Breakthrough in Refractory Lung Cancer: China-Developed TIL Therapy GC101 Achieves 41.7% Tumor Shrinkage and Nears Market Approval
Juncell Therapeutics
Solid Tumor Cell Therapy Developer
KRAS G12DPatient with Stage IVB Lung Adenocarcinoma and Multiple Mutations, Fully Resistant to Chemotherapy and Immunotherapy and Given a Three-Month Survival Prognosis, Achieved Tumor Shrinkage After Receiving Nationally Developed TIL Therapy45%、Complete Relief from Cancer Pain; In a ROS1 fusion-positive advanced lung cancer patient with splenic metastasis after failure of multiple lines of therapy, tumor shrinkage of 33% and significant clinical improvement were achieved with the same therapeutic regimen—successfully developed in ChinaThe World's First Natural TIL Therapy GC101 Without Lymphodepletion, this innovative therapy developed by Chinese researchers 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, onceApproved, it will become the first TIL therapy to be marketed in China.，Domestic patients are expected to gain access to independently 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 immunotherapy drugs approved for market entry, enabling countless patients to achieve long-term survival. However,Facing severe survival challenges 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 approved therapies are currently available, treatment options are extremely limited. Countless lung cancer patients and their families are earnestly seeking a safe, effective, and tolerable innovative therapy, hoping to seize a new ray of hope.
It is encouraging that,At the 2025 ESMO-IO Congress,Juncell Therapeutics' Independently Developed GC101 TIL TherapyThe first-ever release of Phase I clinical data has stunned the global oncology community and brought unprecedented hope to patients with advanced lung cancer.
Presented at the ESMO-IO Congress, this is a multicenter, open-label Phase I clinical trial (Trial ID: 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 line reaches the third line, can be said to have been abandoned by traditional therapies as “Patients in Critical Condition”。
After a median follow-up of 13.0 months (range: 1.5–31.0 months), GC101 has 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 among every 10 patients with third-line late-stage disease, 4 experience significant tumor shrinkage. The therapeutic efficacy far surpasses that of conventional later-line treatments, opening a window for survival in patients with limited options;
Disease Control Rate (DCR) up to66.7%: Nearly 70% of patients achieved effective disease control, preventing further tumor progression and extending survival time, thereby making "living with cancer" a possibility;
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, heavily pretreated lung cancer. The longest follow-up period has exceeded 31 months, with some patients continuing to derive benefit.
We believe the above data has offered new hope to many lung cancer patients. Even more encouraging is that this marks the first registered clinical trial in China for a TIL cell therapy specifically targeting lung cancer.It has already benefited numerous patients. Two patients with clinically refractory conditions successfully achieved tumor shrinkage after treatment, truly demonstrating the powerful efficacy of the GC101 TIL therapy and bringing hope to countless patients in dire situations.
Patient A sought medical attention in April 2022 for left-sided chest pain and was diagnosed with stage IVB lung adenocarcinoma, with unfortunate detection ofKRAS G12D Mutation—To date, no approved targeted therapy is available for this target, known as the “king of cancer kings.”
After attempting third-line regimens of immunotherapy combined with chemotherapy and immunotherapy plus anti-angiogenic therapy combined with chemotherapy, each treatment ended in failure, with rampant tumor progression.
Just at the brink of despair, I was fortunately enrolled in the trial.GC101 TILClinical trials of the therapy, after receiving only a single infusion of GC101 cells, a miracle quietly occurred: at the 42-day efficacy assessment, tumor shrinkage had reached45%, carcinoembryonic antigen levels returned to normal, the enlarged cervical lymph nodes 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-PositiveInitially, the disease was controlled with crizotinib treatment, but the improvement was short-lived as the condition gradually progressed. The patient subsequently 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 and marked alleviation of discomforts such as cough and fatigue, reigniting hope for overcoming cancer.
After reviewing the inspiring data and case studies above, patients are undoubtedly eager to learn more about the specific therapy Mr. Zhang received.
GC101 isShanghai Juncell TherapeuticsSuccessfully DevelopedThe World's First Natural TIL Cell Therapy Requiring No Lymphodepletion or IL-2 Injection, and was approved by the National Medical Products Administration (NMPA) to enter Phase I clinical trials in April 2022.Currently, it has entered the pivotal Phase II clinical trial (MIZAR-003), with patient recruitment 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,The objective response rate (ORR) of GC101 exceeded 38%, with four patients achieving complete tumor clearance and attaining complete response (CR); the longest duration of tumor-free survival among these patients has surpassed 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 high-intensity non-myeloablative lymphodepleting preconditioning is required, and no dose of IL-2 needs to be infused after TIL cell reinfusion.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 deaths, persistent severe cytopenia, severe infections, and cardiopulmonary and renal impairment)Significantly Enhance the Safety, Convenience, and Accessibility of TIL Therapy.
2025Research findings presented at the ASGCT demonstrate that Guoyan’s independent innovationDeepTIL®Cell Enrichment and Expansion Platform(Dual-frEE Platform (feeder cell free and IL-2 free)), without trophoblastic cells and high concentrationIL-2successfully from various solid tumor tissues(IncludingGliomas, sarcomas, ovarian cancer, colorectal cancer, gastric cancer, pancreatic cancer, etc."Cold Tumors" with Minimal Immune Cell Infiltration)amplified in sufficient quantities with high activityIL-2Dependent TypeTILcells, and without the need for combination with any doseIL-2under these conditions, it demonstrates robust tumor-killing efficacy both in vivo and in vitro.
The clinical innovations—eliminating the need for lymphodepleting chemotherapy prior to cell infusion, avoiding the concurrent use of any dose of IL-2 post-treatment, and obviating the requirement for sterile isolation rooms and intensive care during treatment—have been doubly endorsed by both subjects and investigators, providing firsthand empirical validation of the scientific rigor and practical utility of this innovative research outcome.
The good news is that, currentlyClinical 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 sexes, without severe underlying diseases;
Having only one malignant solid tumor,Malignant Melanoma,Lung cancer;
Failure of standard treatment or lack of effective therapeutic options;
At least two lesions are present, the patient’s physical condition can support surgical biopsy, and the biopsied lesions have not received prior local therapy (such as radiotherapy, radiofrequency ablation, oncolytic virus, or oncolytic bacteria).
For patients seeking assistance with TIL therapy and other novel anticancer treatments available domestically and internationally, and who are financially capable, it is recommended 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.
Once, failure of multiple lines of treatment in advanced lung cancer meant “no further therapeutic options,” leaving countless patients to await their end in despair. Today, the emergence of the domestically developed GC101 TIL therapy has broken this impasse—boasting an objective response rate of 41.7% and a disease control rate of 66.7%, along with miraculous turnarounds in two patients facing dire prognoses. The significant news that marketing approval is expected to be filed in 2026 is bringing tangible hope for survival to patients with advanced lung cancer.
This domestically developed innovative therapy, characterized by its “no lymphodepletion required, no IL-2 needed, unrestricted target specificity, and high efficacy with safety,” not only fills the gap in TIL therapy for lung cancer in China but also demonstrates the robust strength of Chinese scientific research. It holds the promise of reshaping the treatment landscape for advanced lung cancer in the future, offering renewed hope for survival to many patients in critical conditions.
If you or your loved ones are struggling with advanced non-small cell lung cancer (NSCLC) and have experienced failure after multiple lines of treatment—including chemotherapy, targeted therapy, and immunotherapy—or even lack actionable targets, consider applying for the GC101 TIL therapy clinical trial. This domestically developed innovative technology may offer a way out of this desperate situation, allowing you to seize the opportunity for early access before its market launch in 2026. Like the two fortunate patients who have already benefited, you too could 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, and ultimately triumph over cancer, honoring the gift of life!
Case Source: Juncell Therapeutics
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