MelanomaPhase 2MIZAR-003NCT06703398
A Study of GC101 TIL in Advanced Melanoma
A Phase 2 study testing GC101 TIL and dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin in people with Melanoma, run by Shanghai Juncell Therapeutics at 1 site in China.
Trial summary
98 participants will be randomly assigned 1:1 to the experimental group and the control group for the Phase II clinical trial，this trail is expected to be finished in 24 months Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- GC101 TIL and dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2024to 20 Dec 2027
- Phase
- Phase 2
- 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
- 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) ;
- Patients who have failed or resisted to PD-1 antibodies；
- Patients must have failed or resisted to at least two frontlines systemic tehrapy(if knowed with BRAF V600 mutate, then need to failed to BRAF/MEK inhibitor; if knowed with NRAS mutate, then need to failed to Tunlametinib) ；
- 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 ) even after TIL sampling and resection of surgically resectable tissue;
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- ECOG performance status 0-1;
- Expected survival time >3 months;
- With sufficient hematology and end-organ function;
- Good compliance and able to adhere to the study visit plan and other agreement requirements.
Who cannot join
- Patients receive any drug under study within 28 days prior to screening;
- 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, hypothyroidism 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;
- With other serious organic diseases or mental disorders;
- Suffering from systemic active infection requiring treatment, with positive blood culture or imaging evidence of infection, including but not limited to active tuberculosis;
- Suffering from infectious diseases such as hepatitis B, hepatitis C, syphilis, AIDS, etc;
- Individuals with active autoimmune diseases (such as eczema, vitiligo, psoriasis, alopecia or Graves' disease that do not require systemic treatment within the past two years, other autoimmune diseases that are not expected to recur, hypothyroidism that only requires thyroid hormone replacement therapy, and type 1 diabetes that only requires insulin replacement therapy can be enrolled);
- Any NCI CTCAE 5.0 immune-related adverse reaction (iRAE) grade ≥3 occurred during any previous immunotherapy(except for cases where it recovered to ≤1 after treatment or reached stability as assessed by the investigator);
- Those who had undergone organ allotransplantation, allogeneic stem cell transplantation and renal replacement therapy;
- Pulmonary fibrosis, interstitial lung disease (including past history and current condition), acute lung disease;
- Those with leptomeningeal metastasis;
- Patients with clinical symptoms of central nervous system metastases (such as cerebral edema, requiring hormone intervention, or progression of brain metastases), Patients who have previously received treatment for brain metastases, such as those who have maintained clinical stability (MRI) for at least 2 months and have stopped systemic hormone therapy (dose > 10mg/ day prednisone or other equivalent hormones) for more than 4 weeks, can be included;
- Women who are pregnant or breastfeeding;
- There is a history of TIL cell therapy, allogeneic T cell therapy, or NK cell therapy within 6 months;
- Situations that are not suitable for enrollment assesed by investigators;
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
Beijing Cancer Hospital
Beijing
Jun Guo, +861088121122, guoj307@126.com
About this study
Official title: A Multicenter, Randomized, Controlled,Open Label, Phase II Trial of Autologous Tumor Infiltrating Lymphocytes (GC101 TIL) in Subjects With Advanced Melanoma
98 participants will be randomly assigned 1:1 to the experimental group and the control group for the Phase II clinical trial，this trail is expected to be finished in 24 months
Read the detailed description
This study is to investigate the efficacy and safety of autologous tumor infiltrating lymphocyte (GC101 TIL) therapy versus investigator's choice of chemotherapy 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 cyclophosphamide and hydroxychloroquine.
