: PubMed 41495049Li X, Shang X, Liu J, Zhang Y, Jia X, Li H, Wang Y, Gao J, Ma X, Zhang X, Rong X, Gan W, Zhang Y, Chen J, Wang L, Bao Z, He L, Yan X, Liu Y, Shao J, Xiao Z, Wang Z, Zhu H, Wang Z, Wu Y, Huang Y. Intrathecal CRISPR-edited allogeneic IL-13Ralpha2 CAR T Cells for recurrent high-grade Glioma: preclinical characterization and phase I trial. Nat Commun. 2026 Jan 6;17(1):1362. doi: 10.1038/s41467-025-68112-6.
Background: PubMed 30519867Law I, Albert NL, Arbizu J, Boellaard R, Drzezga A, Galldiks N, la Fougere C, Langen KJ, Lopci E, Lowe V, McConathy J, Quick HH, Sattler B, Schuster DM, Tonn JC, Weller M. Joint EANM/EANO/RANO practice guidelines/SNMMI procedure standards for imaging of gliomas using PET with radiolabelled amino acids and [18F]FDG: version 1.0. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):540-557. doi: 10.1007/s00259-018-4207-9. Epub 2018 Dec 5.
Background: PubMed 25939063Long AH, Haso WM, Shern JF, Wanhainen KM, Murgai M, Ingaramo M, Smith JP, Walker AJ, Kohler ME, Venkateshwara VR, Kaplan RN, Patterson GH, Fry TJ, Orentas RJ, Mackall CL. 4-1BB costimulation ameliorates T cell exhaustion induced by tonic signaling of chimeric antigen receptors. Nat Med. 2015 Jun;21(6):581-90. doi: 10.1038/nm.3838. Epub 2015 May 4.
Background: PubMed 33030521Portnow J, Wang D, Blanchard MS, Tran V, Alizadeh D, Starr R, Dodia R, Chiu V, Brito A, Kilpatrick J, McNamara P, Forman SJ, Badie B, Synold TW, Brown CE. Systemic Anti-PD-1 Immunotherapy Results in PD-1 Blockade on T Cells in the Cerebrospinal Fluid. JAMA Oncol. 2020 Dec 1;6(12):1947-1951. doi: 10.1001/jamaoncol.2020.4508.
Individual participant dataSharing planned: Undecided. At this stage, we have not made definitive plans to share individual participant data (IPD). However, data will be made available to qualified researchers upon request after the completion of the study and publication of the results, subject to applicable privacy and ethical guidelines.

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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.

Ming Yang, Medical Doctor contact

+86 138 1065 5237

yangming@cicams.ac.cn

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 Cells Secreting Anti-PD-L1 Antibody in people with Recurrent Malignant Glioma, run by Ming Yang 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 5 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: opening soon, as of the sponsor's last update on 19 Mar 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?

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?

Contact Ming Yang, Medical Doctor (+86 138 1065 5237, yangming@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Grade 3 or Higher Treatment-Related Adverse Events (time frame: From first CAR-T cell infusion through Day 28). 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?

On the ClinicalTrials.gov record for NCT07481721, which also lists 4 linked publications.

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 Mar 2026.