China's First IL-2- and Lymphodepletion-Free TIL Therapy GC101 Shows 41.7% ORR in Heavily Pretreated NSCLC, Set for NDA Submission in 2026
Juncell Therapeutics
Solid Tumor Cell Therapy Developer
KRAS G12DPatient with Stage IVB Mutant Lung Adenocarcinoma, Resistant to Chemotherapy and Immunotherapy with Only 3 Months of Predicted Survival, Achieves Tumor Shrinkage After Receiving China-Developed TIL Therapy45%、Cancer Pain Gone; Patients with ROS1 fusion-positive advanced lung cancer, after multiple lines of treatment failure and tumor metastasis to the spleen, experienced a 33% reduction in tumor size and significant improvement in health following the same therapy - successfully developed in China.World's First Non-Lymphodepletion Natural TIL Therapy GC101This innovative Chinese-developed therapy, which has not only revealed impressive clinical data at top international academic conferences, but has also recently announced significant news:In 2026, Juncell Therapeutics' GC101 will submit an application for market approval, onceSuccessfully approved, it will become the first TIL therapy to be launched in China.，Patients in China are expected to welcome domestically developed TIL therapy in the near future.
Lung cancer, as the malignant tumor with the highest incidence and mortality rate in China, despite the availability of numerous targeted and immune drugs that have enabled countless patients to achieve long-term survival, butFacing severe survival challenges after developing resistance; moreoverFor those without mutant targets and low PD-L1 expression,Patients with KRAS G12D, NRAS, and other mutations that do not have approved drugs have very limited treatment options. Countless lung cancer patients and their families are desperately seeking a safe, effective, and tolerable innovative therapy, hoping to seize a new chance at life.
What is encouraging is that,At the 2025 ESMO-IO Congress,GC101 TIL Therapy Independently Developed by Juncell TherapeuticsThe first release of Phase I clinical data shocked the global oncology community and brought unprecedented hope to patients with advanced lung cancer.
The study presented at the ESMO-IO conference is a multicenter, open-label Phase I clinical trial (Trial registration number: NCT05417750), led by Professor Jianming Xu from the Chinese PLA General Hospital. From August 2022 to September 2025, a total of 12 patients with advanced non-small cell lung cancer who had failed multiple lines of treatment were enrolled in the study. The median...The number of treatment lines has reached three lines., it can be said that they are all "abandoned by traditional treatments.End-stage patients”。
After a median follow-up of 13.0 months (range: 1.5-31.0 months), GC101 delivered stunning efficacy results, with each set of data bringing hope to patients with advanced lung cancer and becoming the core confidence for its potential market application in 2026:
Objective Response Rate (ORR) Reached 41.7%: This means that in every 10 patients with advanced third-line conditions, 4 patients experience significant tumor shrinkage. The efficacy far exceeds traditional later-line treatments, offering a survival breakthrough for patients in desperate situations;
Disease Control Rate (DCR) as high as66.7%: Nearly 70% of patients had their conditions effectively controlled, avoiding further tumor progression, and prolonging survival time, making "living with tumors" possible;
Significant Extension of Survival Period: The median overall survival has not yet been reached, with a 12-month overall survival rate of 66.7%, far exceeding the average survival period for advanced-line lung cancer patients. The longest follow-up time has exceeded 31 months, and some patients are still benefiting continuously.
The data above has surely brought new hope to many lung cancer patients. More encouragingly, this is the first TIL cell drug registration clinical trial in China specifically targeting lung cancer.Have already benefited numerous patients; two clinically challenging cases successfully achieved tumor shrinkage after treatment, truly demonstrating the powerful strength of GC101 TIL therapy, and bringing 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, further tests revealedKRAS G12D Mutation——This target, known as the "king of cancer among cancer kings," still has no available targeted drugs on the market.
After attempting combination therapies of immunotherapy + chemotherapy, and immunotherapy + anti-angiogenesis + chemotherapy as third-line treatment options, each treatment ended in failure with the tumor progressing aggressively.
Just as despair set in, they were fortunate enough to be enrolled.GC101 TILClinical trials of the therapy showed that, after receiving a single infusion of GC101 cells, a miracle quietly occurred: by the 42-day efficacy evaluation, the tumor had significantly shrunk.45%, carcinoembryonic antigen returned to normal, the enlarged lymph nodes in the neck completely disappeared, and the cancer pain was also relieved. A life that was originally sentenced to death was brought back by China's new national research technology.
Patient B was diagnosed with poorly differentiated adenocarcinoma of the left lung in May 2020, and tested positive forROS1 Fusion-PositiveInitially, the condition was controlled with crizotinib, but the effect was short-lived as the disease gradually progressed. Subsequently, the patient underwent combination therapy with pemetrexed, carboplatin, and bevacizumab, followed by entrectinib treatment. However, none of these regimens could halt the tumor's progression. In October 2024, the cancer metastasized to the spleen, the condition continued to deteriorate, and the patient’s physical state worsened, leaving them in a dire situation with no available treatment options.
