Not Yet RecruitingEarly Phase 1

γδ T-PD-1 Ab Cells in the Treatment of Malignant Meningioma

12 participantsStarted 2025-10-15

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. Have received chemotherapy or targeted therapy more than 4 weeks ago;
✓. Organ function requirements:

Exclusion criteria

✕. Intolerance or allergy to any ingredient or similar drug in the treatment plan planned for this study;
✕. Major organ dysfunction:
✕. 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).
✕. 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.

What they're measuring

Safety evaluation: Incidence of Adverse events (AEs)

Timeframe: 96 weeks

Safety evaluation: Dose limited toxicity (DLTs)

Timeframe: 96 weeks

Safety evaluation: Maximum-tolerated dose (MTD)

Timeframe: 96 weeks

Trial details

NCT IDNCT07172178

SponsorNanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10

Contact for this trial

Fang Liu, MD

+86-8068562999 czdoctorliu@hotmail.com

View on ClinicalTrials.gov More Malignant Meningioma trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. Have received chemotherapy or targeted therapy more than 4 weeks ago;
✓. Organ function requirements:

Exclusion criteria

✕. Intolerance or allergy to any ingredient or similar drug in the treatment plan planned for this study;
✕. Major organ dysfunction:
✕. 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).
✕. 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.