GT201 Injection in Combination with Teraplizumab Injection for Treatment of Patients with Non-small Cell Lung Cancer

Not Applicable

Recruiting

• Conditions: Non-small Cell Lung Cancer; Adult
• Interventions: Biological: GT201 injection in combination with teraplizumab injection

• Registration Number: NCT06235242
• Lead Sponsor: Grit Biotechnology

Brief Summary

This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-31
• Study Start: 2024-02-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• 4. Expected survival time of ≥ 12 weeks;
• 5. Good function of vital organs;
• 6. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
• 7. 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 preconditioning by lymphodepletion,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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GT201 treatment group	GT201 injection in combination with teraplizumab injection	-

Primary Outcome Measures

Name	Time	Method
Safety Profile Measured by Grade ≥3 TRAEs	3 years	To characterize the safety profile of autologous TIL injection (GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidience and severity of adverse events per CTCAE 5.0

Trial Locations

Locations (3)

Beijing Gobroad Hospital; 🇨🇳 Beijing, Beijing, China

Shanghai East Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai GoBroad Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China