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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235242
• Other study ID #: GRIT-CD-CHN-201-002
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: January 31, 2027

Study information

• Verified date: February 2024
• Source: Grit Biotechnology
• Contact: Yayi He, PHD
• Phone: +86 13818828623
• Email: doctorjael[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adult
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai
China	Shanghai GoBroad Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Grit Biotechnology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Profile Measured by Grade =3 TRAEs	Safety Profile Measured by Grade =3 TRAEs by CTCAE 5.0	3 years