A Phase Ib Study of GC101 in NSCLC

NCT06473961 | Recruiting Phase 1

• 1 other identifier: GC101 TIL-NSCLC-Ib
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non Small Cell Lung Cancer; Non Small Cell Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Incidence of adverse events associated with GC101 TIL retransfusion

  Up to Day 28

• Objective Response Rate

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

  18 weeks

Secondary Outcomes (7)

• Adverse Events

  Maximum 360 days

• Objective Response Rate

  Maximum 36 months

• Best overall response

  Maximum 36 months

• Disease Control Rate

  Maximum 36 months

• Progression-Free Survival

  Maximum 36 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Participants with advanced NSCLC using cryopreserved GC101 TIL

Biological: Autologous Tumor Infiltrating Lymphocytes

Interventions

Autologous Tumor Infiltrating Lymphocytes BIOLOGICAL

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.

Also known as: GC101 TIL injection

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;
• \. Aged ≥18 years and ≤70 years, regardless of gender;
• \. 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;
• \. 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;
• \. 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

You may not qualify if:

• \. More than 5-line system therapy had been used in previous 3 years before screening period.
• \. 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) ;
• \. 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;
• \. 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);
• \. Any nci ctcae5.0 immune-related adverse effect (irae) grade ≥ 3 during any prior period of immunotherapy receipt;

Sponsors & Collaborators

• Shanghai Juncell Therapeutics: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Shun Lu, M.D.

CONTACT

86-021-22200000; shunlu_shchest@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: October 14, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)