Tumor Infiltrating LymphocytesPhase 1MIZAR-001NCT05417750
A Phase I Study of GC101 TIL in Advanced Solid Tumors
A Phase 1 study testing TIL therapy in people with Tumor Infiltrating Lymphocytes and Safety, run by Shanghai Juncell Therapeutics at 1 site in China.
Trial summary
20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a "3+3" dose escalation study and an expanded enrollment study. The Phase I clinical trial is expected to be finished in 36 months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tumor Infiltrating Lymphocytes, Safety, Advanced Solid Tumor
- What is being tested?
- TIL therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2022to 30 Oct 2025
- Phase
- Phase 1
- 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
- Patients must be ≥18 and ≤75 years of age at the time of consent.
- Patients with advanced metastatic solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.
- At least one measurable target lesion even after resection, as defined by RECIST1.1.
- Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatments was ≥3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients must have an estimated life expectancy of ≥3 months.
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- In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.
- Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function:
- 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；
- Patients must have a washout period ≥ 4 weeks from prior anticancer therapy(ies) to the start of the planned preconditioning regimen, including targeted therapy, chemotherapy, immunotherapy: anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)/anti-PD-1, other monoclonal antibody (mAb), or vaccine Palliative radiation therapy.
- Patients of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy.
- Patients must have no contraindications for surgery or biopsy.
- Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period.
Who cannot join
- Patients have not recovered from all prior therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] v5.0), except for alopecia or vitiligo, prior to Enrollment (tumor resection).
- Patients who have received an organ allograft or prior cell transfer therapy.
- Patients with symptomatic and/or untreated brain metastases (of any size and any number).
- Patients who are on chronic systemic steroid therapy for any reason.
- Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system.
- Patients with systemic active infection requiring treatment, with positive blood culture or imaging evidence of infection, including active tuberculosis.
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- Patients with hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe cirrhosis, or liver failure.
- Uncontrolled arterial hypertension（SBP≥160mmHg and/or DBP≥100mmHg）or any unstable cardiovascular or cerebrovascular disease in the recent 6 months of consent.
- Patients who have a left ventricular ejection fraction (LVEF) < 50% or New York Heart Association (NYHA) functional classification Class 3 or Class 4.
- Female patients who are pregnant or breastfeeding.
- Patients who are HIV positive, positive syphilis serological test, positive COVID-19 nucleic acid test, or clinically active hepatitis A, B, and C including virus carriers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-arm, Phase I Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Malignant Solid Tumors
20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a "3+3" dose escalation study and an expanded enrollment study.
The Phase I clinical trial is expected to be finished in 36 months. To be specific, the dose escalation study plans to include patients with advanced malignant solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.
- Conditions
- Tumor Infiltrating Lymphocytes, Safety, Advanced Solid Tumor, Immunotherapy, Efficacy, Adverse Drug Event
- Being tested
- TIL therapy
- Medical subject headings
- 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.
TIL therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cohort 1 | Experimental | dose escalation group: participants with advanced solid tumors using cryopreserved GC101 TIL Receives: Drug: TIL therapy |
| Experimental: Cohort 2 | Experimental | participants with advanced malignant melanoma using cryopreserved GC101 TIL Receives: Drug: TIL therapy |
| Experimental: Cohort 3 | Experimental | participants with advanced NSCLC using cryopreserved GC101 TIL Receives: Drug: TIL therapy |
| Experimental: Cohort 4 | Experimental | participants with advanced HNSCC using cryopreserved GC101 TIL Receives: Drug: TIL therapy |
| Experimental: Cohort 5 | Experimental | participants with advanced cervical cancer using cryopreserved GC101 TIL Receives: Drug: TIL therapy |
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 (5)
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
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
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
Disease Assessment for 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
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 posted14 Jun 2022
- Study start12 Oct 2022
- Primary completion30 Apr 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor Infiltrating LymphocytesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Juncell Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417750
- Sponsor's protocol ID
- GC101 TIL-ST-01
- Acronym
- MIZAR-001
- Status last verified
- Dec 2025
- First submitted
- 31 May 2022
- Last updated
- 10 Dec 2025
- 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 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Phase I Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05417750
- Acronym / sponsor ID
- MIZAR-001 / GC101 TIL-ST-01
- Conditions
- Tumor Infiltrating Lymphocytes, Safety, Advanced Solid Tumor, Immunotherapy, Efficacy, Adverse Drug Event
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Shanghai Juncell TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 14 Jun 2022 (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.
20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a "3+3" dose escalation study and an expanded enrollment study.
The Phase I clinical trial is expected to be finished in 36 months. To be specific, the dose escalation study plans to include patients with advanced malignant solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cohort 1 | Experimental | Drug: TIL therapydose escalation group: participants with advanced solid tumors using cryopreserved GC101 TIL |
| Experimental: Cohort 2 | Experimental | Drug: TIL therapyparticipants with advanced malignant melanoma using cryopreserved GC101 TIL |
| Experimental: Cohort 3 | Experimental | Drug: TIL therapyparticipants with advanced NSCLC using cryopreserved GC101 TIL |
| Experimental: Cohort 4 | Experimental | Drug: TIL therapyparticipants with advanced HNSCC using cryopreserved GC101 TIL |
| Experimental: Cohort 5 | Experimental | Drug: TIL therapyparticipants with advanced cervical cancer using cryopreserved GC101 TIL |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patients must be ≥18 and ≤75 years of age at the time of consent.
- Patients with advanced metastatic solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.
- At least one measurable target lesion even after resection, as defined by RECIST1.1.
- Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatments was ≥3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (11 listed)
- Patients have not recovered from all prior therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] v5.0), except for alopecia or vitiligo, prior to Enrollment (tumor resection).
- Patients who have received an organ allograft or prior cell transfer therapy.
- Patients with symptomatic and/or untreated brain metastases (of any size and any number).
- Patients who are on chronic systemic steroid therapy for any reason.
- Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system.
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 |
|---|---|---|
| TIL therapyA 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. | Drug | Experimental: Cohort 1, Experimental: Cohort 2, Experimental: Cohort 3, Experimental: Cohort 4, Experimental: Cohort 5 |
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
5 secondary outcomes
Disease Assessment for Duration of Response
Time frame: Every 6 weeks for 12 months
Disease Assessment for Disease Control Rate
Time frame: Every 6 weeks for 12 months
Disease Assessment for Progression-Free Survival
Time frame: Every 6 weeks for 12 months
Disease Assessment for Objective Response Rate
Time frame: Every 6 weeks for 12 months
Quality of Life Assessment
Time frame: Every 6 weeks for 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 TIL therapy 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 23 inclusion and 11 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 10 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?
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?
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 10 Dec 2025.