Clinical trial NCT06190275: Clinical Study of GT201 in Combination with PD-1 Inhibitor for Advanced Head and Neck Tumors
Official title: A Single-Arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Infusion (GT201) in Combination with PD-1 Inhibitor for Advanced Head and Neck Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adults
Lead sponsor: Grit Biotechnology
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 tumor subjects with safety and tolerability, as well as pharmacokinetic characterization and efficacy The study consists of two phases.

The study consists of two phases, a dose-escalation phase and a dose-expansion phase.

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 efficacy of GT201 in combination with PD-1 inhibitors in the treatment of advanced head and neck tumors according to RECIST v1.1.
2. To monitor the pharmacokinetics of GT201 infusion in the treatment of advanced head and neck tumors: duration of back infusion of GT201 in subjects, evaluate expansion status, and correlation with the effectiveness of GT201 infusion. To characterize serum levels of T cell related cytokines such as TNF-α, IFN-γ, IL-6.

Purpose of exploratory study To analysis the changes of cell phenotypes and distribution of cell populations. To track the expansion of TIL clones by detecting T cell receptors (TCR)and other possible cytokines in peripheral blood.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 1.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;
* 2.Known mental illness, alcoholism, drug use or substance abuse;
* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
* 4.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;
* 5.The investigators determine that other conditions that make the patient not suitable for enrollment.

Primary outcomes:
measure: Incidience and severity of adverse events per CTCAE 5.0
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
Study officials:
References: