Solid TumorPhase 1KUNLUN-001NCT06375187
A Study of GC203 TIL in Advanced Malignant Solid Tumors
A Phase 1 study testing Engineering Tumor Infiltrating Lymphocytes in people with Solid Tumor and Gynecologic Cancer, run by Shanghai Juncell Therapeutics at 1 site in China.
Trial summary
A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Gynecologic Cancer, Breast Cancer
- What is being tested?
- Engineering Tumor Infiltrating Lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2024to 1 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.
- 2. Patients must be ≥18 and ≤75 years of age at the time of consent. 3. Patients with advanced metastatic solid tumors with clear pathological diagnosis have failed standard therapy (standard therapy is defined as existing guidelines and consensus recommended therapy [including but not limited to chemotherapeutic therapy, radiotherapy, mutation-targeted therapy, immunotherapy, and surgery]) , including but not limited to gynecological tumors (ovarian cancer, endometrial cancer, cervical cancer), breast cancer, gastrointestinal Cancer, lung cancer.
- 4. Patients have feasible tissue areas for tumor resection/puncture to generate GC203 TIL, the total volume of the tissue > 400mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency therapy, oncolytic virus, etc.) or has progressed after local treatment; 5. At least one measurable target lesion before preconditioning, as defined by RECIST1.1.
- 6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 7. Patients must have an estimated life expectancy of ≥3 months. 8. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function:
- Absolute Neutrophil Count (ANC)≥1.0×10^9/L;
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- Absolute Lymphocyte Count(ALC)≥0.5×10^9/L;
- Platelet≥80×10^9/L；
- International Normalized Ratio（INR）≤1.5×ULN;
- Activated Partial Thromboplastin Time（APTT）≤1.5×ULN;
- Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine Clearance≥60mL/min
- Urinalysis: urine protein less than 2+, or 24-hour urine protein <1g;
- Alanine aminotransferase(AST/SGOT) ≤3×ULN;
- Alanine aminotransferase (ALT/SGPT) ≤3×ULN;
- Total Bilirubin(TBIL)≤1.5×ULN； 9. Women of child-bearing potential (WCBP), must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.
- 10. Patients must have no contraindications for surgery or biopsy. 11. Patients have good compliance and be able to adhere to research access plans and other protocol requirements.
Who cannot join
- Participate in clinical trials of other drugs or biologic therapies within 4 weeks before enrollment;
- Participants who have had a history of allogeneic T cell therapy; gene engineering autologous cell therapy within 1 years.
- Patients who have received systemic antitumor therapy within 4 weeks.
- Patients who have had another primary malignancy within the previous 5 years
- Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
- Patients with a history of hypersensitivity to any component of the study drugs
- Patients who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Xiaohua Wu, PhD, +862164175590, Wu.xh@fudan.edu.cn
About this study
Official title: A Phase I Study to Evaluate the Safety and Efficacy of Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL)in Patients With Advanced Malignant Solid Tumors
A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors
- Being tested
- Engineering Tumor Infiltrating Lymphocytes
- Keywords
- Adoptive cell therapy, Tumor Infiltrating Lymphocytes
- Medical subject headings
- Breast Neoplasms, Gastrointestinal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engineering Tumor Infiltrating LymphocytesBiological
Also called GC203 TIL
A tumor sample is resected from each participant and cultured ex vivo to generate the engineered tumor infiltrating lymphocytes. After lymphodepletion, patients are infused GC203 TIL followed low-dose PD-1 antibody.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) Receives: Biological: Engineering Tumor Infiltrating Lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Tolerance Dose
Measured: Up to Day 28
Dose Limiting Toxicity
Measured: Up to Day 28
Adverse Events
Measured: Maximum 360 days
Secondary outcomes (6)
Objective Response Rate
Evaluate the efficacy endpoints of ORR by the investigator with RECIST v1.1 and iRECIST
Measured: Every 6 weeks for 12 months
Duration of Response
Evaluate the efficacy endpoints of DoR by the investigator with RECIST v1.1 and iRECIST
Measured: Every 6 weeks for 12 months
Disease Control Rate
Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST
Measured: Every 6 weeks for 12 months
Progression-Free Survival
Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST
Measured: Every 6 weeks for 12 months
Overall Survival
Evaluate the efficacy endpoints of OS by the investigator with RECIST v1.1 and iRECIST
Measured: Every 6 weeks for 12 months
Quality of Life Assessment
Evaluate with EORTC QLQ-C30
Measured: Every 6 weeks for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start29 May 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Shanghai Juncell TherapeuticsThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Juncell Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375187
- Sponsor's protocol ID
- GC203 TIL-ST-Ⅰ
- Acronym
- KUNLUN-001
- Status last verified
- Dec 2025
- First submitted
- 16 Apr 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Efficacy of Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL)in Patients With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06375187
- Acronym / sponsor ID
- KUNLUN-001 / GC203 TIL-ST-Ⅰ
- Keywords
- Adoptive cell therapy, Tumor Infiltrating Lymphocytes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Juncell TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 May 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 19 Apr 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.
A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: Engineering Tumor Infiltrating LymphocytesEngineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.
- 2. Patients must be ≥18 and ≤75 years of age at the time of consent. 3. Patients with advanced metastatic solid tumors with clear pathological diagnosis have failed standard therapy (standard therapy is defined as existing guidelines and consensus recommended therapy [including but not limited to chemotherapeutic therapy, radiotherapy, mutation-targeted therapy, immunotherapy, and surgery]) , including but not limited to gynecological tumors (ovarian cancer, endometrial cancer, cervical cancer), breast cancer, gastrointestinal Cancer, lung cancer.
- 4. Patients have feasible tissue areas for tumor resection/puncture to generate GC203 TIL, the total volume of the tissue > 400mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency therapy, oncolytic virus, etc.) or has progressed after local treatment; 5. At least one measurable target lesion before preconditioning, as defined by RECIST1.1.
- 6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 7. Patients must have an estimated life expectancy of ≥3 months. 8. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function:
Key exclusion criteria (7 listed)
- Participate in clinical trials of other drugs or biologic therapies within 4 weeks before enrollment;
- Participants who have had a history of allogeneic T cell therapy; gene engineering autologous cell therapy within 1 years.
- Patients who have received systemic antitumor therapy within 4 weeks.
- Patients who have had another primary malignancy within the previous 5 years
- Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
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 |
|---|---|---|
| Engineering Tumor Infiltrating LymphocytesAlso: GC203 TILA tumor sample is resected from each participant and cultured ex vivo to generate the engineered tumor infiltrating lymphocytes. After lymphodepletion, patients are infused GC203 TIL followed low-dose PD-1 antibody. | Biological | Treatment Arm |
Primary outcome
Maximal Tolerance Dose
Time frame: Up to Day 28
Dose Limiting Toxicity
Time frame: Up to Day 28
Adverse Events
Time frame: Maximum 360 days
6 secondary outcomes
Objective Response Rate
Time frame: Every 6 weeks for 12 months
Duration of Response
Time frame: Every 6 weeks for 12 months
Disease Control Rate
Time frame: Every 6 weeks for 12 months
Progression-Free Survival
Time frame: Every 6 weeks for 12 months
Overall Survival
Time frame: Every 6 weeks for 12 months
Quality of Life Assessment
Time frame: Every 6 weeks for 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Engineering Tumor Infiltrating Lymphocytes in people with Solid Tumor and Gynecologic Cancer, run by Shanghai Juncell Therapeutics at 1 site 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 16 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huajun Jin, PhD (+8621-69110327, clinicaltrials@juncell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Tolerance Dose (time frame: Up to Day 28). The study lists 3 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 11 Dec 2025.