Clinical Study of NKG2D CAR-NK Combined with PD-1 Monoclonal Antibody in the Treatment of ATC

February 26, 2025 updated by: Zhejiang Provincial People's Hospital

Clinical Exploratory Study of NKG2D CAR-NK Combined with PD-1 Monoclonal Antibody in the Treatment of Anaplastic Thyroid Cancer (ATC)

The patients with anaplastic thyroid cancer were treated with CAR-NK immune cells combined with PD-1 monoclonal antibody, and the safety and tolerability of the patients were observed and evaluated.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-75 years (including boundary values), male or female.
  2. Be diagnosed with anaplastic thyroid cancer histopathologically with a measurable lesion≥1cm.
  3. Liver and kidney function is good, and can tolerate treatment.
  4. Be able to cooperate with the completion of treatment and follow-up work.
  5. No other systemic diseases, including other malignancies.

Exclusion Criteria:

  1. Need to breastfeed the baby or have fertility needs；
  2. Immune system diseases;
  3. Diseases of the blood system;
  4. Mental system diseases;
  5. Interstitial pneumonia, lung disease, etc.;
  6. Failure to follow rules of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treated with CAR-NK immune cells combined with PD-1 monoclonal antibody.
Drug: NKG2D CAR-NK with PD-1 Antibody
Treated with CAR-NK immune cells combined with PD-1 monoclonal antibody.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: From the start of the trial to day 56 after the first infusion of CAR-NK.
Safety and tolerability at 28 days after combination therapy, dose limiting toxicity (DLT) and maximum tolerated dose (MTD) were determined.
From the start of the trial to day 56 after the first infusion of CAR-NK.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 22, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAR-NK GeT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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