Status:
RECRUITING
Clinical Study of GT201 in Combination with PD-1 Inhibitor for Advanced Head and Neck Tumors
Lead Sponsor:
Grit Biotechnology
Conditions:
Adults
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study is a single-arm early exploratory clinical study. designed to evaluate the safety and tolerability of GT201 in combination with a PD-1 inhibitor for the treatment of advanced head and neck ...
Detailed Description
Primary objectives a. To assess the safety and tolerability of GT201 in combination with PD-1 inhibitor in the treatment of advanced head and neck tumors. Secondary Objectives 1. To assess the effi...
Eligibility Criteria
Inclusion
- 1\. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;
- 2\. Age 18 to 70 years old;
- 3\. Diagnosis with recurrent or metastatic head and neck malignant tumors and received≤2 lines of systemic therapy;
- 4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- 5\. Expected survival time of ≥ 12 weeks;
- 6\. Good function of vital organs;
- 7\. Subjects who enter this study due to poor treatment efficacy or intolerance must have medical records describing their condition after previous treatment or imaging records of lesion evaluation before tumor sampling;
- 8\. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.
Exclusion
- Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
- Known mental illness, alcoholism, drug use or substance abuse;
- Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
- Those who have received other clinical trial drug treatment within 4 weeks before NMA-LD chemotherapy or plan to participate in other clinical trial drug treatment during the study;
- The investigators determine that other conditions that make the patient not suitable for enrollment.
Key Trial Info
Start Date :
May 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06190275
Start Date
May 12 2024
End Date
April 30 2027
Last Update
February 17 2025
Active Locations (1)
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1
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China, 200000