Malignant MeningiomaEarly Phase 1NCT07172178
γδ T-PD-1 Ab Cells in the Treatment of Malignant Meningioma
A Early Phase 1 study testing γδ T-PD-1 Ab cells in people with Malignant Meningioma, run by Nanjing Medical University.
Trial summary
This study intends to combine the advantages of γδ T cells and PD-1 monoclonal antibody to conduct an exploratory clinical study on the safety and efficacy of PD-1 antibody armored γδ T cells (γδ T-PD-1 Ab cells) in the treatment of malignant meningioma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Meningioma
- What is being tested?
- γδ T-PD-1 Ab cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to Oct 2029
- Phase
- Early 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient voluntarily signs the informed consent and can complete the follow-up examination, evaluation and treatment;
- Age 18-70 years old (both ends included), both male and female;
- The histopathological diagnosis was malignant solid tumor;
- Tumor recurrence is confirmed by imaging (MRI) or re-biopsy/surgery;
- ECOG score 0-2;
- Expected survival ≥6 months;
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- Have received chemotherapy or targeted therapy more than 4 weeks ago;
- Organ function requirements:
- Bone marrow function: white blood cell count≥3×109, platelets ≥70×109/L, a hemoglobin (Hb) ≥90g/L; Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN; Renal function: serum creatinine level ≤1.5 ULN; Coagulation function: international normalized ratio (INR) does not exceed 1.5 times the upper limit of normal, and activated partial thromboplastin time (APTT) does not exceed 1.5 times the upper limit of normal.
- Cardiac function: left ventricular ejection fraction (LVEF) > 55%
- Pregnant women of childbearing age must have a negative serum pregnancy test within 28 days before treatment. Any fertile male and female patients must agree to use effective contraceptive methods throughout the study and for at least 12 weeks after the last study administration.
Who cannot join
- Intolerance or allergy to any ingredient or similar drug in the treatment plan planned for this study;
- Major organ dysfunction:
- Cardiac function: Left ventricular ejection fraction (LVEF) ≤ 55%, New York Heart Association (NYHA) grade III or IV congestive heart failure, QTc > 480 msec, other cardiac diseases as determined by the investigator to be unsuitable for inclusion.
- Liver function: Child-Pugh liver function classification C or above. Pulmonary function: Severe respiratory failure affecting other organs.
- Uncontrolled epilepsy, severe bleeding risk (such as a recent history of cerebral hemorrhage).
- Active and/or uncontrolled infections (such as tuberculosis, sepsis, opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) infection, Treponema pallidum (TP) infection).
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- Severe, uncontrolled systemic autoimmune or inflammatory diseases (such as systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis, Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)).
- Unstable systemic diseases: unstable angina pectoris, cerebrovascular accident or transient ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), grade III or IV cardiac dysfunction, refractory hypertension (refractory hypertension is defined as: after lifestyle improvement and using appropriate doses of ≥ 4 antihypertensive drugs (including diuretics), blood pressure cannot be effectively controlled after treatment for more than 1 month and still not controlled), severe arrhythmia requiring drug treatment, hepatic arrhythmia, liver disease, kidney disease or metabolic disorders.
- Patients with other malignant tumors.
- Major surgeries within 4 weeks before screening that were assessed by the investigator as unsuitable for inclusion.
- Participated in other interventional clinical studies within 30 days before enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Anti-PD-1 Antibody Armored γδ T Cells in the Treatment of Malignant Meningioma, a Phase I Clinical Trail
This study intends to combine the advantages of γδ T cells and PD-1 monoclonal antibody to conduct an exploratory clinical study on the safety and efficacy of PD-1 antibody armored γδ T cells (γδ T-PD-1 Ab cells) in the treatment of malignant meningioma.
Read the detailed description
This is a single-center, single-arm, phase I clinical trial to evaluate the safety and efficacy of γδ T-PD-1 Ab cells in patients with malignant meningioma. A typical 3+3 dose-escalation design will be used to determine the optimal dose level of γδ T-PD-1 Ab cells based on the incidence of dose-limiting toxicity (DLT). The initial injection dose level will start from 1×10^7 to 1×10^8 in every 2 weeks.
- Conditions
- Malignant Meningioma
- Being tested
- γδ T-PD-1 Ab cells
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
γδ T-PD-1 Ab cellsBiological
Patients will receive 6 cycles of ex-vivo expanded γδ T-PD-1 Ab cells treatments,at two-weeks' intervals.γδ T-PD-1 Ab cells are injected through the Ommaya device in a typical 3+3 dose-escalation design(Dose escalation, 1×10^7, 3×10^7, 1×10^8).
| Study group | Role | What they receive |
|---|---|---|
| γδ T-PD-1 Ab cells | Experimental | o Cells will be extracted from a healthy donor, followed by ex-vivo expansion, activation and genetic engineering. The ex-vivo expanded γδ T-PD-1 Ab cells will be adoptively transfused to tumor patients. Receives: Biological: γδ T-PD-1 Ab cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation: Incidence of Adverse events (AEs)
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Measured: 96 weeks
Safety evaluation: Dose limited toxicity (DLTs)
The incidence, characteristic and severity of DLTs will be recorded and assessed.
