Health TrialsbyHealthPanel

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

ConditionMalignant Meningioma
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Intolerance or allergy to any ingredient or similar drug in the treatment plan planned for this study;

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)).

Trial design

Design model

Single group

Treatments tested in this trial

  • γδ T-PD-1 Ab cells

    Biological/Vaccine

    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).

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: γδ T-PD-1 Ab cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
96 weeks
2

Safety evaluation: Dose limited toxicity (DLTs)

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

Time frame
96 weeks
3

Safety evaluation: Maximum-tolerated dose (MTD)

MTD or clinical recommended dose will be recorded and evaluated.

Time frame
96 weeks

Secondary outcomes

1

Efficacy evaluation: Objective Response Rate(ORR)

Objective response rate will be assessed by investigators.

Time frame
12 weeks
2

Efficacy evaluation: Disease Control Rate (DCR)

Disease Control Rate will be assessed by investigators.

Time frame
12 weeks
3

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.

Time frame
12 weeks
4

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.

Time frame
96 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: