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

G

Grit Biotechnology

Status

Enrolling

Conditions

Adult
Non-small Cell Lung Cancer

Treatments

Biological: GT201 injection in combination with teraplizumab injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06235242
GRIT-CD-CHN-201-002

Details and patient eligibility

About

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).

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

    1. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;
    1. Age 18 to 70 years old;
    1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
    1. Expected survival time of ≥ 12 weeks;
    1. Good function of vital organs;
    1. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
    1. 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

GT201 treatment group
Experimental group
Treatment:
Biological: GT201 injection in combination with teraplizumab injection

Trial contacts and locations

2

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Central trial contact

Jin Li, PHD; Yayi He, PHD

Data sourced from clinicaltrials.gov

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