Measured: 96 weeks
Safety evaluation: Maximum-tolerated dose (MTD)
MTD or clinical recommended dose will be recorded and evaluated.
Measured: 96 weeks
Secondary outcomes (4)
Efficacy evaluation: Objective Response Rate(ORR)
Objective response rate will be assessed by investigators.
Measured: 12 weeks
Efficacy evaluation: Disease Control Rate (DCR)
Disease Control Rate will be assessed by investigators.
Measured: 12 weeks
Efficacy evaluation: Progress Free Survival(PFS)
Observation for progression-free survival (PFS) will be recorded until 6 months after the start of 1st cycle of treatment.
Measured: 12 weeks
Efficacy evaluation: Two-year Overall Survival Rate (OS)
Observation for overall survival (OS) will be recorded until 24months after the start of 1st cycle of treatment.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MeningiomaStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Liu, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172178
- Sponsor's protocol ID
- GDT-003-02
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-PD-1 Antibody Armored γδ T Cells in the Treatment of Malignant Meningioma, a Phase I Clinical Trail
- ClinicalTrials.gov ID
- NCT07172178
- Acronym / sponsor ID
- GDT-003-02
- Conditions
- Malignant Meningioma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 15 Sep 2025 (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 study intends to combine the advantages of γδ T cells and PD-1 monoclonal antibody to conduct an exploratory clinical study on the safety and efficacy of PD-1 antibody armored γδ T cells (γδ T-PD-1 Ab cells) in the treatment of malignant meningioma.
Detailed description
This is a single-center, single-arm, phase I clinical trial to evaluate the safety and efficacy of γδ T-PD-1 Ab cells in patients with malignant meningioma. A typical 3+3 dose-escalation design will be used to determine the optimal dose level of γδ T-PD-1 Ab cells based on the incidence of dose-limiting toxicity (DLT). The initial injection dose level will start from 1×10^7 to 1×10^8 in every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| γδ T-PD-1 Ab cells | Experimental | Biological: γδ T-PD-1 Ab cellso Cells will be extracted from a healthy donor, followed by ex-vivo expansion, activation and genetic engineering. The ex-vivo expanded γδ T-PD-1 Ab cells will be adoptively transfused to tumor patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patient voluntarily signs the informed consent and can complete the follow-up examination, evaluation and treatment;
- Age 18-70 years old (both ends included), both male and female;
- The histopathological diagnosis was malignant solid tumor;
- Tumor recurrence is confirmed by imaging (MRI) or re-biopsy/surgery;
- ECOG score 0-2;
Key exclusion criteria (11 listed)
- Intolerance or allergy to any ingredient or similar drug in the treatment plan planned for this study;
- Major organ dysfunction:
- Cardiac function: Left ventricular ejection fraction (LVEF) ≤ 55%, New York Heart Association (NYHA) grade III or IV congestive heart failure, QTc > 480 msec, other cardiac diseases as determined by the investigator to be unsuitable for inclusion.
- Liver function: Child-Pugh liver function classification C or above. Pulmonary function: Severe respiratory failure affecting other organs.
- Uncontrolled epilepsy, severe bleeding risk (such as a recent history of cerebral hemorrhage).
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 |
|---|---|---|
| γδ T-PD-1 Ab cellsPatients will receive 6 cycles of ex-vivo expanded γδ T-PD-1 Ab cells treatments,at two-weeks' intervals.γδ T-PD-1 Ab cells are injected through the Ommaya device in a typical 3+3 dose-escalation design(Dose escalation, 1×10^7, 3×10^7, 1×10^8). | Biological | γδ T-PD-1 Ab cells |
Primary outcome
Safety evaluation: Incidence of Adverse events (AEs)
Time frame: 96 weeks
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Safety evaluation: Dose limited toxicity (DLTs)
Time frame: 96 weeks
The incidence, characteristic and severity of DLTs will be recorded and assessed.
Safety evaluation: Maximum-tolerated dose (MTD)
Time frame: 96 weeks
MTD or clinical recommended dose will be recorded and evaluated.
4 secondary outcomes
Efficacy evaluation: Objective Response Rate(ORR)
Time frame: 12 weeks
Efficacy evaluation: Disease Control Rate (DCR)
Time frame: 12 weeks
Efficacy evaluation: Progress Free Survival(PFS)
Time frame: 12 weeks
Efficacy evaluation: Two-year Overall Survival Rate (OS)
Time frame: 96 weeks
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 15 Sep 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing γδ T-PD-1 Ab cells in people with Malignant Meningioma, run by Nanjing Medical University.
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 11 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: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Fang Liu, MD (+86-8068562999, czdoctorliu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation: Incidence of Adverse events (AEs) (time frame: 96 weeks). The study lists 3 primary outcomes in all. 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 15 Sep 2025.