Advanced Solid TumorsEarly Phase 1NCT04967833
A Study of GC101 TIL in Advanced Solid Tumors (TR)
A Early Phase 1 study testing Tumor Infiltrating Lymphocytes (TIL) in people with Advanced Solid Tumors, run by Shanghai Juncell Therapeutics at 1 site in China.
Trial summary
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with Advanced malignant solid tumors.Autologous TILs are expanded from tumor resections or biopsies and infused i.v. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Tumor Infiltrating Lymphocytes (TIL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2021to 22 Apr 2029
- Phase
- Early 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
- Age: 18 years to 75 years;
- Histologically diagnosed as primary/relapsed/metastasized malignant tumors;
- Expected life-span more than 3 months;
- Karnofsky≥60% or ECOG score 0-2;
- Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
- Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
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- At least 1 evaluable tumor lesion;
- Hematology and Chemistry（within 7 days prior to enrollment）:
- Absolute count of white blood cells≥2.5×10^9/L;
- Absolute count of neutropils≥1.5×10^9/L;
- Absolute count of lymphocytes ≥0.7×109/L；
- Platelet count≥100×10^9；
- hemoglobin≥90 g/L;
- Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);
- International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);
- Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min;
- Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN);
- Totol bilirubin≤1.5×ULN;
- No absolute or relative contraindications to operation or biopsy;
- Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion；
- Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;
- Be able to understand and sign the informed consent document;
- Be able to stick to follow-up visit plan and other requirements in the agreement.
Who cannot join
- Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
- Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
- Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
- Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
- Severe physical or mental diseases;
- Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
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- Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
- History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;
- Having received immunotherapy and developed irAE level greater than Level 3;
- Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);
- Females in pregnancy or lactation;
- History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;
- Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.
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
Tongren Hospital Shanghai Jiao Tong University School Of Medicine.
Shanghai
LiJun Ma, 626595330@qq.com
About this study
Official title: A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Malignant Solid Tumors
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with Advanced malignant solid tumors.Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
- Conditions
- Advanced Solid Tumors
- Being tested
- Tumor Infiltrating Lymphocytes (TIL)
- Keywords
- TIL,Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Infiltrating Lymphocytes (TIL)Biological
Biological: Tumor Infiltrating Lymphocytes (TIL) Adoptive transfer of 1x10^9-5x10^10 autologous TILs to patients i.v. in 30-120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Tumor Infiltrating Lymphocytes | Experimental | 1x10^9-5x10^10 in vitro expanded autologous TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide. Receives: Biological: Tumor Infiltrating Lymphocytes (TIL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events(AE)
To characterize the safety profile of GC101 TIL in patients with recurrent, metastatic, or persistent solid tumor as assessed by incidence of adverse events.
Measured: 6 month
Objective Response Rate (ORR)
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1):
ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD.
( Except baseline evaluation within 28 days before GC101 TIL infusion，PET/CT scan will be performed at 6 weeks after TIL infusion, and than every 6 weeks for 6 months, and then every 6 months after that for up to 3 years)
Measured: Up to 36 months
Secondary outcomes (4)
Disease Control Rate (DCR）
Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST v1.1： DCR (proportion of patients) = # with CR + # with PR + # with SD / # with CR + # with PR + # with SD + # with PD.
Measured: Up to 36 months
Duration of Response (DOR)
The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1
Measured: Up to 36 months
Progression-Free Survival (PFS)
The time length between GC101 TIL infusion and confirmed subsequent disease progression according to RECIST 1.1
Measured: Up to 36 months
Overall Survival (OS)
The length of time from the date of the start of GC101-TIL treatment that the patients are still alive.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start22 Apr 2021
- Primary completion22 Dec 2027 (estimated)
- Study completion22 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Juncell Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Tong Ren Hospital
- Responsible party
- Sponsor
- Investigators
- LiJun Ma, Principal investigator, Shanghai Tong Ren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967833
- Sponsor's protocol ID
- GC101-2021-TR-ST
- Status last verified
- Sep 2025
- First submitted
- 10 Jun 2021
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT04967833
- Acronym / sponsor ID
- GC101-2021-TR-ST
- Conditions
- Advanced Solid Tumors
- Keywords
- TIL,Solid Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Juncell TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Tong Ren Hospital
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 22 Dec 2027 (estimated)
- Study completion
- 22 Apr 2029 (estimated)
- First posted
- 20 Jul 2021 (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 to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with Advanced malignant solid tumors.Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor Infiltrating Lymphocytes | Experimental | Biological: Tumor Infiltrating Lymphocytes (TIL)1x10^9-5x10^10 in vitro expanded autologous TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age: 18 years to 75 years;
- Histologically diagnosed as primary/relapsed/metastasized malignant tumors;
- Expected life-span more than 3 months;
- Karnofsky≥60% or ECOG score 0-2;
- Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
Key exclusion criteria (13 listed)
- Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
- Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
- Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
- Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
- Severe physical or mental diseases;
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 |
|---|---|---|
| Tumor Infiltrating Lymphocytes (TIL)Biological: Tumor Infiltrating Lymphocytes (TIL) Adoptive transfer of 1x10^9-5x10^10 autologous TILs to patients i.v. in 30-120 minutes. | Biological | Tumor Infiltrating Lymphocytes |
Primary outcome
Adverse Events(AE)
Time frame: 6 month
To characterize the safety profile of GC101 TIL in patients with recurrent, metastatic, or persistent solid tumor as assessed by incidence of adverse events.
Objective Response Rate (ORR)
Time frame: Up to 36 months
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD. ( Except baseline evaluation within 28 days before GC101 TIL infusion，PET/CT scan will be performed at 6 weeks after TIL infusion, and than every 6 weeks for 6 months, and then every 6 months after that for up to 3 years)
4 secondary outcomes
Disease Control Rate (DCR）
Time frame: Up to 36 months
Duration of Response (DOR)
Time frame: Up to 36 months
Progression-Free Survival (PFS)
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 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 5 Aug 2026.
- 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.
LiJun Ma principal investigator
Shanghai Tong Ren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tumor Infiltrating Lymphocytes (TIL) in people with Advanced Solid Tumors, 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 23 inclusion and 13 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 5 Aug 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 GC Clinical (+86-18001759113, clinicaltrials@juncell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events(AE) (time frame: 6 month). 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 5 Aug 2026.