China's First-in-Class TIL Therapy GC101 Shows 41.7% Tumor Shrinkage in Refractory Lung Cancer, Nears 2026 NDA Submission
Juncell Therapeutics
Solid Tumor Cell Therapy Developer
KRAS G12DPatient with Stage IVB Mutant Lung Adenocarcinoma, Resistant to Chemotherapy and Immunotherapy with Only 3 Months Survival Predicted, Achieves Tumor Shrinkage After Receiving China-Developed TIL Therapy45%、Cancer Pain Free; Patients with ROS1 fusion-positive advanced lung cancer, after multiple lines of treatment failed and the tumor metastasized to the spleen, experienced a 33% reduction in tumor size and significant improvement in physical condition following the same treatment — successfully developed in China.World's First Non-Myeloablative Natural TIL Therapy GC101This innovative Chinese-developed therapy not only unveiled impressive clinical data at a top international academic conference but has recently also delivered 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 expression of PD-L1,Patients with KRAS G12D, NRAS, and other mutations that do not have approved drugs face 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 ID: NCT05417750), led by Professor Jianming Xu from the Chinese PLA General Hospital. From August 2022 to September 2025, it enrolled 12 patients with advanced non-small cell lung cancer who had failed multiple lines of treatment. The median...The number of treatment lines has reached three lines., it can be said that they are all "abandoned by traditional treatments.Patients in Dire Straits”。
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 have achieved effective control of their condition, avoiding further progression of the tumor, and extending survival time for patients, 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 late-stage advanced lung cancer patients; the longest follow-up time has exceeded 31 months, with some patients continuing to benefit.
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 detected.KRAS 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 treatments, 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 already 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, detectedROS1 Fusion-PositiveInitially, the condition was controlled with crizotinib, but the effect did not last long 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 prevent tumor 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 therapy clinical trial, 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, reigniting hope for overcoming cancer.
Believe that after seeing the inspiring data and cases above, patients all want to know what kind of therapy Mr. Zhang received.
GC101 isJuncell Therapeutics (Shanghai)Successfully DevelopedThe World's First Natural TIL Cell Therapy Without Lymphodepletion and IL-2 Injection, and was approved by the National Medical Products Administration (NMPA) in April 2022 to enter Phase I clinical trials.Currently, it has entered the pivotal Phase II clinical trial (MIZAR-003) and is recruiting patients across 24 centers in 20 provinces (municipalities, autonomous regions) of China.
Clinical data show:For advanced malignant solid tumors such as lung cancer, melanoma, and cervical cancer,GC101 Achieves an Objective Response Rate (ORR) Exceeding 38%, with Four Patients Experiencing Complete Tumor Clearance, Reaching Complete Remission (CR). The Longest Disease-Free Survival Time Has Surpassed 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 AMTAGVI™ (Lifileucel), which is available in the U.S. 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 derive from various types of solid tumor tissues(IncludingGlioma, Sarcoma, Ovarian Cancer, Colorectal Cancer, Gastric Cancer, Pancreatic Cancer, etc."Cold Tumors" with Minimal Immune Cell Infiltration)Amplified in China to produce a sufficient amount of highly active 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 lymphodepletion chemotherapy before infusion, nor do they need to be treated with any dose of IL-2 after treatment. During the treatment period, there is no need for admission to a sterile ward or implementation of intensive care. These innovative clinical strategies have been doubly recognized by both participants and researchers, who have personally verified the scientific and practical nature of this innovative research outcome.
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 Cancer Doctors 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 standard treatment or lack of effective treatment methods;
At least 2 lesions are present, the patient's physical condition allows for surgical biopsy, and the biopsied lesions have not received local treatments (such as radiotherapy, radiofrequency ablation, oncolytic virus, or oncolytic bacteria).
If you wish to seek help for TILs and other new anti-cancer treatments available in China and abroad, and your financial situation allows, you can first submit your medical records to the Medical Department of Global Cancer Doctors Network (400-666-7998) for an initial evaluation. Once approved, there is a chance to receive free treatment with "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 situations, and the significant news of expecting to file for marketing approval by 2026, all bringing tangible survival hope to patients with advanced lung cancer.
This "no need for pre-conditioning, no need for IL-2,不限靶点, efficient and safe" innovative therapy researched and 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, with the potential to reshape the treatment landscape for advanced lung cancer in the future, bringing 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 may consider applying for the GC101 TIL therapy clinical trial—perhaps this time, the innovative technology developed in China by Juncell Therapeutics can lead you out of the desperate situation and allow you to seize the opportunity to benefit early before its expected market launch in 2026. Just 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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