Fortunately, I participated inGC101 TILAfter receiving a single GC101 cell infusion following the clinical trial of the therapy, the tumor had shrunk by the 42-day efficacy evaluation.33%, lactate dehydrogenase plummeted from 2377 U/L before infusion to 258 U/L, with a significant improvement in physical condition. Symptoms such as cough and fatigue were notably alleviated, rekindling hope for overcoming cancer.
Believe that after reading the above inspiring data and cases, patients all want to know what kind of therapy Mr. Zhang received.
GC101 isJuncell TherapeuticsSuccessfully DevelopedThe World's First Natural TIL Cell Therapy That Requires No Lymphodepletion and No 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) and is recruiting patients at 24 centers across 20 provinces (municipalities and autonomous regions) in China.
Clinical data show:For advanced malignant solid tumors such as lung cancer, melanoma, and cervical cancer,GC101 Achieves an Objective Response Rate (ORR) of Over 38%, with Four Patients Experiencing Complete Tumor Clearance, Reaching Complete Remission (CR). The Longest Disease-Free Survival Time Has Exceeded Two Years. Additionally, Six Patients Have Achieved Partial Remission (PR) with Tumor Reduction Greater Than 30%.
This domestically innovative TIL therapy, developed in China, differs from the U.S.-approved AMTAGVI™ (Lifileucel). All patients only need to stay in a general ward to receive treatment before the TIL cell infusion.No need to undergo high-intensity non-myeloablative lymphodepletion preconditioning, and no infusion of any dose of IL-2 is required after TIL cell infusion.The simplified clinical protocol can still ensure the effective proliferation of TIL cells in patients.Maximally Avoid AMTAGVI™ Black Box Warning-Related Adverse Reactions(such as: treatment-related mortality events, persistent severe cytopenia, serious infections, cardiopulmonary and renal function impairment, etc.) occurrence risk,Greatly improve the safety, convenience, and accessibility of TIL therapy.
2025Research results published at ASGCT show that Juncell Therapeutics independently developed in ChinaDeepTIL®Cell Enrichment and Expansion Platform(Dual-frEE Platform (feeder cell free and IL-2 free)), without the need for trophoblasts and high concentrationIL-2Can successfully extract from various types of solid tumor tissues(IncludingGlioma, Sarcoma, Ovarian Cancer, Colorectal Cancer, Gastric Cancer, Pancreatic Cancer, etc."Cold Tumors" with Low Immune Cell Infiltration)Amplification of sufficient high-activity non-IL-2Dependent TypeTILCells, and without the need for combination with any dosageIL-2In this case, it demonstrated good tumor-killing ability both in vivo and in vitro.
Patients do not need to undergo lymphodepleting chemotherapy before infusion, nor do they need to be treated with any dose of IL-2 after treatment. Additionally, there is no requirement for admission to a sterile ward or intensive care during treatment. These innovative clinical strategies have gained recognition from both subjects and researchers, personally demonstrating the scientific and practical value of this innovative research achievement.
The good news is that, currentlyClinical trials of GC101 for advanced melanoma and solid tumors are still ongoing, and many patients have successfully enrolled through the Global Oncology MD Network.
Aged 18-75, regardless of gender, without severe underlying diseases;
Suffering from only one type of malignant solid tumor,Malignant Melanoma,Lung Cancer;
Failed after standard treatment or lack of effective treatment methods;
At least two lesions are present, the patient's physical condition can support surgical sampling, and the sampled lesions have not received local treatments (such as radiotherapy, radiofrequency therapy, oncolytic virus, or oncolytic bacteria).
Those who wish to seek help from TILs and other new domestic and international anti-cancer treatments, and have the financial means, can first submit their medical records to the Medical Department of Global Oncology Doctors Network (400-666-7998) for an initial evaluation. Once approved, they may have the opportunity to receive free treatment of "astronomically priced" therapies.
Once, after the failure of multiple lines of treatment for advanced lung cancer, it meant "no available treatment," and countless patients awaited the end in despair; now, the emergence of Juncell Therapeutics' GC101 TIL therapy has broken this deadlock – with an objective response rate of 41.7%, a disease control rate of 66.7%, two cases of patients turning the tables in dire straits, and the significant news of expecting to apply for marketing by 2026, all bringing tangible survival hope to patients with advanced lung cancer.
This "no need for lymphodepletion, no need for IL-2, unrestricted targets, highly efficient and safe" innovative therapy developed in China not only fills the gap in TIL treatment for lung cancer in China but also demonstrates the strong capabilities of Chinese research. In the future, it is expected to reshape the treatment landscape for advanced lung cancer, offering new hope to more patients in desperate situations.
If you or your family members and friends are troubled by advanced non-small cell lung cancer, and have failed multiple lines of treatment such as chemotherapy, targeted therapy, and immunotherapy, or even have no target available, you might as well try applying for the GC101 TIL therapy clinical trial—perhaps this time, the innovative technology developed in China will lead you out of the predicament, allowing you to seize the opportunity to benefit early before its expected market launch in 2026. Like those two fortunate patients, you may be able to get rid of cancer pain and embrace a normal life!
May every patient with advanced lung cancer grasp this beam of hope from China's national research strength, never give up, never retreat, and ultimately conquer cancer, living up to life!
Case Source: Juncell Therapeutics
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