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γδ T-PD-1 Ab Cells in the Treatment of Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChangzhou No.2 People's Hospital

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 advanced solid tumors.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The patient voluntarily signs the informed consent and can complete the follow-up examination, evaluation and treatment;

Age 18-80 years old, gender is not limited;

The histopathological diagnosis was malignant solid tumor;

Clinical or pathological was stage IV according to AJCC 8th edition stage;

Disqualifiers

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

Metastasis of symptomatic central system;

Have received other cell therapies, including NK, CIK, DC, CTL, CAR-T, TCR-T, and stem cell therapy in the past 4 weeks;

Received systemic steroid therapy (> 10 mg/kg prednisone or equivalent) or any other form of immunosuppressive medication within two weeks prior to the first dose; Corticosteroids (≤10mg oral prednisone or equivalent) were used in subjects with chronic obstructive pulmonary disease, saline corticosteroids (such as hydrohydrocortisone) were used in subjects with postural hypotension, and low-dose supplemental corticosteroids were used in subjects with adrenal insufficiency.

Trial design

Design model

Single group

Treatments tested in this trial

  • γδ T-PD-1 Ab cells

    Biological/Vaccine

    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.

Treatment groups

9 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
up to 60 weeks
2

Safety evaluation: Dose limited toxicity (DLTs)

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

Time frame
up to 60 weeks
3

Safety evaluation: Maximum-tolerated dose (MTD)

MTD or clinical recommended dose will be recorded and evaluated.

Time frame
up to 60 weeks

Secondary outcomes

1

Efficacy evaluation: Objective Response Rate(ORR)

Objective response rate will be assessed by investigators.

Time frame
up to 15months
2

Efficacy evaluation: Disease Control Rate (DCR)

Disease Control Rate will be assessed by investigators.

Time frame
up to 15months
3

Efficacy evaluation: Progress Free Survival(PFS)

Observation for progression-free survival (PFS) will be recorded until 15 months after the start of 1st cycle of treatment.

Time frame
up to 15months
4

Efficacy evaluation: Overall Survival (OS)

Observation for overall survival (OS) will be recorded until 15 months after the start of 1st cycle of treatment.

Time frame
up to 15months

Other outcomes

Sponsors and contacts

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

Changzhou No.2 People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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