To hear about similar clinical trials, please enter your email below
Trial Title:
Autologous Tumor-Infiltrating Lymphocyte (GTE-001 Injection ) for Treatment of Patients With Advanced Lung Adenocarcinoma
NCT ID:
NCT06491225
Condition:
Advanced Lung Adenocarcinoma；Adult
Conditions: Official terms:
Adenocarcinoma
Adenocarcinoma of Lung
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
GTE001 injection
Description:
GTE-001 injection to treat Advanced lung adenocarcinoma
Arm group label:
GTE001 injection treatment group
Summary:
This study is a Multiple centers, open design aimed at evaluating the safety,efficacy and
Production feasibility of Autologous Tumor-Infiltrating Lymphocyte (GTE-001 injection )
for treatment of patients with Advanced lung adenocarcinoma,And evaluate potential
biomarkers related to GTE-001 activity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Voluntarily join the study, signed informed consent form， willing and able to
comply with the study protocol;
-
2. Age ≥18 years old;
-
3. Advanced lung adenocarcinoma that progresses after recurrence or first-line
chemotherapy；
-
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
-
5. Expected survival time of ≥ 3 months;
-
6. Good function of vital organs;
-
7. Subjects entering this study due to disease progression must have an imaging
record of disease progression before tumor sampling;
-
8. At least one measurable target lesion that meets the definition of RECIST v1.1
after tumor sampling.
Exclusion Criteria:
- 1.Subject has previously received an allogeneic stem cell transplant or organ
allograft,Subject has previously received engineered cell therapy,Prior FOLR1
directed therapy is not allowed unless it had been with an approved agent in the
indication;
- 2.Subject has undergone surgery or received radiotherapy, immunotherapy, targeted
therapy agents, anticancer vaccines, systemic steroids, or chemotherapy within 2
weeks of enrolment. Targeted agents, such as tyrosine kinase inhibitors, may be
continued until 5 half-lives before enrolment;
- 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning
to become pregnant within 12 months after cell infusion;
- 4.History of central nervous system (CNS) disorder,History of autoimmune
disease,History of primary immunodeficiency;
- 5.The investigators determine that other conditions that make the patient not
suitable for enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmin Lu, PHD
Phone:
+86 （021）13671774876
Email:
renjilhm@163.com
Start date:
July 18, 2024
Completion date:
July 18, 2027
Lead sponsor:
Agency:
Grit Biotechnology
Agency class:
Industry
Source:
Grit Biotechnology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06491225
