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Advanced Solid TumorEarly Phase 1NCT05087745

A Clinical Study on TIL for the Treatment of Advanced Solid Tumors

A Early Phase 1 study testing Tumor Infiltrating Lymphocytes in people with Advanced Solid Tumor and Tumor Infiltrating Lymphocytes, run by Shanghai Juncell Therapeutics at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced 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
What is being tested?
Tumor Infiltrating Lymphocytes
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
10 Dec 2021to 10 Dec 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 solid 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.

Clinical GC contact

086-18001759113

clinicaltrails@juncell.com

China1 site, 1 recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, Zhejiang, 310016

    Hui Lin

    Hua Ling Chen

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study on Tumor Infiltrating Lymphocytes for the Treatment of Advanced Solid Tumors

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced 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.

Being tested
Tumor Infiltrating Lymphocytes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tumor Infiltrating LymphocytesBiological

    Adoptive transfer of 1x10^9-5x10^10 autologous TILs to patients i.v. in 30-120 minutes.

Study groups in NCT05087745
Study groupRoleWhat they receive
Tumor Infiltrating LymphocytesExperimental1x10^9-5x10^10 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    To characterize the safety profile of GC101 (TIL) in patients with recurrent, metastatic, or persistent solid tumors as assessed by incidence of adverse events.

    Measured: 6 months

  2. 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 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

  3. 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

  4. 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

  5. Progression-Free Survival (PFS)

    The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1

    Measured: Up to 36 months

  6. Overall Survival (OS)

    The length of time from the date of the start of TIL treatment that the patients are still alive

    Measured: Up to 36 months

Secondary outcomes (1)

  1. Change in Quality of Life

    Comparison of patients' quality of life before and after TIL treatment

    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.

  1. First posted21 Oct 2021
  2. Study start10 Dec 2021
  3. Primary completion10 Dec 2027 (estimated)
  4. Study completion10 Dec 2029 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05087745
Sponsor's protocol ID
GC101-ZJ01
Status last verified
Aug 2026
First submitted
12 Oct 2021
Last updated
5 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Tumor Infiltrating Lymphocytes in people with Advanced Solid Tumor and Tumor Infiltrating Lymphocytes, 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 Clinical GC (086-18001759113, clinicaltrails@juncell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05087745.

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.

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