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

Phase 1

Not yet recruiting

• Conditions: Anaplastic Throid Carcinoma
• Interventions: Drug: NKG2D CAR-NK with PD-1 Antibody

• Registration Number: NCT06856278
• Lead Sponsor: Zhejiang Provincial People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2025-02-22
• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Primary Completion: 2028-12-31
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treated with CAR-NK immune cells combined with PD-1 monoclonal antibody.	NKG2D CAR-NK with PD-1 Antibody	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	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.

Trial Locations

Locations (1)

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China