Breakthrough in Refractory Lung Cancer: China's GC101 TIL Therapy Achieves 41.7% Tumor Shrinkage, Set for 2026 NDA Filing
Juncell Therapeutics
Solid Tumor Cell Therapy Developer
KRAS G12DMutated Stage IV Lung Adenocarcinoma Patient, Fully Resistant to Chemotherapy and Immunotherapy, Given Only 3 Months to Live, Experienced Tumor Shrinkage After Receiving National Research TIL Therapy45%、Complete Relief of Cancer Pain; ROS1 fusion-positive advanced lung cancer patient with splenic metastasis after failure of multiple lines of treatment achieved a 33% tumor reduction and significant clinical improvement following the same therapy—successfully developed in ChinaGC101: The World’s First Natural TIL Therapy Requiring No Lymphodepletion, this innovative therapy developed in China has not only presented impressive clinical data at top international academic conferences, but recently also delivered major news:In 2026, Juncell Therapeutics’ GC101 will submit a marketing application, onceSuccessfully approved, it will become the first TIL therapy to be marketed in China，Patients in China are expected to have access to domestically developed TIL therapy in the near future.
Lung cancer, as the malignant tumor with the highest incidence and mortality rates in China, has seen numerous targeted and immunotherapeutic drugs reach the market, enabling countless patients to achieve long-term survival. However,Facing a severe survival challenge after developing drug resistance; furthermore,For patients without actionable mutations and with low PD-L1 expression,For patients with KRAS G12D, NRAS, and other mutations for which no marketed drugs are available, treatment options are extremely limited. Countless lung cancer patients and their families are desperately seeking a safe, effective, and tolerable innovative therapy, eager to seize a new ray of hope.
It is encouraging that,At the 2025 ESMO-IO Congress,Juncell Therapeutics' Self-Developed GC101 TIL TherapyThe inaugural release of Phase I clinical data has sent shockwaves through the global oncology community, bringing unprecedented hope to patients with advanced lung cancer.
Presented at the ESMO-IO Congress is a multicenter, open-label Phase I clinical trial (Trial No.: NCT05417750), led by Professor Xu Jianming from the Chinese PLA General Hospital. From August 2022 to September 2025, the study enrolled a total of 12 patients with advanced non-small cell lung cancer who had failed multiple lines of therapy. The medianTreatment lines reached third-line, it can be said that they are all “abandoned by traditional treatments”Patients in Critical Condition”。
After a median follow-up of 13.0 months (range: 1.5–31.0 months), GC101 delivered impressive efficacy results, with each data point offering hope to patients with advanced lung cancer and serving as the core foundation for its anticipated marketing authorization application in 2026:
Objective Response Rate (ORR) Reached 41.7%: This means that for every 10 patients with advanced-stage disease receiving third-line therapy, 4 experience significant tumor shrinkage. The efficacy far surpasses that of conventional later-line treatments, opening a window of survival for patients in dire circumstances;
Disease Control Rate (DCR) as high as66.7%: Nearly 70% of patients achieved effective disease control, preventing further tumor progression, extending survival time, and making "living with cancer" a reality;
Significantly Prolonged Survival: Median overall survival has not yet been reached; the 12-month overall survival rate is 66.7%, far exceeding the average survival of patients with advanced-stage, later-line lung cancer. The longest follow-up period has exceeded 31 months, with some patients continuing to benefit.
We believe the data above has already offered new hope to many lung cancer patients. Even more encouraging is that this represents the first registered clinical trial in China specifically dedicated to a TIL cell therapy for lung cancer.GC101 TIL therapy has already benefited numerous patients, with two clinically refractory cases achieving successful tumor shrinkage after treatment. This demonstrates the powerful efficacy of GC101 TIL therapy and brings hope to countless patients in desperate situations.
Patient A sought medical attention in April 2022 due to left chest pain and was diagnosed with stage IVB lung adenocarcinoma, unfortunately detectedKRAS G12D Mutation——This target, known as the "king of cancer kings," still has no approved targeted therapies available.
After attempting third-line regimens of immunotherapy combined with chemotherapy, and immunotherapy plus anti-angiogenic therapy combined with chemotherapy, each treatment ultimately failed, resulting in aggressive tumor progression.
Just at the moment of despair, I was fortunately enrolled in the study.GC101 TILClinical trial of the therapy: After a single infusion of GC101 cells, a miracle quietly occurred—tumor shrinkage had already reached45%Carcinoembryonic antigen levels returned to normal, the enlarged lymph nodes in the neck completely disappeared, and cancer-related pain was consequently alleviated; a life once deemed terminal was forcefully pulled back by this new domestic research technology.
Patient B was diagnosed with poorly differentiated adenocarcinoma of the left lung in May 2020, and detectedROS1 Fusion-Positive, initially relied on crizotinib to control the disease, but the improvement was short-lived as the condition gradually progressed. Subsequently, the patient received combination therapy with pemetrexed, carboplatin, and bevacizumab, as well as entrectinib treatment; however, none of these regimens succeeded in halting tumor progression. In October 2024, the tumor metastasized to the spleen, leading to continuous deterioration of the condition and declining physical status, leaving the patient in a dire situation with no further therapeutic options available.
Fortunately, participated inGC101 TILFollowing a single infusion of GC101 cells after the therapeutic clinical trial, tumor shrinkage was achieved at the 42-day efficacy assessment.33%, lactate dehydrogenase levels plummeted from 2,377 U/L prior to reinfusion to 258 U/L, with significant improvement in physical condition; discomforting symptoms such as cough and fatigue were markedly alleviated, reigniting hope for overcoming cancer.
