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

NCT07172178 | Not Yet Recruiting Early Phase 1

• 1 other identifier: GDT-003-02
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Malignant Meningioma

Outcome Measures

Primary Outcomes (3)

• 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).

  96 weeks

• Safety evaluation: Dose limited toxicity (DLTs)

  The incidence, characteristic and severity of DLTs will be recorded and assessed.

  96 weeks

• Safety evaluation: Maximum-tolerated dose (MTD)

  MTD or clinical recommended dose will be recorded and evaluated.

  96 weeks

Secondary Outcomes (4)

• Efficacy evaluation: Objective Response Rate(ORR)

  12 weeks

• Efficacy evaluation: Disease Control Rate (DCR)

  12 weeks

• Efficacy evaluation: Progress Free Survival(PFS)

  12 weeks

• Efficacy evaluation: Two-year Overall Survival Rate (OS)

  96 weeks

Study Arms (1)

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.

Biological: γδ T-PD-1 Ab cells

Interventions

γδ T-PD-1 Ab cells BIOLOGICAL

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).

γδ T-PD-1 Ab cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• Intolerance or allergy to any ingredient or similar drug in the treatment plan planned for this study;
• Major organ dysfunction:
• 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).
• 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.
• Participated in other interventional clinical studies within 30 days before enrollment.

Sponsors & Collaborators

• Nanjing Medical University: lead

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Central Study Contacts

Fang Liu, MD

CONTACT

+86-8068562999; czdoctorliu@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 15, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share