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Tumor Infiltrating LymphocytesPhase 1/2MIZAR-002NCT06120712

A Study of GC101 TIL in Advanced Melanoma (BZ)

A Phase 1/2 study testing GC101 TIL in people with Tumor Infiltrating Lymphocytes and Safety, run by Shanghai Juncell Therapeutics at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 20 months. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Tumor Infiltrating Lymphocytes, Safety, Melanoma
What is being tested?
GC101 TIL
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
8 Nov 2023to 12 Nov 2025
Phase
Phase 1/2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;
  • Aged ≥18 years and ≤75 years, regardless of gender;
  • Patients with unresectable advanced, recurrent or metastatic melanoma (excluding uveal melanoma) who have failed standard treatment with PD-1 antibodies, etc. (if BRAF mutation is carried, BRAF and MEK inhibitor treatment failure);
  • TILs can be isolated from a surgically resectable tumor region: the tissue volume must be >150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or progressed after local treatment;
  • There are still at least 1 measurable lesion (according to RECIST1.1 criteria [see Appendix 4]) even after TIL sampling and resection of surgically resectable tissue;
  • ECOG performance status 0-1;
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  • Expected survival time >3 months;
  • With sufficient hematology and end-organ function as defined by the following laboratory test results, the test results must be completed and issued within 7 days before tumor tissue collection:
  • White Blood Cell (WBC)≥2.5×10^9/L#
  • Absolute Lymphocyte Count (ANC)≥1.5×10^9/L;
  • Absolute Lymphocyte Count(ALC)≥0.7×10^9/L;
  • Platelet≥100×10^9/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#
  • * Premenopausal women who have not undergone sterilization surgery must agree to use effective contraception measures from the start of study treatment (preconditioning) to one year after cell infusion, and the serum pregnancy test during the screening period must be negative; *Men who have not undergone sterilization surgery must agree to use effective contraception measures from the start of study treatment (preconditioning) until one year after cell infusion;
  • No absolute or relative contraindications for surgery;
  • Any melanoma treatment methods, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, or traditional Chinese medicine/herbal medicine treatment with anti-tumor indications, must be stopped 28 days before infusion. If a small molecular targeted drug was used in the previous treatment, the withdrawal time can be shortened to 5 half-lives of the drug used;
  • Good compliance and able to adhere to the study visit plan and other agreement requirements.

Who cannot join

  • Participation in a clinical trial of another drug or biologic therapy or receipt of a comparable cellular therapy within 28 days prior to infusion;
  • Combination of 2 or more malignant tumors, except: Eradicated malignant tumors that have been inactive for ≥5 years prior to study entry and are at minimal risk of recurrence; adequately treated non-melanoma skin cancer or malignant nevus of freckle-like nevus without evidence of disease recurrence; adequately treated carcinoma in situ without evidence of disease recurrence;
  • Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;
  • Has not recovered from a prior procedure or treatment-related adverse reaction to ≤ grade 1 nci ctcae 5.0 (except for toxicities such as alopecia, etc., which in the judgment of the investigator pose no safety risk);
  • Known history of allergy to streptomycin, ciprofloxacin, or micafungin or allergy to any component of the infused product formulation;
  • Uncontrolled co-morbidities including, but not limited to, uncontrolled arterial hypertension (systolic blood pressure ≥160 mmhg and/or diastolic blood pressure ≥100 mmhg) even with standardized treatment or any unstable cardiovascular disease including transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina pectoris within 6 months prior to enrollment; new york heart association ( nyha class iii or iv congestive heart failure with an ejection fraction <50%; or severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias, degree ii-iii atrioventricular block, etc., requiring clinical intervention; ecg results showing clinically significant abnormalities or a qtcf ≥450ms (if the first test is abnormal, it may be retested at least 5 minutes apart twice and the combined result/mean value to determine eligibility) ;
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  • Patients with esophageal or gastric varices that require immediate intervention (e.g., taping or sclerotherapy) or are considered to be at high risk for bleeding based on the opinion of the investigator or consultation with a gastroenterologist or hepatologist, have evidence of portal hypertension (including splenomegaly detected on imaging), or have a prior history of variceal bleeding must have undergone endoscopic evaluation within 3 months prior to enrollment;
  • Uncontrolled metabolic disorders, such as diabetes mellitus known to be uncontrolled, or other non-malignant organ or systemic diseases or secondary reactions to cancer, and which can lead to higher medical risk and/or uncertainty in survival evaluation;
  • Hepatic encephalopathy, hepatorenal syndrome or child-pugh class b or more severe cirrhosis, liver failure;
  • Comorbidity with other serious organic or psychiatric disease;
  • Have an active systemic infection requiring treatment with positive blood cultures or imaging evidence of infection, including but not limited to active tuberculosis;
  • Be hiv-positive, have a positive serologic test for syphilis, or have clinically active hepatitis a, b, or c, including viral carriers: Hepatitis b, excluding those who are HBsAg-positive; hepatitis c, excluding those who are HCVAb-positive;
  • Who have used, or in the judgment of the investigator have a co-morbid condition requiring the use of glucocorticosteroids or other immunosuppressive medications during the trial within 4 weeks prior to pretreatment, excluding topical glucocorticosteroids by nasal spray, inhalation, or other routes or physiologic doses of systemic glucocorticosteroids (i.e., no more than 10 mg/day of prednisone or equivalent dose of other glucocorticosteroids), or who have an active autoimmune disease ( eczema, vitiligo, psoriasis, alopecia areata, or grave's disease that does not require systemic treatment within the last 2 years, other autoimmune diseases that are not expected to recur, and hypothyroidism requiring only thyroid hormone replacement therapy, and subjects with type i diabetes mellitus requiring only insulin replacement therapy may be enrolled);
  • Any nci ctcae5.0 immune-related adverse effect (irae) grade ≥ 3 during any prior period of immunotherapy receipt;
  • History of organ allograft, allogeneic stem cell transplantation and renal replacement therapy;
  • Pulmonary fibrosis, interstitial lung disease (both past history and current), and acute lung disease;
  • Clinically uncontrollable third space effusions, such as pleural and abdominal effusions that cannot be controlled by drainage or other means prior to enrollment;
  • Patients with known molluscum contagiosum metastases;
  • Patients with clinically symptomatic central nervous system metastases (e.g., cerebral edema, need for hormonal intervention, or progression of brain metastases). Patients with prior treatment for brain metastases, such as clinical stability (mri) that has been maintained for at least 2 months and who have discontinued systemic hormone therapy (dose >10 mg/day prednisone or other equipotent hormone) for >4 weeks may be included;
  • Women who are pregnant or breastfeeding;
  • History of allogeneic t-cell and nk-cell therapy;
  • If the investigator believes that other circumstances are not suitable for enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing

Other trials in China

About this study

Official title: An Open, Single-armed, Phase Ib Study to Evaluate the Safety and Efficacy Using Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Advanced Melanoma

20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 20 months.

Read the detailed description

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine and cyclophosphamide.

Being tested
GC101 TIL
Medical subject headings
Melanoma, Drug-Related Side Effects and Adverse Reactions

What participants receive

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

  • GC101 TILBiological

    Patients with advanced, recurrent or metastatic melanoma (excluding uveal melanoma) who have failed standard treatment such as PD-1 antibodies (if BRAF mutation is present, BRAF and MEK inhibitors have failed) and are ineligible for resection."

Study groups in NCT06120712
Study groupRoleWhat they receive
Participants with advanced malignant melanoma using cryopreserved GC101 TILExperimentalA tumor sample is resected from each participant and cultured ex vivo to expand the population of autologous tumor infiltrating lymphocytes injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL followed Pembrolizumab.
Receives: Biological: GC101 TIL

What is being measured

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

  1. Adverse Events

    Incidence of adverse events associated with GC101 TIL retransfusion

    Measured: Up to Day 28

  2. Objective Response Rate

    Proportion of subjects in total cases in complete or partial response (RECIST v1.1 criteria)

    Measured: Up to Day 90

Secondary outcomes (8)

  1. Adverse Events

    Incidence of adverse events associated with GC101 TIL retransfusion

    Measured: Maximum 360 days

  2. Objective Response Rate

    Proportion of subjects in total cases in complete or partial response (RECIST v1.1 criteria) during the study

    Measured: Maximum 360 days

  3. Best overall response

    Optimal efficacy recorded from the start of treatment until disease progression or relapse (RECIST v1.1 and iRECIST)

    Measured: Maximum 360 days

  4. Disease Assessment for 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

  5. Disease Assessment for 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

  6. Disease Assessment for 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

  7. Immunologic competence

    TBNK cell subtypes and cytokines in peripheral blood

    Measured: Every 6 weeks for 12 months

  8. Quality of Life Assessmen

    EORTC Quality of Life Questionnaire - Core 30, Questions rated between 1-4, self-rated 1-7, higher scores mean a better outcome.

    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.

  1. First posted7 Nov 2023
  2. Study start8 Nov 2023
  3. Primary completion12 Nov 2024
  4. Study completion12 Nov 2025

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
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06120712
Sponsor's protocol ID
GC101 TIL-MM-Ib
Acronym
MIZAR-002
Status last verified
Nov 2025
First submitted
1 Nov 2023
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GC101 TIL in people with Tumor Infiltrating Lymphocytes and Safety, 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 24 inclusion and 22 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: finished, as of the sponsor's last update on 23 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Adverse Events (time frame: Up to Day 28). 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?

On the ClinicalTrials.gov record for NCT06120712.

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 23 Dec 2025.

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