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.

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

20-60 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

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.

China1 site

Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039

Other trials in China

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 groups in NCT05417750
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.

12 Oct 202230 Oct 2025

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.
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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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