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

NCT ID: NCT06235242

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-02

Study Completion Date

2027-01-31

Brief Summary

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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

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Conditions

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Adult Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GT201 treatment group

Group Type EXPERIMENTAL

GT201 injection in combination with teraplizumab injection

Intervention Type BIOLOGICAL

GT201 injection in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer

Interventions

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GT201 injection in combination with teraplizumab injection

GT201 injection in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grit Biotechnology

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Gobroad Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Shanghai GoBroad Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yayi He, PHD

Role: CONTACT

+86 13818828623

Jin Li, PHD

Role: CONTACT

+86 13761222111

Facility Contacts

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Shasha Wang

Role: primary

13641268212

Jin Li, PHD

Role: primary

+86 13761222111

Yayi He, PHD

Role: primary

+86 13818828623

Other Identifiers

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GRIT-CD-CHN-201-002

Identifier Type: -

Identifier Source: org_study_id

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