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Trial Title:
Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients With Advanced Lung Cancer
NCT ID:
NCT06519669
Condition:
Adult
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
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:
GT201 injection
Description:
GT201 injection to treat Advanced lung cancer
Arm group label:
GT201 treatment group
Summary:
This study is a single arm, open design aimed at evaluating the safety and tolerability
of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) for treatment of patients
with Advanced lung cancer,while evaluating pharmacokinetic characteristics and efficacy
assessment.
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 to 70 years old;
-
3. Queue 1: Late stage non-small cell lung cancer without driver genes that have
failed first-line systemic treatment;Queue 2: Small cell lung cancer with
first-line systemic treatment failure;
-
4. Ovarian cancer that progresses after recurrence or first-line chemotherapy；
-
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
-
6. Expected survival time of ≥ 12 weeks;
-
7. Good function of vital organs;
-
8. Subjects entering this study due to disease progression must have an imaging
record of disease progression before tumor sampling;
-
9. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
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/NCT06519669