After reviewing these inspiring data and case studies, patients are undoubtedly eager to learn more about the therapy Mr. Zhang received.
GC101 isShanghai Juncell TherapeuticsSuccessfully DevelopedThe World’s First Natural TIL Cell Therapy Requiring No Lymphodepletion and No IL-2 Injection, and was approved by the National Medical Products Administration to enter Phase I clinical trials in April 2022.Currently, it has entered the pivotal Phase II clinical trial (MIZAR-003), with patient enrollment underway at 24 centers across 20 provinces (including municipalities and autonomous regions) in China.
Clinical data show:For various advanced malignant solid tumors, including lung cancer, melanoma, and cervical cancer,GC101 demonstrated an objective response rate (ORR) of over 38%, with four patients achieving complete response (CR) and complete tumor clearance, including a longest disease-free survival duration exceeding two years. Additionally, six patients achieved a partial response (PR), defined as tumor shrinkage >30%.
This domestically developed, innovative TIL therapy differs from AMTAGVI™ (lifileucel), which is marketed in the United States, in that all patients can receive treatment in general wards; prior to TIL cell infusionNo need to undergo high-intensity non-myeloablative lymphodepleting preconditioning, and no dose of IL-2 needs to be infused after TIL cell infusion.The simplified clinical protocol still ensures effective proliferation of TIL cells in patients.Significantly reduce adverse reactions associated with the AMTAGVI™ Boxed Warning(e.g., treatment-related death, persistent severe cytopenia, severe infection, and impairment of cardiopulmonary and renal function)Significantly enhance the safety, convenience, and accessibility of TIL therapy.
2025Research findings presented at ASGCT demonstrate that Guoyan's independent innovationDeepTIL®Cell Enrichment and Expansion Platform(Dual-frEE Platform (feeder cell free and IL-2 free)), without trophoblasts and high concentrationIL-2can be successfully obtained from various solid tumor tissues(IncludingGliomas, sarcomas, ovarian cancer, colorectal cancer, gastric cancer, pancreatic cancer, etc."Cold Tumors" with Low Immune Cell Infiltration)amplified in sufficient quantity with high activity non-IL-2Dependent TypeTILcells, and without the need for combination with any doseIL-2demonstrated robust tumor-killing efficacy both in vivo and in vitro.
The innovative clinical protocol—eliminating the need for lymphodepleting chemotherapy prior to cell infusion, avoiding concomitant use of any dose of IL-2 post-treatment, and dispensing with sterile isolation rooms and intensive care during treatment—has been doubly endorsed by both subjects and investigators, who personally validated the scientific rigor and practical utility of these innovative research findings.
The good news is that, at presentClinical trials of GC101 for advanced melanoma and solid tumors are still ongoing, with many patients successfully enrolled through the Global Oncologist Network.
Aged 18–75 years, both male and female, without severe underlying diseases;
Having only one type of malignant solid tumor,Malignant Melanoma,Lung Cancer;
Failure of standard therapy or lack of effective treatment options;
At least 2 lesions are present, the patient’s physical condition can support surgical biopsy, and the biopsied lesions have not received prior local therapy (e.g., radiotherapy, radiofrequency ablation, oncolytic viruses, oncolytic bacteria, etc.).
For patients seeking assistance with TILs and other novel anticancer therapies available domestically and internationally, and who are financially capable, it is advisable to first submit their medical records to the Medical Department of Global Oncologist Network (400-666-7998) for preliminary evaluation. Upon approval, there may be an opportunity to receive complimentary treatment for these high-cost therapies.
In the past, failure after multiple lines of treatment for advanced lung cancer meant “no therapeutic options remained,” leaving countless patients to await their end in despair. Today, the emergence of GC101, a domestically developed TIL therapy, has broken this impasse. With an objective response rate of 41.7%, a disease control rate of 66.7%, two remarkable cases of patients turning the tide against all odds, and the significant announcement that market approval is expected to be filed in 2026, tangible hope for survival is now within reach for patients with advanced lung cancer.
This domestically developed innovative therapy, characterized by “no need for lymphodepletion, no requirement for IL-2, unrestricted target specificity, and high efficacy with a favorable safety profile,” not only fills the gap in tumor-infiltrating lymphocyte (TIL) therapy for lung cancer in China but also demonstrates the robust strength of Chinese scientific research. It holds promise to reshape the treatment landscape for advanced-stage lung cancer, offering renewed hope and survival opportunities to patients in critical conditions.
If you or your loved ones are struggling with advanced non-small cell lung cancer (NSCLC) and have failed multiple lines of treatment, including chemotherapy, targeted therapy, and immunotherapy, or even have no actionable targets, consider applying for the GC101 TIL therapy clinical trial. Perhaps this time, China’s innovative domestic technology can help you escape this dire situation and seize the opportunity for early access before its market launch in 2026. Like those two fortunate patients, you may be able to break free from cancer pain and embrace a normal life!
May every patient with advanced lung cancer seize this beacon of hope from China’s national research strength, never give up or retreat, ultimately conquer cancer, and honor the gift of life!
Case Source: Juncell Therapeutics
Scan to Add Patient Support Group
Cancer Treatment Information | New Technologies | New Drug Development | Authoritative Experts
Join the Group to Receive Free Anti-Cancer Materials
