Anaplastic Throid CarcinomaPhase 1/2NCT06856278
Clinical Study of NKG2D CAR-NK Combined with PD-1 Monoclonal Antibody in the Treatment of ATC
A Phase 1/2 study testing NKG2D CAR-NK with PD-1 Antibody in people with Anaplastic Throid Carcinoma, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anaplastic Throid Carcinoma
- What is being tested?
- NKG2D CAR-NK with PD-1 Antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2025to 1 Mar 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years (including boundary values), male or female.
- Be diagnosed with anaplastic thyroid cancer histopathologically with a measurable lesion≥1cm.
- Liver and kidney function is good, and can tolerate treatment.
- Be able to cooperate with the completion of treatment and follow-up work.
- No other systemic diseases, including other malignancies.
Who cannot join
- Need to breastfeed the baby or have fertility needs；
- Immune system diseases;
- Diseases of the blood system;
- Mental system diseases;
- Interstitial pneumonia, lung disease, etc.;
- Failure to follow rules of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Anaplastic Throid Carcinoma
- Being tested
- NKG2D CAR-NK with PD-1 Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKG2D CAR-NK with PD-1 AntibodyDrug
Treated with CAR-NK immune cells combined with PD-1 monoclonal antibody.
| Study group | Role | What they receive |
|---|---|---|
| treated with CAR-NK immune cells combined with PD-1 monoclonal antibody. | Experimental | Not described Receives: Drug: NKG2D CAR-NK with PD-1 Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Safety and tolerability at 28 days after combination therapy, dose limiting toxicity (DLT) and maximum tolerated dose (MTD) were determined.
Measured: From the start of the trial to day 56 after the first infusion of CAR-NK.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start22 Feb 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Throid CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856278
- Sponsor's protocol ID
- CAR-NK GeT
- Status last verified
- Sep 2024
- First submitted
- 26 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Exploratory Study of NKG2D CAR-NK Combined with PD-1 Monoclonal Antibody in the Treatment of Anaplastic Thyroid Cancer (ATC)
- ClinicalTrials.gov ID
- NCT06856278
- Acronym / sponsor ID
- CAR-NK GeT
- Conditions
- Anaplastic Throid Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 22 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treated with CAR-NK immune cells combined with PD-1 monoclonal antibody. | Experimental | Drug: NKG2D CAR-NK with PD-1 Antibody |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years (including boundary values), male or female.
- Be diagnosed with anaplastic thyroid cancer histopathologically with a measurable lesion≥1cm.
- Liver and kidney function is good, and can tolerate treatment.
- Be able to cooperate with the completion of treatment and follow-up work.
- No other systemic diseases, including other malignancies.
Key exclusion criteria (6 listed)
- Need to breastfeed the baby or have fertility needs；
- Immune system diseases;
- Diseases of the blood system;
- Mental system diseases;
- Interstitial pneumonia, lung disease, etc.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NKG2D CAR-NK with PD-1 AntibodyTreated with CAR-NK immune cells combined with PD-1 monoclonal antibody. | Drug | treated with CAR-NK immune cells combined with PD-1 monoclonal antibody. |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NKG2D CAR-NK with PD-1 Antibody in people with Anaplastic Throid Carcinoma, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minghua Ge (+86-0571 87666666, geminghua@hmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: From the start of the trial to day 56 after the first infusion of CAR-NK.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.