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Non Small Cell Lung Cancer MetastaticPhase 1MIZAR-005NCT06473961

A Phase Ib Study of GC101 in NSCLC

A Phase 1 study testing Autologous Tumor Infiltrating Lymphocytes in people with Non Small Cell Lung Cancer Metastatic and Non Small Cell Lung Cancer, 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
Search all trials

Trial summary

20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 36 months. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Autologous Tumor Infiltrating Lymphocytes
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
14 Oct 2024to 1 Jul 2028
Phase
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;
  • 2. Aged ≥18 years and ≤70 years, regardless of gender;
  • 3. Patients with unresectable advanced, recurrent, or metastatic non-small cell lung cancer who are positive for driver genes and have failed after targeted and platinum-containing dual chemotherapy;
  • 4. 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;
  • 5. 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;
  • 6. ECOG performance status 0-1;
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  • 7. Expected survival time >3 months;
  • 8. 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#
  • 9. * 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;
  • 10. No absolute or relative contraindications for surgery;
  • 11. 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;
  • 12. Good compliance and able to adhere to the study visit plan and other agreement requirements.

Who cannot join

  • 1. More than 5-line system therapy had been used in previous 3 years before screening period.
  • 2. Participation in a clinical trial of another drug or biologic therapy or receipt of a comparable cellular therapy within 28 days prior to infusion;
  • 3. 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;
  • 4. Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;
  • 5. 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);
  • 6. Known history of allergy to streptomycin, ciprofloxacin, or micafungin or allergy to any component of the infused product formulation;
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  • 7. 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) ;
  • 8. 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;
  • 9. 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;
  • 10. Hepatic encephalopathy, hepatorenal syndrome or child-pugh class b or more severe cirrhosis, liver failure;
  • 11. Comorbidity with other serious organic or psychiatric disease;
  • 12. Have an active systemic infection requiring treatment with positive blood cultures or imaging evidence of infection, including but not limited to active tuberculosis;
  • 13. 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;
  • 14. Active autoimmune diseases that still require systemic steroid hormones or other immunosuppressive drugs during the screening period (greater than 10 mg/ day of prednisone or equivalent doses of other hormones);
  • 15. Any nci ctcae5.0 immune-related adverse effect (irae) grade ≥ 3 during any prior period of immunotherapy receipt;
  • 16. History of organ allograft, allogeneic stem cell transplantation and renal replacement therapy; History of allogeneic t-cell and nk-cell therapy;
  • 17. Pulmonary fibrosis, interstitial lung disease (both past history and current), and acute lung disease; Patients with obstructive or restrictive lung disease with FEV1(forced expiratory volume in 1 second) of lung function ≤70%;
  • 18. Clinically uncontrollable third space effusions, such as pleural and abdominal effusions that cannot be controlled by drainage or other means prior to enrollment;
  • 19. 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;
  • 20. Women who are pregnant or breastfeeding;
  • 21. If the investigator believes that other circumstances are not suitable for enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shun Lu, M.D. contact

86-021-22200000

shunlu_shchest@sina.com

China1 site, 1 recruiting

  • Shanghai Chest Hospital

    Shanghai

    Shun Lu, 02122200000, shunlu_shchest@sina.com

    Recruiting

Other trials in China

About this study

Official title: An Open-Label, Single-armed, Phase Ib Study to Evaluate the Safety and Efficacy Using Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Non-Small Cell Lung Cancer

20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 36 months.

Being tested
Autologous Tumor Infiltrating Lymphocytes
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Autologous Tumor Infiltrating LymphocytesBiological

    Also called GC101 TIL injection

    A tumor sample is resected from each participant and cultured ex vivo to generate tumor infiltrating lymphocytes. After lymphodepletion, patients are infused GC101 TIL followed low-dose PD-1 antibody.

Study groups in NCT06473961
Study groupRoleWhat they receive
Treatment ArmExperimentalParticipants with advanced NSCLC using cryopreserved GC101 TIL
Receives: Biological: Autologous Tumor Infiltrating Lymphocytes

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: 18 weeks

Secondary outcomes (7)

  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 36 months

  3. Best overall response

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

    Measured: Maximum 36 months

  4. Disease Control Rate

    Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST

    Measured: Maximum 36 months

  5. Progression-Free Survival

    Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST

    Measured: Maximum 36 months

  6. Duration of Response

    Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST

    Measured: Maximum 36 months

  7. overall survival

    Evaluate the efficacy endpoints of OS

    Measured: Maximum 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 posted25 Jun 2024
  2. Study start14 Oct 2024
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jul 2028 (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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06473961
Sponsor's protocol ID
GC101 TIL-NSCLC-Ib
Acronym
MIZAR-005
Status last verified
Dec 2025
First submitted
18 Jun 2024
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 Phase 1 study testing Autologous Tumor Infiltrating Lymphocytes in people with Non Small Cell Lung Cancer Metastatic and Non Small Cell Lung Cancer, 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 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 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?

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 Shun Lu, M.D. (86-021-22200000, shunlu_shchest@sina.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: 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 NCT06473961.

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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