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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. The patient voluntarily signs the informed consent and can complete the follow-up examination, evaluation and treatment; 2. Age 18-70 years old (both ends included), both male and female; 3. The histopathological diagnosis was malignant solid tumor; 4. Tumor recurrence is confirmed by imaging (MRI) or re-biopsy/surgery; 5. ECOG score 0-2; 6. Expected survival ≥6 months; 7. Have received chemotherapy or targeted therapy more than 4 weeks ago; 8. 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% 9. 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.

Exclusion Criteria:

1. Intolerance or allergy to any ingredient or similar drug in the treatment plan planned for this study; 2. 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. 3. Uncontrolled epilepsy, severe bleeding risk (such as a recent history of cerebral hemorrhage). 4. 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). 5. 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)). 6. 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. 7. Patients with other malignant tumors. 8. Major surgeries within 4 weeks before screening that were assessed by the investigator as unsuitable for inclusion. 9. Participated in other interventional clinical studies within 30 days before enrollment.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07172178
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Nanjing Medical University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Meningioma

Additional Details

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.

Arms & Interventions

Arms

Experimental: γδ T-PD-1 Ab cells

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.

Interventions

Biological: - γδ T-PD-1 Ab cells

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).