AdultNCT06519669
Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients With Advanced Lung Cancer
A study testing GT201 injection in people with Adult and Lung Cancer, run by Grit Biotechnology at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adult, Lung Cancer
- What is being tested?
- GT201 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesChina
- Study dates
- 18 Jul 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- 5. Expected survival time of ≥ 12 weeks;
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
China2 sites
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102200
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT201 Injection ) for Treatment of Patients With Advanced Lung Cancer
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.
- Conditions
- Adult, Lung Cancer
- Being tested
- GT201 injection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT201 injectionBiological
GT201 injection to treat Advanced lung cancer
| Study group | Role | What they receive |
|---|---|---|
| GT201 treatment group | Experimental | Not described Receives: Biological: GT201 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
Measured: 3 years
Incidence and severity of adcersed events per CTCAE 5.0
To characterize the safety profile of autologous TIL injection（GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start18 Jul 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Why it stopped: The study was terminated from a business perspective.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultStudies of the same condition, open and under way.
- More trials run by Grit BiotechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grit Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519669
- Sponsor's protocol ID
- GRIT-CD-CHN-201-016
- Status last verified
- Apr 2026
- First submitted
- 19 Jul 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT201 Injection ) for Treatment of Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT06519669
- Acronym / sponsor ID
- GRIT-CD-CHN-201-016
- Conditions
- Adult, Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated from a business perspective.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Grit BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GT201 treatment group | Experimental | Biological: GT201 injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- 5. Expected survival time of ≥ 12 weeks;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GT201 injectionGT201 injection to treat Advanced lung cancer | Biological | GT201 treatment group |
Primary outcome
Objective response rate
Time frame: 3 years
To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
Incidence and severity of adcersed events per CTCAE 5.0
Time frame: 3 years
To characterize the safety profile of autologous TIL injection（GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0
Results and safety
The study was stopped early (reason given: The study was terminated from a business perspective.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GT201 injection in people with Adult and Lung Cancer, run by Grit Biotechnology at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated from a business perspective.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.