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

March 18, 2024 updated by: Grit Biotechnology

A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT201 Injection ) in Combination With Teraplizumab Injection for Treatment of Patients With Non-small Cell Lung Cancer

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Not yet recruiting
        • Shanghai East Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200120
        • Recruiting
        • Shanghai GoBroad Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GT201 treatment group
Biological: GT201 injection in combination with teraplizumab injection
GT201 injection in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Profile Measured by Grade ≥3 TRAEs
Time Frame: 3 years
Safety Profile Measured by Grade ≥3 TRAEs by CTCAE 5.0
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grit Biotechnology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRIT-CD-CHN-201-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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