- Conditions
- Melanoma
- Being tested
- GC101 TIL, dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin
- Keywords
- Randomized-controlled trial, Tumor Infiltrating Lymphocytes, Chemotherapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC101 TILBiological
Patients with advanced melanoma (excluding uveal melanoma) who have failed to PD-1 antibodies (if BRAF mutation is present, BRAF and MEK inhibitors have failed; if NRAS mutation is present, tunlametinib have failed) and are ineligible for resection
dacarbazine, temozolomide, paclitaxel ,platinum or cisplatinDrug
monotherapy or combination of dacarbazine, temozolomide, paclitaxel, platinum or cisplatun, and the chemotherapy's dosage could refer to the drug label or the relevant treatment guideline, the final decision is up to investigator
| Study group | Role | What they receive |
|---|---|---|
| GC101 TIL group | Experimental | A 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 sintilimab. Receives: Biological: GC101 TIL |
| Investigator's choice of chemotherapy | Active comparator | monotherapy or combination of dacarbazine, temozolomide, paclitaxel,carboplatin or cisplatin, and the chemotherapy's dosage could refer to the drug label or the relevant treatment guideline, the final decision is up to investigator. Receives: Drug: dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival (PFS) confirmed by the Independent Review Committee (IRC) according to RECIST 1.1
Measured: Every 6 weeks for 12 months
Secondary outcomes (6)
Overall survival
Overall survival (OS) and OS rates at 6, 12, and 18 months
Measured: Maximum 2 years
Progression-free survival
PFS assessed by investigators according to RECIST 1.1 and PFS assessed by IRC and investigators according to iRECIST
Measured: Every 6 weeks for 12 months
Objective Response Rate
Objective Response Rate (ORR) assessed by IRC and investigators according to RECIST 1.1 and iRECIST
Measured: Maximum 360 days
Disease Control Rates
Disease Control Rates (DCR) assessed by IRC and investigators according to RECIST 1.1 and iRECIST
Measured: Every 6 weeks for 12 months
Duration of Response
Duration of Response (DoR) assessed by IRC and investigators according to RECIST 1.1 and iRECIST
Measured: Every 6 weeks for 12 months
Adverse Events
Incidence of adverse events associated with GC101 TIL retransfusion
Measured: Maximum 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start20 Dec 2024
- Primary completion12 May 2026
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 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
- NCT06703398
- Sponsor's protocol ID
- GC101 TIL-MM-II
- Acronym
- MIZAR-003
- Status last verified
- Aug 2026
- First submitted
- 21 Nov 2024
- 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 Multicenter, Randomized, Controlled,Open Label, Phase II Trial of Autologous Tumor Infiltrating Lymphocytes (GC101 TIL) in Subjects With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT06703398
- Acronym / sponsor ID
- MIZAR-003 / GC101 TIL-MM-II
- Conditions
- Melanoma
- Keywords
- Randomized-controlled trial, Tumor Infiltrating Lymphocytes, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Shanghai Juncell TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 25 Nov 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.
98 participants will be randomly assigned 1:1 to the experimental group and the control group for the Phase II clinical trial，this trail is expected to be finished in 24 months
Detailed description
This study is to investigate the efficacy and safety of autologous tumor infiltrating lymphocyte (GC101 TIL) therapy versus investigator's choice of chemotherapy 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 cyclophosphamide and hydroxychloroquine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC101 TIL group | Experimental | Biological: GC101 TILA 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 sintilimab. |
| Investigator's choice of chemotherapy | Active comparator | Drug: dacarbazine, temozolomide, paclitaxel ,platinum or cisplatinmonotherapy or combination of dacarbazine, temozolomide, paclitaxel,carboplatin or cisplatin, and the chemotherapy's dosage could refer to the drug label or the relevant treatment guideline, the final decision is up to investigator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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) ;
- Patients who have failed or resisted to PD-1 antibodies；
- Patients must have failed or resisted to at least two frontlines systemic tehrapy(if knowed with BRAF V600 mutate, then need to failed to BRAF/MEK inhibitor; if knowed with NRAS mutate, then need to failed to Tunlametinib) ；
Key exclusion criteria (21 listed)
- Patients receive any drug under study within 28 days prior to screening;
- 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, hypothyroidism 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;
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 |
|---|---|---|
| GC101 TILPatients with advanced melanoma (excluding uveal melanoma) who have failed to PD-1 antibodies (if BRAF mutation is present, BRAF and MEK inhibitors have failed; if NRAS mutation is present, tunlametinib have failed) and are ineligible for resection | Biological | GC101 TIL group |
| dacarbazine, temozolomide, paclitaxel ,platinum or cisplatinmonotherapy or combination of dacarbazine, temozolomide, paclitaxel, platinum or cisplatun, and the chemotherapy's dosage could refer to the drug label or the relevant treatment guideline, the final decision is up to investigator | Drug | Investigator's choice of chemotherapy |
Primary outcome
Progression-free survival
Time frame: Every 6 weeks for 12 months
Progression-free survival (PFS) confirmed by the Independent Review Committee (IRC) according to RECIST 1.1
6 secondary outcomes
Overall survival
Time frame: Maximum 2 years
Progression-free survival
Time frame: Every 6 weeks for 12 months
Objective Response Rate
Time frame: Maximum 360 days
Disease Control Rates
Time frame: Every 6 weeks for 12 months
Duration of Response
Time frame: Every 6 weeks for 12 months
Adverse Events
Time frame: Maximum 360 days
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GC101 TIL and dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin in people with Melanoma, 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 10 inclusion and 21 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?
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?
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 Jun Guo, Prof. Dr. Med (86-10-88121122, guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Every 6 weeks for 12 months). 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.