Qinghui Lianuo's Global First-in-Class Allogeneic CAR-γδ T Cell Therapy QH104A Receives CDE IND Acceptance with 100% Disease Control Rate in Early Trials

Jul 08, 2025 10:56 CST Updated 10:56

Unicet Biotech

Developer of γδ T Cell Therapeutics

Recently, Beijing Qinghui Lianuo Biotechnology Co., Ltd. (hereinafter referred to as "Qinghui Lianuo") independently developed the world's first allogeneic universal CAR-γδ T cell injection targeting B7H3, QH104A.New Drug Clinical Trial (IND) ApplicationAccepted by the CDE. It is reported that the drug has already been approved by the FDA.IND approval,It is the world's first CAR-γδ2 T cell candidate drug to receive FDA IND approval, and also the only allogeneic CAR-T therapy for malignant glioma currently approved by the FDA for clinical trials.

Breaking the Treatment Dilemma of the "Cancer King": A Two-Decade Clinical Stalemate May Be Thawing

High-grade gliomas, as the most aggressive malignant tumors in the central nervous system, have always been a "tough challenge" in the field of cancer treatment. Glioblastoma, which has the highest incidence rate (accounting for approximately 50% of high-grade gliomas), offers patients a median overall survival of only 14-16 months after diagnosis, with an expected survival of just 6-8 months after recurrence. The five-year survival rate is less than 7%. Traditional therapies struggle to break through efficacy bottlenecks due to challenges such as the blood-brain barrier and high tumor heterogeneity. The QH104A cell therapy innovatively integrates the natural anti-tumor properties of γδ T cells with the precise targeting advantages of CAR-T technology. Data from investigator-initiated clinical trials (IIT) already conducted show that it can significantly extend patient survival, potentially breaking the two-decade-long deadlock of no breakthrough therapies in this field, bringing hope to glioma patients worldwide.

At the last European Society for Medical Oncology (ESMO) Annual Congress, Qinghui Lianuo announced the first-in-human Phase 1 clinical trial of QH104 in treating patients with recurrent glioblastoma (rGBM). The primary objective of this clinical study is to evaluate the safety and tolerability of intrathecal infusion of QH104 in treating B7H3-positive rGBM, while the secondary objectives are to assess the pharmacokinetic characteristics and preliminary efficacy of the reinfused cells. Participants received intrathecal injections of QH104, with doses escalating according to the "3+3" method (1/3/10×10).⁷CAR+ cells), administered once a month.

As of March 30, 2024, a total of 7 patients (2 female, 5 male, median age 60 years, age range 31-66 years) with high-grade rGBM received more than one intrathecal infusion of QH104. The median observation time was 6.5 months, ranging from 3 to 10 months. Subjects tolerated the treatment well without dose-limiting toxicity (DLT). The most common adverse events were fever and headache, accompanied by elevated levels of IL-6 and IFN-γ in cerebrospinal fluid. No grade 3 or higher severe cytokine release syndrome (CRS) or ICANS occurred, and no graft-versus-host disease (GvHD) was observed.

Efficacy data showed that the objective response rate (ORR) was 42.9% in 7 patients, with a disease control rate (DCR) of 100%. QH104 also demonstrated good persistence, with the infused cells still detectable by flow cytometry and qPCR 30 days after administration. Preliminary stratified analysis found that clinical efficacy was positively correlated with B7H3 expression levels. The researchers believe that QH104 has good safety and promising clinical potential for treating B7H3-positive rGBM patients.

Setting New Standards in Cell Therapy: Off-the-Shelf Medicines Benefit Patients Worldwide

QH104A, relying on Qinghui Lianuo's independently developed fully enclosed semi-automated production process system, has achieved a breakthrough in the scaled preparation of cellular drugs, significantly reducing the production cost per dose. Meanwhile, its "allogeneic off-the-shelf" design overcomes the limitations of personalized preparation, allowing the drug to be stored in liquid nitrogen for an extended period, forming an "off-the-shelf" drug reserve that greatly shortens patient waiting time and avoids delays in treatment. The approval of QH104A for clinical trials represents the regulatory authority's recognition of Qinghui Lianuo’s scaled allogeneic cell drug production process based on γδ T cells. This process can be expanded to more candidate products, providing an industrial model for developing more affordable and accessible cellular drugs.

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